Dexamethasone and Bupivacaine for Pain After Hernia Surgery

NCT07208253 | Completed

• 2 other identifiers: EŞH-GC-2025-012021/26
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

This study looked at whether a combination of two medicines, dexamethasone and bupivacaine, can reduce pain after laparoscopic hernia surgery. A total of 175 patients who had elective total extraperitoneal (TEP) hernia repair were randomly assigned to two groups. One group received a spray of dexamethasone and bupivacaine around the surgical mesh, while the other group did not receive any local treatment. Pain levels were measured at 3, 6, and 12 hours after surgery using a visual pain scale. The need for additional pain medicine and patient satisfaction were also recorded. Patients who received dexamethasone and bupivacaine reported lower pain scores, needed less extra pain medicine, and were more satisfied with their pain control compared to the control group. The results suggest that this simple, safe, and low-cost method may help improve pain control and comfort after laparoscopic hernia repair.

Conditions

Inguinal Hernia Repair (Not Urgent)

Keywords

Inguinal Hernia, Total Extraperitoneal Hernioplasty (TEP), Postoperative Pain, Dexamethasone, Bupivacaine, Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Scores

  Pain intensity measured using the Visual Analog Scale (VAS) at 3, 6, and 12 hours after surgery.

  12 hours after surgery

Secondary Outcomes (3)

• Additional Analgesic Requirement

  24 hours after surgery

• Patient Satisfaction

  Within 24 hours after surgery

• Postoperative Complications

  Within 30 days after surgery

Study Arms (2)

Experimental: Intervention Group

EXPERIMENTAL

Patients received 20 mg bupivacaine (4 mL of 0.5%) combined with 8 mg dexamethasone. The solution was sprayed over the mesh and surrounding tissues after mesh placement during laparoscopic total extraperitoneal (TEP) hernioplasty.

Drug: Bupivacaine + Dexamethasone

No Intervention: Control Group

NO INTERVENTION

Patients underwent standard laparoscopic total extraperitoneal (TEP) hernioplasty without local application of bupivacaine or dexamethasone in the operative field.

Interventions

Bupivacaine + Dexamethasone DRUG

20 mg bupivacaine (4 mL of 0.5%) combined with 8 mg dexamethasone, sprayed locally over the mesh and surrounding tissues after placement during laparoscopic TEP hernioplasty.

Experimental: Intervention Group

Eligibility Criteria

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

You may qualify if:

• Adults (≥18 years old) scheduled for elective unilateral inguinal hernia repair with the laparoscopic total extraperitoneal (TEP) technique
• American Society of Anesthesiologists (ASA) physical status I-II
• Ability to provide informed consent

You may not qualify if:

• Age \<18 years
• ASA physical status ≥III
• Recurrent or bilateral inguinal hernia
• History of allergy to local anesthetics or corticosteroids
• Chronic opioid use or dependence
• Severe hepatic, renal, or cardiac disease
• Pregnancy or breastfeeding
• Patients who declined to participate or could not provide consent

Sponsors & Collaborators

• Gürkan Değirmencioğlu: lead

Study Sites (1)

Etlik City Hospital (Etlik Şehir Hastanesi)

Ankara, Ankara, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hernia, Inguinal; Pain, Postoperative

Interventions

Bupivacaine; Dexamethasone

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)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• GÜRKAN DEĞİRMENCİOĞLU, MD

  Etlik City Hospital, Department of General Surgery, Ankara,Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Pain scores were assessed by an independent health care provider who was blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: General Surgery Specialist

Model Details: Randomized, two-arm, parallel assignment study comparing dexamethasone plus bupivacaine versus no local treatment in patients undergoing elective unilateral laparoscopic total extraperitoneal (TEP) hernioplasty.

Study Record Dates

• First Submitted: September 27, 2025
• First Posted: October 6, 2025
• Study Start: April 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: January 15, 2023
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)