Spinal Analgesia Versus No Analgesia: Study for External Cephalic Version
Summary
The purpose of this study is to examine whether spinal anesthesia affects the chances of successful external cephalic version (ECV) of a breech presenting fetus. Two study groups will be included; one will receive spinal anesthesia, the other will not. The non-spinal group will be permitted to cross over if ECV procedure is painful. The main outcome is success of ECV.
Timeline
- Start
- 2002-10
- Primary completion
- 2006-03
- Completion
- 2008-05
Outcome
Met primary endpoint
Stopped (Enrollment): “Multiparas study terminated due to poor recruitment. Randomization revealed only after decision recorded on clinicaltrials.gov”
paper 27 of 31 patients (87.1%) receiving spinal analgesia vs 19 of 33 (57.5%) with no analgesia (P=0.009) PMID 20338954 ↗
paper Successful external cephalic version occurred among 24 of 36 (66.7%) women randomized to receive spinal analgesia compared with 11 of 34 (32.4%) without, P=.004 PMID 18055730 ↗
Publications
- Weiniger CF, Ginosar Y, Elchalal U, Sela HY, Weissman C, Ezra Y. Randomized controlled trial of external cephalic version in term multiparae with or without spinal analgesia. Br J Anaesth. 2010 May;104(5):613-8. doi: 10.1093/bja/aeq053. Epub 2010 Mar 25.
- Weiniger CF, Ginosar Y, Elchalal U, Sharon E, Nokrian M, Ezra Y. External cephalic version for breech presentation with or without spinal analgesia in nulliparous women at term: a randomized controlled trial. Obstet Gynecol. 2007 Dec;110(6):1343-50. doi: 10.1097/01.AOG.0000295605.38175.7b.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupivacaine | Other / unclassified | 7.5 mg | Intrathecal |
Indications
No indication recorded.