AT SGS 2017
SAN ANTONIO (FRONTLINE MEDICAL NEWS) – Liposomal bupivacaine reduced pain after midurethral sling surgery, compared with placebo in a randomized trial, but because of its cost it may be best to keep it in reserve for women who can’t, or shouldn’t, take opioids, said lead investigator Donna Mazloomdoost, MD, a gynecologic surgeon at Good Samaritan Hospital, Cincinnati.
Fifty-four women were randomized to receive liposomal bupivacaine (Exparel) injected into the two trocar paths and the vaginal incision at the end of the procedure; 55 others were injected with normal saline as a placebo.
Pain scores, assessed by diary, were slightly lower in the liposomal bupivacaine group 4 hours after discharge home on a 100-mm visual analogue scale (3.5 mm versus 13 mm, P = .014). VAS scores were also a bit lower for the liposomal bupivacaine group on postop day 1 (9.5 mm versus 27 mm, P = .014), postop day 2 (5.5 mm versus 10 mm, P = .027), and postop day 3 (4 mm versus 7 mm, P = .043).
Fewer women in the liposomal bupivacaine group took narcotics on postop day 2 (12 versus 27, P = .006). However, there was no difference in overall satisfaction with pain control at 1 and 2 weeks follow-up.
Even so, “for this common outpatient surgery, liposomal bupivacaine may be a beneficial addition for pain control,” the investigators concluded.
Liposomal bupivacaine is a local anesthetic with slow release over 72 hours, approved for treatment of postsurgical pain in 2011. “The cost is about $300 at our institution; the charge to the patient is about $1,000,” Dr. Mazloomdoost said at the annual scientific meeting of the Society of Gynecologic Surgeons jointly sponsored by the American College of Surgeons.
Because of the expense, liposomal bupivacaine is restricted in many hospitals, and gynecologic surgeons are trying to figure out what role it has, if any, in low-pain outpatient procedures like midurethral slings.
“I don’t know if you can justify” routine use for low-pain procedures, “but if you are concerned about opioid” use after surgery – intolerance or addiction – “I would use this,” Dr. Mazloomdoost said.
The investigators expanded 20 mL of liposomal bupivacaine with 10 mL of normal saline for a total of 30 mL. It was split evenly between the two trocar sites and the vaginal epithelium; 10 mL was injected in each of the three sites shortly before the intervention women were roused from anesthesia. The needle was inserted as deeply as possible, and liposomal bupivacaine was injected as the needle was drawn back. Because of the viscosity, it takes at least a 25-gauge needle.
Surgeons knew that they were injecting liposomal bupivacaine instead of saline because of the thickness and color, but they weren’t the ones collecting data, and the women were blinded to the treatment.
Patients were a mean age of 52 years. The mean body mass index was 29.2 kg/m2 in the liposomal bupivacaine group, and 31.6 kg/m2 in the placebo group; there were otherwise no significant demographic differences. Fifty-two women in the liposomal bupivacaine group received midazolam during anesthesia induction versus 44 women receiving placebo, but there were no significant differences in operating time or the number of women in each group who had concomitant anterior or urethrocele repairs, and no differences in urinary retention, time to first bowel movement – about 2 days – or adverse events. The most common adverse events in both groups were nausea/vomiting, headache, and itching.
Women in both groups received intravenous acetaminophen before anesthesia induction, and ketorolac before leaving the operating room; 10 mL of lidocaine with epinephrine was injected into the trocar paths and vaginal epithelium prior to the first incision.
The investigators reported having no relevant financial disclosures.