This study is comparing two ways to manage pain after a major hernia repair surgery called "transversus abdominis release." One method uses an epidural, a small tube placed in the back that delivers pain medicine directly around the spine. The other method avoids the epidural and instead uses a combination of non-opioid pain medicines, along with an injection of numbing medicine into the abdominal wall during surgery. Patients who still have pain that is hard to control with either method will be given rescue pain medicine through an intravenous (IV) pump. Researchers want to learn which method controls pain better and results in patients using fewer opioid pain medicines after surgery. Participants will be randomly assigned (like a coin flip) to one of the two pain control methods. Pain levels and medication use will be tracked during the hospital stay, and participants will be contacted 30 days after surgery to check on recovery and any side effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
Local anesthetic administered via thoracic epidural catheter, both as an intraoperative bolus and as part of a standardized postoperative continuous infusion combined with fentanyl, discontinued on postoperative day 3.
Opioid administered via continuous thoracic epidural infusion in combination with bupivacaine during the postoperative period, discontinued on postoperative day 3.
Catheter placed preoperatively in the thoracic epidural space to enable intraoperative and postoperative delivery of local anesthetic and opioid analgesia.
Opioid administered intravenously via patient-controlled analgesia (PCA) as rescue therapy for participants in either study arm who have inadequate pain control with their assigned analgesia protocol.
Administered intraoperatively (intravenous) and on a scheduled postoperative basis as part of the opioid-sparing multimodal analgesia protocol.
Nonsteroidal anti-inflammatory drug administered intraoperatively (intravenous) and on a scheduled postoperative basis as part of the opioid-sparing multimodal analgesia protocol.
Administered intraoperatively (intravenous) as part of the opioid-sparing multimodal analgesia protocol.
Opioid-like analgesic administered on a scheduled postoperative basis (oral) as part of the opioid-sparing multimodal analgesia protocol.
Anticonvulsant used for adjunct analgesia, administered on a scheduled postoperative basis (oral) as part of the opioid-sparing multimodal analgesia protocol.
Muscle relaxant administered on a scheduled postoperative basis (oral) as part of the opioid-sparing multimodal analgesia protocol.
Regional anesthetic technique performed intraoperatively by the surgeon, injecting local anesthetic into the transversus abdominis plane of the abdominal wall, as part of the opioid-sparing multimodal analgesia protocol.
Northwestern Memorial Hospital
Chicago, Illinois, United States
RECRUITINGArea Under the Curve (AUC) of Postoperative Pain Scores
Postoperative pain will be measured using the Numeric Rating Scale (NRS, 0-10) at standardized 6-hour intervals over the first four postoperative days. The area under the curve of these serial measurements will be calculated to reflect cumulative postoperative pain burden.
Time frame: Postoperative Day 1 through Postoperative Day 4
Total Postoperative Opioid Consumption
Total opioid consumption during hospitalization, measured in oral morphine milligram equivalents (MME). For patients receiving epidural analgesia, neuraxial opioid use will be quantified and reported separately from oral/intravenous MME.
Time frame: Through hospital discharge, an average of 5 days
Length of Hospital Stay
Total number of days from surgery to hospital discharge.
Time frame: Through hospital discharge, an average of 5 days
Incidence of Postoperative Ileus
Postoperative ileus, defined as the requirement for nasogastric tube decompression.
Time frame: Through hospital discharge, an average of 5 days
Incidence of Epidural-Related Complications
Hypotension (defined as a drop in systolic blood pressure or mean arterial pressure of more than 20% from baseline) and urinary retention requiring Foley catheter reinsertion.
Time frame: Through hospital discharge, an average of 5 days
Patient Satisfaction with Pain Management (Binary)
Patient satisfaction with postoperative pain management, assessed prior to discharge using a binary (yes/no) question.
Time frame: At hospital discharge
30-Day Postoperative Complications
Incidence of wound complications, respiratory complications, hospital readmission, reoperation, and hernia recurrence, assessed as part of standard of care data collection.
Time frame: 30 days (± 15 days) postoperatively
30-Day Postoperative Opioid Prescribing and Consumption
Number and dose of opioids prescribed, and total opioids consumed, in the 30 days following surgery
Time frame: 30 days (± 15 days) postoperatively
Patient Satisfaction with Pain Management (Numeric Scale)
Patient satisfaction with postoperative pain management, assessed prior to discharge using a 1-10 numeric satisfaction scale, with higher scores indicating greater satisfaction.
Time frame: At hospital discharge
Daily Average Numeric Rating Scale Pain Score
Average Numeric Rating Scale (NRS) pain score calculated for each of the first four postoperative days, on a scale of 1-10, with 0 meaning no pain and 10 being the worst pain imaginable
Time frame: Postoperative Day 1 through Postoperative Day 4
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