Back to resultsEffects of Local Anesthesia on Post-operative Pain During Laparoscopic Inguinal Hernia Repair
Primary Purpose
Post Operative Pain (Post Laparoscopic Hernia Repair)
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
0.5% Bupivicaine
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain (Post Laparoscopic Hernia Repair) focused on measuring Post Operative Pain, hernia repair
Eligibility Criteria
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
Sites / Locations
- Lahey Hospital & Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
anesthetic intervention
Saline intervention
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
Amount of Pain Medication Used in Oral Morphine Equivalents
Total mg of opiate after surgery
Duration of Narcotic Used to Control Pain
Number of days post-operatively narcotic is used
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02055053
Brief Title
Effects of Local Anesthesia on Post-operative Pain During Laparoscopic Inguinal Hernia Repair
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
October 16, 2019 (Actual)
Study Completion Date
October 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lahey Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess effect of local anesthetic into the preperitoneal space during laparoscopic hernia repair on post-operative pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain (Post Laparoscopic Hernia Repair)
Keywords
Post Operative Pain, hernia repair
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
anesthetic intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Saline intervention
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
0.5% Bupivicaine
Other Intervention Name(s)
Marcaine, Sensorcaine
Intervention Description
Local anesthetic
Primary Outcome Measure Information:
Title
Visual Analog Scale Pain Score Assessment (VAS)
Description
Pain level at 4 hours after surgery VAS scale measures pain in whole numbers from 0 (no pain) to 10 (worst imaginable pain)
Time Frame
Post-operative period
Title
Visual Analog Scale Pain Score Assessment (VAS)
Description
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)
Time Frame
Pain scale 3 days after surgery
Secondary Outcome Measure Information:
Title
Amount of Pain Medication Used in Oral Morphine Equivalents
Description
Total mg of opiate after surgery
Time Frame
4 hours after surgery
Title
Duration of Narcotic Used to Control Pain
Description
Number of days post-operatively narcotic is used
Time Frame
4 weeks post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Lahey Hospital & Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
36266481
Citation
Rade M, Jayaram A, Birkett R, Ford H, Birkett D, Nepomnayshy D. A randomized, double-blinded, placebo-controlled trial of the effects of infusing local analgesia on post-operative pain during laparoscopic inguinal hernia repair. Surg Endosc. 2023 Mar;37(3):1970-1975. doi: 10.1007/s00464-022-09697-7. Epub 2022 Oct 20.
Results Reference
derived
Learn more about this trial
Effects of Local Anesthesia on Post-operative Pain During Laparoscopic Inguinal Hernia Repair
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