Randomized Controlled Study Comparing Epidural Versus Intravenous Opioid Administration for Post-Operative Pain Relief in Laparotomy Patients

What this Trial Is About

Researchers are comparing two common methods of giving additional opioid pain medicine to patients having open upper abdominal surgery with an epidural. The study aims to find out if mixing opioids with the epidural solution or giving opioids separately through an intravenous pump works equally well for controlling pain after surgery. This randomized controlled trial includes adults aged 18 to 85 who are expected to use an epidural for about 4 to 5 days after surgery. Participants will be randomly assigned to one of two groups. One group will receive hydromorphone (an opioid) through an intravenous patient-controlled analgesia (PCA) pump combined with a continuous epidural infusion of local anesthetic. The other group will receive hydromorphone mixed with local anesthetic continuously through the epidural, with the option to control additional doses via a patient-controlled epidural analgesia (PCEA) pump. The epidural and intravenous pumps will be covered to keep patients and observers blinded to the treatment. During the study, patients will be visited daily to assess pain levels and satisfaction using the Quality of Recovery 15 questionnaire. Researchers will also monitor side effects, ability to move, return of bowel function, need for extra oxygen, and total opioid usage. Data will be kept confidential under a study number. The main outcome is pain control up to one day after epidural removal, with follow-up up to 8 days post-operation. Secondary outcomes include side effect rates, bowel function recovery, and discharge timing, tracked for up to 7 to 10 days after surgery.

IV vs Epidural Opioids + Epidural Local Anesthetic for Laparotomy Analgesia