A Randomized, Double-blinded, Placebo-controlled Trial of the Effects of Infusing Local Anesthesia on Post-operative Pain During Laparoscopic Inguinal Hernia Repair
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Lahey Clinic
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale Pain Score Assessment (VAS)
Overview
Brief Summary
To assess effect of local anesthetic into the preperitoneal space during laparoscopic hernia repair on post-operative pain.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
anesthetic intervention
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.
Intervention: 0.5% Bupivicaine (Drug)
Saline intervention
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: 0.5% Bupivicaine (Drug)
Outcomes
Primary Outcomes
Visual Analog Scale Pain Score Assessment (VAS)
Time Frame: 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 Outcomes
- Amount of Pain Medication Used in Oral Morphine Equivalents(4 hours after surgery)
- Duration of Narcotic Used to Control Pain(4 weeks post-op)
Investigators
Dmitry Nepomnayshy
Study Coordinator sub- Investigator
Lahey Clinic