Pain Scores During Transcervical Procedures Under Paracervical Block, the Value of Prior Cervical Ripening by Vaginal Misoprostol; A Double-Blind, Placebo-Controlled Trial
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Pain Scores During Transcervical Procedures Under Paracervical Block, the Value of Prior Cervical Ripening by Vaginal Misoprostol; A Double-Blind, Placebo-Controlled Trial,ALI M. EL SAMAN, MOHAMAD G. ABDEL RAHEEM, ABD EL RADY SHEHATA I. and SAHAR N. ABD EL SAMED
Abstract
Purpose: To evaluate the intra-operative course (including pain scores) of transcervical procedures under paracervical block, with or without vaginal misoprostol as a cervical ripening agent.
Study design: This is a randomized double-blind placebo-controlled study. The patients were randomly allocated, by means of computer-generated numbers, to receive either placebo or 200 mg of misoprostol 24 and 12 hours before surgery.
Setting: Department of Obstetrics and Gynecology, Assiut University Hospital, Assiut, Egypt.
Subjects: One hundred forty five cases with any indications for cervical dilatation up to 8-mm or more were considered eligible for the trial, 23 refused to be operated under paracer-vical block and 20 cases didn’t completed the protocol. The remaining 102 cases were randomly allocated either for misoprostol (51 cases) or placebo (51 cases).
Outcome measures: The primary outcome measure was intraoperative pain scores as measured by visual analog scale (VAS). The secondary outcome measure in this study was the ease of cervical dilatation. To avoid subjective bias, the ease of cervical dilatation was converted to an objectively measur-able and statistically manageable variable by development of a simplified 8-points scale for scoring the ease of cervical dilatation. Also the needs for conversion to general anesthesia and side effects were also reported.
Results: Pain scores were significantly lower in misopros-tol group compared to placebo group during cervical dilatation (p=0.027, CI-10.5: -0.6). However the difference was less obvious during the definitive transcervical procedure. Also cervical dilatation scores were significantly lower (1.7±1 Vs. 4.9±0.9) in misoprostol group than they were in the placebo group (CI-2.4: -1.7 p=.001).
Dilatation time, as well as the number of cases needed conversion to general anesthesia were significantly less in the study group, however there were no differences in the complication rates.
Conclusions: The use of vaginal misoprostol as a cervical ripening agent was found to be associated with lower pain scores in cases undergone transcervical procedures under paracervical block than was the use of placebo. Also it was found to be associated with lower cervical dilatation scores (easier cervical dilatation), consequently, fewer cases needed conversion to general anesthesia.