Objective To evaluate two methods of pain relief during postpartum surgical repair in regard to effectiveness, wound healing and patient evaluation. Design A randomised controlled trial testing a pragmatic set-up of brief training of clinicians. Setting Delivery ward at a Danish district hospital with approximately 1600 annual deliveries. Population Primiparous women with a vaginal delivery at term who needed surgical repair of lacerations to the labia or the vagina, perineal lacerations of first or second degree or mediolateral episiotomies. Methods The trial was set up to evaluate the effect of a brief 2-hour hands-on training in the use of ear acupuncture. All midwives (n= 36) in the department had previous experience in using acupuncture for obstetric pain relief. Pain and wound healing were evaluated using validated scores. Data collection was performed by research assistants blinded towards treatment allocation. Randomisation was computer assisted. A total of 207 women were randomised to receive ear acupuncture (105) and local anaesthetics (102), respectively. Main outcome measures The primary outcome was pain during surgical repair. Secondary outcomes were wound healing at 24-48 hours and 14 days postpartum, participant satisfaction, revision of wound or dyspareunia reported 6 months postpartum. Results Pain during surgical repair was more frequently reported by participants allocated to ear acupuncture compared with participants receiving local anaesthetics (89 versus 54%, P < 0.01). Pain intensity during surgical repair was also reported higher (Visual Analogue Scale score 3.5 versus 1.5, P < 0.01). The ear acupuncture group received more additional pain relief during repair (53 versus 19%, P < 0.01). No difference was observed in wound healing at 24-48 hours or 14 days postpartum. Revision of wounds was rare, and no difference occurred in this trial. Comparable proportions of participants reported dyspareunia at 6 months. Patient satisfaction with the allocated pain-relief method was lower in the ear acupuncture group (69 versus 91%, P < 0.01) and fewer women would recommend the method to a friend (74 versus 91%, P < 0.01). Conclusions Ear acupuncture as used in this trial was less effective for pain relief compared with a local anaesthetic. No difference was observed in wound healing, need for revision of wound or dyspareunia. Patient satisfaction with allocated pain-relief method was lower in the ear acupuncture group.
British Journal of Obstetrics and Gynecology, 2009, Vol 116, Issue 4, p. 569-76