Enhanced Recovery After Cesarean Protocol Versus Traditional Protocol in Elective Cesarean Section

A Prospective Observational Study

Abstract

Background: 

Enhanced recovery programs result in reduced morbidity in terms of effective pain control, reduced length of stay (LOS), and an earlier return to normal activities. This study has been conducted to compare Enhanced recovery after caesarean (ERAC) protocol to traditional care of cesarean section (CS) in our institute.

Materials and Methods: 

Patients undergoing elective CS were subjected to ERAC protocol (Group A; n = 100) for first six months and traditional protocol (Group B; n = 100) for next six months. Primary outcome was comparison of total duration of stay (readiness to discharge) in the hospital, whereas secondary objectives were intraoperative hemodynamic control and requirement of vasopressor, comparison of Visual Analogue Scale (VAS) scores and requirement of analgesics in 24 hrs, barriers to implementation of ERAC components, urinary retention and need of recatheterization and any adverse events perioperatively.

Results: 

Significant reduction in LOS or readiness for discharge was found in Group A; 2.85 ± 0.5 vs 5.25 ± 0.61 hrs in Group B (p < 0.0001). Episodes of hypotension and requirement of phenylephrine was significantly more in Group B. (p < 0.0001) VAS scores in Group A were significantly less postoperatively with significant reduction in consumption of rescue analgesic in 24 hrs. (p < 0.001) Components of ERAC protocol were implemented successfully with significant difference in time of ambulation, decatheterization, and resumption of oral feed postoperatively.

Conclusion: 

Implementation of ERAC results in significant reduction in LOS in hospital with better pain relief and reduced postoperative opioid requirement following cesarean delivery.

Introduction

Cesarean delivery is one of the most commonly performed surgical procedures in obstetric population with a rate of approximately 21.1% (2010–2018) of total live births worldwide. According to World Health Organization this figure will increase further to 28.5% by the year 2030.[¹] This huge volume of cesarean deliveries and increasing cesarean section rate has an incremental burden on healthcare system, leading to higher bed occupancy and financial pressure on the patients and health facilities. Early recovery after caesarean (ERAC) guidelines were first introduced in 2018 long after the development of Enhanced recovery after surgery (ERAS) protocol in other surgical specialities to maintain the balance of recovery from major abdominal surgery along with an infant care. According to The National Institute for Health and Care Excellence women who are recovering well, are apyrexial and do not have complications following CS should be offered early discharge (after 24 hrs) from hospital and followed up at home, as it is not associated with more infant or maternal readmissions.[²] ERAC has gone popular and well adopted in Western countries but in developing countries like India the implementation is facing network and infrastructural issues. Besides poor level of literacy of target population, big rural and urban divide with inability to recognise early warning signs and lack of trained staff for ERAS protocols are the prime barriers for implementation of ERAC for this subset of population.[³] This study was aimed at providing this holistic approach of patient care to parturient undergoing CS with simultaneously looking for the major barriers coming across.

Materials and Method

After obtaining approval from institutional research ethical board (HREC APPROVAL NO: - GU/HREC/EC/2019/785) and clinical trial registration (CTRI/2021/01/030532), this prospective observational study was performed in accordance with the Declaration of Helsinki at a tertiary care hospital, over a period of one year, from December 2019 to November 2020. A written informed consent from all the patients before participation in the study was obtained.

In this prospective study, traditional protocol was compared to an enhanced recovery after cesarean (ERAC) protocol for parturients who underwent elective cesarean section.

On the basis of Pilot study done on 20 patients in the same setting, an average reduction in day of discharge from 5.5 days to 2.5 days (SD 0.52 and 1.08, respectively), was observed. With a power of 80% (α error 5%, β error 20% i.e.; 95% confidence level) a sample size of 125 patients was calculated using the formula for difference in mean and standard deviation. Considering 10% exclusions and dropouts and to reject the null hypothesis, total of 135 patients were included in each group (Group A: ERAC protocol; Group B: Traditional protocol) All term patients (>37 week of gestation), between 18 and 40 years of age with American Society of Anesthesiology Grade I–II scheduled for elective cesarean section were included in the study. Patients excluded from analysis included existing cardiac disease, diabetes, autoimmune disorder, pre-eclampsia or eclampsia, and known allergy to any of the study protocol drug or opioid use disorder. Patients were observed for traditional protocol for first six months and for enhanced recovery protocol for next six months.

