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

NCT07840183 | Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: STU00225786
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ventral Hernia; Ventral Hernia Repair; Postoperative Pain

Keywords

ventral hernia; complex abdominal wall hernia; ventral hernia repair; postoperative pain control

Outcome Measures

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.

  Postoperative Day 1 through Postoperative Day 4

Secondary Outcomes (9)

• Total Postoperative Opioid Consumption

  Through hospital discharge, an average of 5 days

• Length of Hospital Stay

  Through hospital discharge, an average of 5 days

• Incidence of Postoperative Ileus

  Through hospital discharge, an average of 5 days

• Incidence of Epidural-Related Complications

  Through hospital discharge, an average of 5 days

• Patient Satisfaction with Pain Management (Binary)

  At hospital discharge

Study Arms (2)

Epidural Analgesia

ACTIVE COMPARATOR

Patients will receive a preoperative thoracic epidural catheter with intraoperative bupivacaine dosing and a standardized postoperative bupivacaine/fentanyl infusion, discontinued on postoperative day 3. Patients will not receive IV acetaminophen or IV ketorolac but will receive other standard multimodal agents. Patients requiring rescue analgesia will be transitioned to bupivacaine-only epidural dosing and IV hydromorphone PCA as needed.

Drug: Bupivicaine; Drug: Fentanyl; Device: Thoracic epidural analgesia; Drug: Hydromorphone

Opioid-Sparing Multimodal Analgesia

EXPERIMENTAL

Patients will receive intraoperative IV acetaminophen, ketorolac, magnesium sulfate, and a surgeon-administered transversus abdominis plane block, followed by scheduled postoperative multimodal analgesia (acetaminophen, ketorolac, tramadol, gabapentin, cyclobenzaprine) and an ice pack. IV hydromorphone will be used only as rescue therapy for inadequate pain control.

Drug: Hydromorphone; Drug: Acetaminophen; Drug: Ketorolac; Drug: magnesium sulfate; Drug: Tramadol; Drug: Gabapentin; Drug: Cyclobenzaprine; Procedure: transversus abdominis plane block

Interventions

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.

Epidural Analgesia

Fentanyl DRUG

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

Epidural Analgesia

Thoracic epidural analgesia DEVICE

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

Also known as: Epidural catheter

Epidural 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.

Also known as: dilaudid

Epidural Analgesia; Opioid-Sparing Multimodal Analgesia

Acetaminophen DRUG

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

Also known as: tylenol, Paracetamol

Opioid-Sparing Multimodal Analgesia

Ketorolac DRUG

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

Also known as: toradol

Opioid-Sparing Multimodal Analgesia

magnesium sulfate DRUG

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

Opioid-Sparing Multimodal Analgesia

Tramadol DRUG

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

Also known as: ultram

Opioid-Sparing Multimodal Analgesia

Gabapentin DRUG

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

Opioid-Sparing Multimodal Analgesia

Cyclobenzaprine DRUG

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

Also known as: Flexeril

Opioid-Sparing Multimodal Analgesia

transversus abdominis plane block PROCEDURE

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.

Also known as: TAP block

Opioid-Sparing Multimodal Analgesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients ≥18 years old
• Symptomatic incisional ventral or parastomal hernias
• Planned transversus abdominis release
• Ability to provide informed consent

You may not qualify if:

• 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
• Impaired renal function - defined as creatinine clearance or estimated GFR of \<60ml/min
• Planned ICU admissions with post-operative intubation
• Urgent or emergent presentations
• Adults unable to consent
• Pregnant patients

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (2)

• Morrell DJ, Doble JA, Hendriksen BS, Horne CM, Hollenbeak CS, Pauli EM. Comparative effectiveness of surgeon-performed transversus abdominis plane blocks and epidural catheters following open hernia repair with transversus abdominis release. Hernia. 2021 Dec;25(6):1611-1620. doi: 10.1007/s10029-021-02454-0. Epub 2021 Jul 28.

  PMID: 34319465 BACKGROUND

• Melland-Smith M, Zheng X, Messer N, Beffa L, Petro C, Prabhu A, Krpata D, Rosen M, Miller B. Epidural analgesia and post-operative ileus after incisional hernia repair with transversus abdominis release: Results of a 5-year quality improvement initiative. Am J Surg. 2024 Apr;230:30-34. doi: 10.1016/j.amjsurg.2023.11.009. Epub 2023 Nov 11.

  PMID: 38000938 BACKGROUND

MeSH Terms

Conditions

Hernia, Ventral; Pain, Postoperative

Interventions

Fentanyl; Hydromorphone; Acetaminophen; Ketorolac; Ketorolac Tromethamine; Magnesium Sulfate; Tramadol; Gabapentin; cyclobenzaprine

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Nancy Ly, MD

CONTACT

3126956868; nancy.ly@nm.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 24, 2026
• Study Start: September 18, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)