Effects of Local Anesthesia on Post-operative Pain During Laparoscopic Inguinal Hernia Repair

Phase 4

Completed

• Conditions: Post Operative Pain (Post Laparoscopic Hernia Repair)
• Interventions: Drug: 0.5% Bupivicaine

• Registration Number: NCT02055053
• Lead Sponsor: Lahey Clinic

Brief Summary

To assess effect of local anesthetic into the preperitoneal space during laparoscopic hernia repair on post-operative pain.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-02-03
• Study First Submitted QC: 2014-02-03
• Study First Posted: 2014-02-04
• Primary Completion: 2019-10-16
• Study Completion: 2019-10-16
• Results First Submitted: 2020-10-07
• Results First Submitted QC: 2020-11-18
• Results First Posted: 2020-12-14
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-20
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Age 18 or older with unilateral or bilateral inguinal herna for laparoscopic repair
• American Society of Anesthesiology (ASA) Class I and II

Exclusion Criteria

• Conversion from laparoscopic to open surgery
• History of Chronic pain or ongoing treatment for chronic pain
• Age less than 18 yrs
• Allergy to local anesthetics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anesthetic intervention	0.5% Bupivicaine	After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the treatment group will receive infusion of 15 cc 0.5% Bupivicaine.
Saline intervention	0.5% Bupivicaine	After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the placebo group will receive the infusion of 15 cc 0.9% Saline.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale Pain Score Assessment (VAS)	Pain scale 3 days after surgery	Pain level recorded at 3 days after surgery. VAS scale measures pain in increments of whole numbers from 0 (no pain) to 10 (most sever pain imaginable)

Secondary Outcome Measures

Name	Time	Method
Amount of Pain Medication Used in Oral Morphine Equivalents	4 hours after surgery	Total mg of opiate after surgery
Duration of Narcotic Used to Control Pain	4 weeks post-op	Number of days post-operatively narcotic is used

Trial Locations

Locations (1)

Lahey Hospital & Medical Center; 🇺🇸 Burlington, Massachusetts, United States