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

NCT ID: NCT02055053

Last Updated: 2022-01-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2019-10-16

Brief Summary

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

Detailed Description

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Conditions

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Post Operative Pain (Post Laparoscopic Hernia Repair)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Group Type EXPERIMENTAL

0.5% Bupivicaine

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

0.5% Bupivicaine

Intervention Type DRUG

Local anesthetic

Interventions

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0.5% Bupivicaine

Local anesthetic

Intervention Type DRUG

Other Intervention Names

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Marcaine Sensorcaine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lahey Clinic

OTHER

Sponsor Role lead

Responsible Party

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Dmitry Nepomnayshy

Study Coordinator sub- Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lahey Hospital & Medical Center

Burlington, Massachusetts, United States

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 36266481 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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LCID 2013-031

Identifier Type: -

Identifier Source: org_study_id

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