Skip to main content
OpenTrials
Completed

NCT Number: NCT07208253

Dexamethasone and Bupivacaine for Pain After Hernia Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Etlik City Hospital (Etlik Şehir Hastanesi)

Ankara, 06010, Turkey (Türkiye)

About this study

This randomized controlled study investigated the effect of adding dexamethasone to bupivacaine for pain management after laparoscopic total extraperitoneal (TEP) hernia repair. Postoperative pain is still a significant concern after TEP, even though this minimally invasive technique generally causes less pain than open surgery. Local anesthetics such as bupivacaine are widely used, but their effect is limited in duration. Dexamethasone, an anti-inflammatory corticosteroid, has been shown to enhance and prolong analgesia when combined with local anesthetics.

A total of 175 patients undergoing elective unilateral TEP hernioplasty were randomized into two groups. The intervention group received 20 mg of bupivacaine (4 mL of 0.5%) mixed with 8 mg dexamethasone, sprayed directly on the surgical mesh and surrounding tissues after mesh placement. The control group did not receive any local treatment in the operative field. All patients received standard postoperative analgesia.

Pain scores were assessed using the Visual Analog Scale (VAS) at 3, 6, and 12 hours after surgery. The need for additional analgesics, patient satisfaction, and early complications were also recorded.

Results showed that patients in the dexamethasone + bupivacaine group had significantly lower pain scores at all time points, required fewer additional analgesics, and reported higher satisfaction compared to controls. No increase in surgical complications was observed.

This study suggests that the local application of dexamethasone combined with bupivacaine is a safe, simple, and cost-effective method to improve early postoperative pain control and patient comfort after laparoscopic TEP hernia repair.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Postoperative Pain Scores

    Time frame: 12 hours after surgery

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

Secondary outcomes

  1. Additional Analgesic Requirement

    Time frame: 24 hours after surgery

    Number of patients requiring supplemental analgesics during the first 24 hours after surgery.

  2. Patient Satisfaction

    Time frame: Within 24 hours after surgery

    Patient-reported satisfaction with pain management, scored on a 4-point Likert scale (poor, moderate, good, excellent).

  3. Postoperative Complications

    Time frame: Within 30 days after surgery

    Frequency of early complications such as hematoma, urinary retention, wound infection.

Sponsors and collaborators

Lead sponsor

Gürkan Değirmencioğlu

Other Gov

Registry information

Official study title

Effect of Dexamethasone and Bupivacaine on Postoperative Pain Following Total Extraperitoneal Hernioplasty: A Randomized Controlled Prospective Study

Acronym: DEXA-BUPI

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Oct 6, 2025
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.