OBJECTIVE: To estimate the effectiveness of paracervical block in controlling pain among women treated with manual vacuum aspiration for an incomplete abortion
METHODS: A randomized clinical trial was conducted at Nuestra Señora de Altagracia, a maternal and perinatal referral hospital in the Dominican Republic. The sample size was based on a clinical difference of 1.5 points in the level of pain measured with the visual analog scale using 90% power and a sampling error of 0.04. Women who were at 12 weeks of gestation or less with an incomplete abortion were eligible to participate. They were randomly assigned to receive either the standard treatment of care (manual vacuum aspiration for uterine evacuation with psychological support but no paracervical block) or manual vacuum aspiration treatment with psychological support and paracervical block using 1.0% lidocaine. Patients with active infections, severe illnesses, psychiatric disorders, or allergies to lidocaine were excluded. Intraoperative pain as reported by the women and as documented by an external observer was measured.
RESULTS: Although the paracervical block technique used showed a slight reduction in severe pain, there were no clinically or statistically significant differences in intraoperative pain between the 2 groups (relative risk 0.73; 95% confidence interval 0.43, 1.23) with 50% of all patients registering 7 or higher score on a visual analog pain scale of 0–10. However, statistically significant differences were found in each group when comparing the level of preoperative and intraoperative pain described by the patient (P < .001). The manual vacuum aspiration technique and the paracervical block were not accompanied by complications.
CONCLUSION: The paracervical block technique used in this study along with psychological support was comparable with pain control using psychological support alone; neither pain management regimen provided sufficient pain control. It is recommended that randomized comparative studies be designed to determine the effectiveness of other paracervical block techniques and the efficacy of the use of analgesics in patients suffering from incomplete abortion treated with manual vacuum aspiration.
LEVEL OF EVIDENCE: I
Paracervical block with psychological support given to patients for the management of pain is comparable to management of pain using only psychological support; neither regimen supplies sufficient management of pain during manual vacuum aspiration.
From the *Obstetrics and Gynecology Department and †Clinical Research Institute, Universidad Nacional de Colombia—International Clinical Epidemiology Network (INCLEN), Bogotá, Columbia; ‡EngenderHealth, New York, New York; and §Hospital Nuestra Señora de la Altagracia, Santo Domingo, Dominican Republic.
Supported by the David and Lucille Packard Foundation.
This study was performed at the Hospital Nuestra Señora de la Altagracia, Santo Domingo, Dominican Republic, 2002.
Address reprint requests to: Pio Iván Gómez, Clinical Research Institute, Universidad Nacional de Colombia, Instituto Materno Infantil, Carrera 10# 1–66 sur. Bogotá, Colombia; e-mail: email@example.com.
Received September 22, 2003. Received in revised form December 23, 2003. Accepted February 2, 2004.