A multi-disciplinary team comprising anesthesiologists, obstetricians, neonatologists, and nursing professional, gathered to discuss the change in peri-partum management of patient undergoing elective cesarean section. After going through various guidelines proposed by Society of Obstetric Anaesthesia and Perinatology, American College of Obstetrics and Gynaecology, and ERAC society and extensive discussion, strategies for standardization of care were decided. Broadly major components, which were key to improved outcome according to previous research and found feasible to implement in our hospital were included in the revised ERAC protocol.

Parturients undergoing traditional protocol continued the routine practice of admission a day prior to surgery, with scheduled preoperative counselling, overnight fasting, and liberal fluid administration along with use of povidone iodine as a standard antiseptic for all aseptic procedures. Standard practice of day 2 mobilization and delayed catheter removal was continued for them. In the ERAC protocol, parturients were counselled in detail on antenatal visit about risks and complications associated with the procedure and were also sensitized about the ERAC program and its benefits. After thorough understanding of the ERAC components and approval, parturients were asked to get admitted a day prior to surgery or on the day of surgery with advice to be followed at home for prior day. Alcohol-based chlorhexidine solution was used for asepsis except for vaginal toileting. Preoperative fasting was reduced to 2 hrs for clear liquids and carbohydrate rich drinks were given night before and on the day of surgery to avoid hypoglycaemia. Neuraxial anesthesia (SubArachnoid Block; SAB) was administered in both the protocols. In ERAC protocol, patients received fluid administration @15–20 ml/hr with continuous infusion of vasopressor to prevent hypotension intraoperatively and early feeding (within 2 hrs sips of water) early mobilization and decathterization within 6–10 hrs with multimodal analgesia to cover postoperative pain. Details of both protocols are given in https://links.lww.com/JOAC/A1 Annexure 1.

The aim of the study was to implement predefined ERAC protocol for better management of elective cesarean section patients and its comparison with existing traditional protocol to evaluate the barriers in its implementation in our institute. Primary outcome measured was comparison of total duration of stay (readiness to discharge) in the hospital between ERAC and traditional protocols. Parturients were considered ready for hospital discharge when there is tolerance of oral intake, recovery of lower gastrointestinal function, adequate pain control with oral analgesia, ability to mobilize and self-care, and no evidence of complications or untreated medical problem.[⁴]

Secondary objectives focused on intraoperative hemodynamic control (incidence of hypotension and bradycardia) and requirement of vasopressor, comparison of VAS scores and requirement of analgesics in 24 hrs, barriers to implementation of ERAC components, urinary retention, and need of recatheterization. Adverse events like nausea, vomiting, shivering, and respiratory depression were also noted.

If patient complained of any pain during surgery, Ketamine in the dose of 1 mg/kg and inj. midazolam 0.05 mg/kg was administered in incremental boluses till the desired effect was achieved in both the groups. All the parturients with failed spinal anesthesia were given general anesthesia and excluded from the study.

Data were recorded on a structured proforma and transferred to a Microsoft Excel database. Statistical Package for Social Sciences for Windows version 22 (SPSS Inc., Chicago, IL, USA) was used to perform statistical analysis. Mean ± standard deviation (SD) was used to represent the quantitative data, while frequency and percent were used to demonstrate qualitative data. Independent t-test, Chi-square test or Fisher's exact test were used to compare data between the two groups. P value of <0.05 was considered statistically significant.

