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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02055053
Recruitment Status : Completed
First Posted : February 4, 2014
Results First Posted : December 14, 2020
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Dmitry Nepomnayshy, Lahey Clinic

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

Condition or disease Intervention/treatment Phase
Post Operative Pain (Post Laparoscopic Hernia Repair) Drug: 0.5% Bupivicaine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : August 2013
Actual Primary Completion Date : October 16, 2019
Actual Study Completion Date : October 16, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: 0.5% Bupivicaine
Local anesthetic
Other Names:
  • Marcaine
  • Sensorcaine
Placebo Comparator: 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.
 Drug: 0.5% Bupivicaine
Local anesthetic
Other Names:
  • Marcaine
  • Sensorcaine


Outcome Measures
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Primary Outcome Measures :
  1. Visual Analog Scale Pain Score Assessment (VAS) [ Time Frame: Post-operative period ]
    Pain level at 4 hours after surgery VAS scale measures pain in whole numbers from 0 (no pain) to 10 (worst imaginable pain)

  2. 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 Outcome Measures :
  1. Amount of Pain Medication Used in Oral Morphine Equivalents [ Time Frame: 4 hours after surgery ]
    Total mg of opiate after surgery

  2. Duration of Narcotic Used to Control Pain [ Time Frame: 4 weeks post-op ]
    Number of days post-operatively narcotic is used


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055053


Locations
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United States, Massachusetts
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
  Study Documents (Full-Text)

Documents provided by Dmitry Nepomnayshy, Lahey Clinic:
Study Protocol and Statistical Analysis Plan  [PDF] June 17, 2013

More Information
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Responsible Party: Dmitry Nepomnayshy, Study Coordinator sub- Investigator, Lahey Clinic
ClinicalTrials.gov Identifier: NCT02055053    
Other Study ID Numbers: LCID 2013-031
First Posted: February 4, 2014    Key Record Dates
Results First Posted: December 14, 2020
Last Update Posted: January 11, 2022
Last Verified: December 2021
Keywords provided by Dmitry Nepomnayshy, Lahey Clinic:
Post Operative Pain
hernia repair
Additional relevant MeSH terms:
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Hernia
Pain, Postoperative
Hernia, Inguinal
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
 Hernia, Abdominal
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents