Dexamethasone and Bupivacaine for Pain After Hernia Surgery

NCT ID: NCT07208253

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2023-01-15

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.

Detailed Description

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.

Conditions

Inguinal Hernia Repair (Not Urgent)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental: Intervention Group

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.

Group Type: EXPERIMENTAL

Bupivacaine + Dexamethasone

Intervention Type: 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.

No Intervention: Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bupivacaine + Dexamethasone

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gürkan Değirmencioğlu

OTHER_GOV

Sponsor Role: lead

Responsible Party

Gürkan Değirmencioğlu

General Surgery Specialist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

GÜRKAN DEĞİRMENCİOĞLU, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Etlik City Hospital (Etlik Şehir Hastanesi)

Ankara, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2021/26

Identifier Type: OTHER

Identifier Source: secondary_id

EŞH-GC-2025-01

Identifier Type: -

Identifier Source: org_study_id