Prospective randomized double-blind placebo-controlled trial of postoperative elastomeric pain pump devices used after laparoscopic ventral hernia repair.

BACKGROUND: The laparoscopic repair of ventral hernias can result in significant postoperative pain necessitating a prolonged hospital stay, increased narcotic use, and patient dissatisfaction. Elastomeric pain pump devices with local analgesics may significantly reduce postoperative discomfort after laparoscopic ventral hernia repair. This prospective randomized, double-blind, placebo-controlled study evaluated the effect of local anesthetic continuously infused with an elastomeric pain pump device to reduce postoperative pain.
METHODS: After institutional review board approval of the study, all patients undergoing laparoscopic ventral hernia repair consented to participate. Standardized technique included routine transfascial fixation sutures and titanium spiral tacks. Elastomeric pain pumps were placed percutaneously just above the mesh in the hernia sac. For 48 h postoperatively, 100 ml of continuous 0.5% Marcaine or normal saline was used at 2 ml/h. Postoperatively, the patients were evaluated every 8 h for the first 72 h, then after 2 weeks, 6 weeks, and 3 months for pain scores, narcotic usage (both oral and intravenous), return of flatus, length of hospital stay, and postoperative complications.
RESULTS: Of the 73 patients enrolled in the study, 37 received 0.5% Marcaine, and 36 received placebo. Despite randomization, the control group had significantly more obese patients (mean body mass index [BMI], 39 vs. 33 kg/m(2); p = 0.005), and more recurrent hernias (40% vs. 19%; p = 0.05), and also tended to have more prior hernia repairs (0.8 vs. 0.3; p = 0.06). There were no significant differences between the two groups in terms of operative times (p = 0.7), hernia size (p = 0.9), mesh size (p = 0.6), number of transfascial fixation sutures (p = 0.4), or number of spiral tacks (p = 0.13). Postoperative visual analog pain scores, usage of oral or intravenous narcotics, and morphine equivalents were similar between the two groups at all study points (p > 0.05). There were no significant differences between the two groups based on return of bowel function, toleration of a regular diet, or length of hospital stay. No postoperative complications directly related to the catheter were observed.
CONCLUSIONS: This prospective randomized double-blind, placebo-controlled trial showed no advantage of an elastomeric pain pump device in terms of providing a measurable reduction in postoperative pain scores, narcotic use, time to return of bowel function, or length of hospital stay after laparoscopic ventral hernia repair. Further studies are warranted to determine other alternatives for reducing postoperative pain after laparoscopic ventral hernia repair.

RCT Entities:   Population Interventions Outcomes