Effects of Local Anesthesia on Post-operative Pain During Laparoscopic Inguinal Hernia Repair
NCT ID: NCT02055053
Last Updated: 2022-01-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
70 participants
INTERVENTIONAL
2013-08-31
2019-10-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
0.5% Bupivicaine
Local anesthetic
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.
0.5% Bupivicaine
Local anesthetic
Interventions
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0.5% Bupivicaine
Local anesthetic
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiology (ASA) Class I and II
Exclusion Criteria
* History of Chronic pain or ongoing treatment for chronic pain
* Age less than 18 yrs
* Allergy to local anesthetics
18 Years
ALL
Yes
Sponsors
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Lahey Clinic
OTHER
Responsible Party
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Dmitry Nepomnayshy
Study Coordinator sub- Investigator
Locations
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Lahey Hospital & Medical Center
Burlington, Massachusetts, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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LCID 2013-031
Identifier Type: -
Identifier Source: org_study_id
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