Results

Total of 270 parturients were enrolled for the study. Out of them, 135 parturients were subjected to the traditional protocol for first six months and another 135 parturients were subjected to ERAC protocol for next six months. Out of 135 parturients in each group, 35 parturients were excluded from the study for various reasons and total of 100 parturients in each group were finally analyzed [Figure 1].

Figure 1: Consort flow chart

Both the groups were comparable regarding demographic characteristics [Table 1]. Length of stay or readiness for discharge from completion of cesarean delivery to discharge, showed a significant difference in both groups (Group A: 2.85 ± 0.5 vs Group B: 5.25 ± 0.61 hrs: P < 0.0001) [Table 2]. In Group A, 76% of the parturients were ready for discharge on 3^rd day; while in Group B, 72% were ready for discharge only by 5^th day.

Table 1: Comparison of demographic characteristics between the groups

Table 2: Readiness for discharge in two groups on different postoperative days

Baseline hemodynamic variables were comparable between the two groups. Patients in ERAC group reported significant fall in heart rate at various time intervals (p < 0.0001) after spinal anesthesia compared to traditional protocol.

Mean arterial pressure was found to be significantly lower in Group B (traditional protocol) at 2^nd (87.12 ± 0.85 vs 90.65 ± 9.11, P = 0.01), 4^th min (83.67 ± 0.04 vs 80.65 ± 8.01, P < 0.05), 6^th min (84.00 ± 2.44 vs 75.54 ± 8.92, P < 0.0001), and 8^th min (85.80 ± 13.78 vs 75.54 ± 8.92, P = 0.0001) after spinal anesthesia whereas it was comparable from 10^th min onward among the two groups. (p > 0.05).

The incidence of intra-operative hypotensive events was significantly greater in the traditional protocol group as also the requirement of boluses of phenylephrine. (p < 0.0001) Though total consumption of phenylephrine was more in Group A, as it was running as continuous infusion. [Table 3].

Table 3: Comparison of episodes of hypotension and bradycardia and total vasopressor dose requirement between the groups

Average VAS in the ERAC group was significantly lower than in traditional group up to 8 hrs postoperatively (p < 0.0001), while VAS scores from 12 to 24 hrs were not significantly different between the groups (p > 0.05). The total rescue analgesic (opioid) consumption was significantly less in the ERAC group when compared to traditional protocol group. (p < 0.0001) [Table 4].

Table 4: Comparison of Postoperative Rescue Analgesic (Tramadol- 100 mg) requirement

Though the pre-operative blood sugar level was found to be higher in the ERAC group (113.92 ± 13.80 vs 94.68 ± 9.36 mg, P < 0.0001) but there was no significant difference in postoperative blood sugar levels between the groups (p = 0.065).

Postoperative time of ambulation was significantly decreased in ERAC group (7.73 ± 1.80 vs 63.63 ± 6.76, P < 0.0001), as was time of urinary catheter removal (6.56 ± 1.00 vs 62.68 ± 9.71, P < 0.0001). Ninety two out of hundred parturients were successfully mobilized in 6–10 hrs after cesarean while decatheterization in 6–10 hrs was done in 98/100 parturients. The time of early feeding between the groups was found to be decreased in ERAC protocol group for Lozenges (2.35 ± 0.42 vs 0 hrs), liquids (4.18 ± 0.30 vs 16.09 ± 1.20 hrs), and semisolids (7.91 ± 0.75 vs 33.14 ± 4.97 hrs).

Initiation of breast feeding could not be implemented fully as most of the babies were not handed over to mother as per hospital neonatology protocols.

Discussion

Society for Obstetric Anesthesia and Perinatology (SOAP) has released consensus statement of recommendations in 2019 called as ERAC consensus statement which includes core recommended interventions needed to deliver ERAC.[⁵] On the other hand, ACOG and ERAS society provides guidelines for various aspect of clinical care to be included in ERAC.[⁶⁷⁸] The different components of ERAC with certain modifications have been implemented and assessed in different systematic reviews. Most of these studies and reviews come from the developed world, while their applicability in low resources countries like India, is very challenging.

