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Epidural Analgesia Versus Opioid-sparing Analgesia for Open Ventral Hernia Repair With Transversus Abdominis Release

ConditionsVentral HerniaVentral Hernia RepairPostoperative Pain
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNorthwestern University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female patients ≥18 years old

Symptomatic incisional ventral or parastomal hernias

Planned transversus abdominis release

Ability to provide informed consent

Disqualifiers

Contraindications to epidural placement

Chronic pre-operative opioid use, defined as daily opioid use for 30-days prior to surgery

Allergy or intolerance to study medications

Age greater than 80 years

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bupivicaine

    Drug

    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.

  • Fentanyl

    Drug

    Opioid administered via continuous thoracic epidural infusion in combination with bupivacaine during the postoperative period, discontinued on postoperative day 3.

  • Thoracic epidural analgesia

    Device

    Catheter placed preoperatively in the thoracic epidural space to enable intraoperative and postoperative delivery of local anesthetic and opioid analgesia.

  • Hydromorphone

    Drug

    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.

  • Acetaminophen

    Drug

    Administered intraoperatively (intravenous) and on a scheduled postoperative basis as part of the opioid-sparing multimodal analgesia protocol.

  • Ketorolac

    Drug

    Nonsteroidal anti-inflammatory drug administered intraoperatively (intravenous) and on a scheduled postoperative basis as part of the opioid-sparing multimodal analgesia protocol.

  • magnesium sulfate

    Drug

    Administered intraoperatively (intravenous) as part of the opioid-sparing multimodal analgesia protocol.

  • Tramadol

    Drug

    Opioid-like analgesic administered on a scheduled postoperative basis (oral) as part of the opioid-sparing multimodal analgesia protocol.

  • Gabapentin

    Drug

    Anticonvulsant used for adjunct analgesia, administered on a scheduled postoperative basis (oral) as part of the opioid-sparing multimodal analgesia protocol.

  • Cyclobenzaprine

    Drug

    Muscle relaxant administered on a scheduled postoperative basis (oral) as part of the opioid-sparing multimodal analgesia protocol.

  • transversus abdominis plane block

    Procedure/Surgery

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Epidural AnalgesiaActive comparator 4 interventions
Group B: Opioid-Sparing Multimodal AnalgesiaExperimental treatment 8 interventions

Trial outcomes

Primary outcomes

1

Area 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

Secondary outcomes

1

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
2

Length of Hospital Stay

Total number of days from surgery to hospital discharge.

Time frame
Through hospital discharge, an average of 5 days
3

Incidence of Postoperative Ileus

Postoperative ileus, defined as the requirement for nasogastric tube decompression.

Time frame
Through hospital discharge, an average of 5 days
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

Source ClinicalTrials.gov
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