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

Post Operative Pain (Post Laparoscopic Hernia Repair) Clinical Trial

Official title:

A Randomized, Double-blinded, Placebo-controlled Trial of the Effects of Infusing Local Anesthesia on Post-operative Pain During Laparoscopic Inguinal Hernia Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02055053
• Other study ID #: LCID 2013-031
• Status: Completed
• Phase: Phase 4
• Start date: August 2013
• Est. completion date: October 16, 2019

Study information

• Verified date: December 2021
• Source: Lahey Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 16, 2019
• Est. primary completion date: October 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Pain, Postoperative
• Post Operative Pain (Post Laparoscopic Hernia Repair)

Intervention

Drug:
• 0.5% Bupivicaine
Local anesthetic

Locations

Country	Name	City	State
United States	Lahey Hospital & Medical Center	Burlington	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Lahey Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale Pain Score Assessment (VAS)	Pain level at 4 hours after surgery VAS scale measures pain in whole numbers from 0 (no pain) to 10 (worst imaginable pain)	Post-operative period
Primary	Visual Analog Scale Pain Score Assessment (VAS)	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)	Pain scale 3 days after surgery
Secondary	Amount of Pain Medication Used in Oral Morphine Equivalents	Total mg of opiate after surgery	4 hours after surgery
Secondary	Duration of Narcotic Used to Control Pain	Number of days post-operatively narcotic is used	4 weeks post-op