Kleiman AM et al.[⁹] applied 12 out of 19 SOAP recommendations while studies done by Lester SA et al.[¹⁰] and Mullman L et al.[⁵] used 8 and 10 out of 19 SOAP recommendations, respectively, while in the present study 11 components have been implemented. In a systematic review of the studies comparing ERAC with standard care by Sultan P et al.[¹¹] large variation in protocols implemented and outcomes measured were found but the common denominator was inclusion of patient's education, pre- and post-delivery fasting time and use of multimodal analgesia.

In a review by Corso E et al.,[¹²] they identified 5 clinical protocols for ERAC with a total of 25 components. Three of the 25 components (early oral intake, mobilization, removal of the urinary catheter) were present in all 5 protocols. The five most common outcomes were post-operative complications, length of stay, process outcomes, survival, and functional outcomes.

In this study, a predefined ERAC protocol was implemented and compared with traditional care of cesarean section patients in the study institute. ERAC group initially underwent preoperative counselling about the procedure, pain score evaluation, and its management. Addressing the patient prior to anticipated event leads to alleviation of anxiety and reduction in intensity of pain and improving overall satisfaction.

Reduction in length of stay following implementation of ERAC is a widely studied parameter besides opioid consumption. ERAC protocols reduce LOS and cost savings without increasing adverse events such as 30-day readmission rates.[¹³] Though readmission rates were not observed in current study but Meng X et al.[¹⁴] conclude that implementation of ERAC does not increase the readmission rate, rather it decreases the readmission rate and also reduction in LOS reduces the hospital cost, incidence of complications, postoperative pain score, and opioid use. Early discharge not only represents faster recovery but also improves mother's bonding with child and overall satisfaction.[¹⁵] Most of the patients in ERAC group were ready to be discharged on 3^rd postoperative day. We considered readiness to discharge instead of actual day of discharge as maternal discharge in our country depends on many variables like neonatal health issues, health schemes guidelines, remuneration from insurance, preference of women to stay for longer time due to travel distance from their homes, etc., Lester SA et al.[¹⁰] also support our statement that length of stay mostly relates to health of neonates and they studied it as secondary outcome.

Sultan P et al.[¹¹] in their review found reduction in length of stay between ERAC and control groups in six of the seven studies. Two studies reported increased percentage of women discharged on day one following ERAC implementation.[¹⁶] Similarly Kleiman AM et al.[⁹] reported significant reduction in length of stay and also found higher percentage of women discharged prior to postoperative day (POD) 3. Studies[^1415171819] by other authors also found significant reduction in hospital stay after implementation of ERAC protocol. No significant difference in adverse effects were found between the two groups in our study as the traditional protocol in our institute covers the basic standards of care (anti-emetic prophylaxis, standard doses of anesthesia, analgesic coverage round the clock).

Carbohydrate pre-loading shows a positive impact on maternal anxiety and hunger. Reduction in fasting time and carbohydrate intake before surgery relieves the stress of hunger and anxiety before surgery and also reduces insulin resistance and loss of nutrition in postoperative period.[⁹¹¹] Carbohydrate-containing drinks consumed up to 2 hours prior to surgery may improve fetal glucose utilization and reduce maternal metabolic demand in comparison to traditional 8 hrs of fasting.[¹¹] In this study, all the patients in ERAC protocol received carbohydrate drink night before and 2 hrs prior to cesarean. Though preoperative blood sugar was found to be significantly more in ERAC group but no significant difference was found in post operative blood sugar level when compared to traditional protocol. Other studies[⁵⁹¹⁰¹⁷] have also included clear fluids with carbohydrate rich drink up to 2 hr before surgery, without any adverse effects.

Pain following cesarean results in increased overall morbidity as well as adversely affects care of newborn. ERAC core principles emphasizes on standardized and effective multimodal analgesia.[²⁰²¹] Multidimensional approach of analgesia with the goal of reducing pain perioperatively not only reduces suffering but also improves functional recovery with early return to daily activities.

