Studies to test effectiveness of pain medication for OB/GYN surgeries

GREENVILLE, N.C   (Dec. 20, 2001)   —   Two separate randomized studies within the Brody School of Medicine at East Carolina University are testing the effectiveness of pain medication for reducing post-operative pain from vaginal hysterectomies and Caesarean sections.

Dr. Paul Shackelford, associate professor of obstetrics and gynecology, is the lead investigator for the vaginal hysterectomy study evaluating the effectiveness of bupivacaine, a local anesthetic injected before surgery.

Dr. Paul Shackelford is one of several ECU physicians studying ways to reduce pain for OB/GYN patients. Photo by Cliff Hollis.

“Any surgeon is concerned with his or her patient’s post-operative pain,” Shackelford said. “There really isn’t much research literature that tells us whether or not using a local anesthetic such as bupivacaine ahead of time reduces a patient’s post-operative pain.”

Shackelford hopes to determine if using the injected drug with anesthesia lessens a patient’s need for narcotics after surgery. If the data supports its effectiveness, patients will be able to use other post-surgical pain medications that have fewer side effects than narcotics.

“Typically with a vaginal hysterectomy, patients go home within one to two days,” Shackelford said. “If using this drug allows them to be more comfortable and able to go home faster without the need for additional strong medication, then it’s better for the patient.”

Shackelford’s study will involve a random sample of 30 to 50 patients. Of these, some will receive bupivacaine and others a placebo. The drug or the placebo will be administered after anesthesia and before the surgery takes place. All patients in the study will receive the standard-of-care pain management treatment, he said.

Post-surgery patients will rate their pain level on a scale. Both private practice and medical school physicians have agreed to participate in the study, which began with one patient in late November. Shackelford hopes to recruit patients for the study starting this month with a projected study completion in the spring.

Assisting Shackelford is chief OB/GYN resident Dr. Melissa O’Neal and Dr. Todd Beste, who is also conducting a parallel post-operative pain study for Caesarean section deliveries. Shackelford and Beste hope their studies will produce sound data that could have widespread treatment implications locally and nationally in helping women receive adequate pain management.

Beste, ECU assistant professor of OB/GYN, is awaiting approval from the University Health Systems of Eastern Carolina Institutional Review Board and the federal Food and Drug Administration to proceed with his study of ketorolac. He plans to conduct a random, double-blind study of the medication. All study participants will receive the standard level of pain management, regardless of whether they receive ketorolac or a placebo.

Since ketorolac is a nonsteroidal anti-inflammatory drug, its side effects are minimal, Beste said. Patients who have a low tolerance for aspirin, have bleeding ulcers or experience stomach upset from taking NSAIDs may not be able to take the drug.

In Europe, ketorolac is routinely used for procedures such as Caesarean section, but Beste feels better data needs to be collected to determine if the drug is a good alternative for some patients. “There are a lot of questions that remain unanswered in regard to using ketorolac,” Beste said. “We hope this study will give us sound data so we can determine appropriate ways to help manage pain for our post-operative mothers.”

Candidates for the study will be non-breastfeeding women since the drug could be excreted in breast milk, according to the FDA. The American Academy of Pediatrics does not support this opinion, but the FDA still feels it is best to exclude women who plan to breastfeed, Beste said.

Beste hopes to recruit 90 patients for his study. Once he receives approval to proceed, the study should take six to nine months to complete.