We found significantly lower VAS scores in ERAC implemented group till 8 hrs after cesarean. This parameter of ERAC is implemented widely in most of the studies and significant reduction in VAS scores at various time intervals as well as opioid consumption was reported postoperatively. Similarly Meng X et al.[¹⁴] also found significant reduction in VAS score postoperatively in patient receiving ERAS than those receiving conventional care (WMD: 1.23, 95% CI: 1.32 to 1.15, P < 0.00001)

Peak pain scores were significantly less in ERAC group in the present study as also reported by Kleiman AM et al.,[⁹] Laronche et al.[²⁰] and Hedderson M et al.[²¹] They also reported reduced opioid consumption and improved pain score after implementation of ERAC protocol (acceptable pain scores increased from 82.1% to 86.4%, P < 0.001).

Early ambulation and early decatheterization decreases the incidence of venous thromboembolism and postoperative urinary tract infection. In this study we could implement these ERAC elements in almost all the parturients (ambulation in 92/100 and decatheterization 92/100) with no or minimal delay (avg 6–10 hrs). Similarly, Hedderson M et al.[²¹] saw reduction in postoperative mean time of ambulation after implementing ERAC protocol to the patients by 2.7 hrs (95% CI −3.1 to −2.4), and Lester SA et al.[¹⁰] also reported time to first ambulation as 9.76 hrs vs 32.89 hrs in ERAC and pre-ERAC groups, respectively. (P < 0.001)

Lester et al.[¹⁰] and Mazny et al.[²²] also concluded that mean post-operative ambulation time (p < 0.001) and length of hospital stay (p < 0.001) were significantly shorter without significant differences in incidence of urinary retention and recatheterization (p = 0.371) on early catheter removal.

Early oral intake not only hastens bowel function recovery but also improves maternal satisfaction, and helps in early mobilization and discharge without increasing complications such as nausea, vomiting, or infection. In this study initiation of early oral feed could be implemented on scheduled time in all the patients in ERAC protocol group (100/100) with no rise in incidence of nausea/vomiting or other gastrointestinal complication like abdominal distention. Similar to this study, Cattin et al.[¹⁸] also administered drinks at 1 h and first meal at 4 h postoperatively (52.6% vs 100%, P < 0.05 and 63.1% vs 100%, P < 0.005) when compared between before and after ERAS groups. Lester SA et al.[¹⁰] also observed significantly faster time to first oral intake after delivery for both clear liquids and solid food (2.2 hrs vs 3.6 hrs, P < 0.001 and 8.8 hrs vs 12.5 hrs, P < 0.001) when compared between enhanced and pre-enhanced recovery program groups.

Excellent analgesia, intra-operative warming, and early postoperative oral feeding all contribute to accelerating recovery by maintaining body homeostasis, early discharge, and reducing postoperative complications.[²³] Though we tried initiation of breast feeding within first hour of the CD but due to lack of cooperation from neonatology unit we could not follow up the effects of ERAC on neonates.

Limitations of the study

This was a single-center prospective comparative study with a relatively small sample size and the ERAS and traditional protocol groups were in different time frames, which may cause bias in the analysis. Patients admitted under different government schemes with limited funds and discharge policies, lack of equipped operation theatres for preventing temperature variations, limited manpower, and lack of cooperation from staff, all contributed toward challenges in implementation of ERAC protocol in toto.

An evaluation of quality of recovery through a structured scoring system would further enable us to highlight the advantages of implementing ERAC in all patients undergoing CD.

Conclusion

Implementation of ERAC, which is an evidence-based multidisciplinary approach through pre, intra and postoperative periods, results in significant reduction in length of stay in hospital with better postoperative pain relief and reduced opioid requirement for cesarean delivery. Our data add to the evidence supporting that part of ERAC protocols can be introduced for obstetric patient with a positive outcome, though challenges in implementation of complete ERAC protocol, do exist.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.