Local and Intraperitoneal Analgetics in Gynecologic Laparoscopy for Post Operative Pain Relief

NCT ID: NCT02976571

Last Updated: 2018-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-12-31

Brief Summary

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A comparison between local and intraperitoneal analgetics to placebo, during laparoscopy, regarding post operative pain.

Detailed Description

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4 randomly assigned groups. Grop 1 will get sub cutaneous and intraperitoneal marcain. Grop 2 will get sub cutaneous marcaine and intraperitoneal saline. Grop 3 will get sub cutaneus saline and intraperitoneal marcaine. Grop 4 will get ub cutaneous and intraperitoneal saline

Conditions

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Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sub cutaneous+Intraperitoneal

Sub cutaneous Bupivacaine+ Intraperitoneal bupivacaine

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

Sub cutaneous and/or Intraperitoneal Marcaine application

Sub cutaneous+Placebo

Sub cutaneous Bupivacaine+ Intraperitoneal Nacl 0.9%

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

Sub cutaneous and/or Intraperitoneal Marcaine application

Placebo+Intraperitoneal

Sub cutaneous Nacl 0.9%+ Intraperitoneal bupivacaine

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

Sub cutaneous and/or Intraperitoneal Marcaine application

Placebo+Placebo

Sub cutaneous Nacl 0.9%+ Intraperitoneal Nacl 0.9%

Group Type PLACEBO_COMPARATOR

Bupivacaine

Intervention Type DRUG

Sub cutaneous and/or Intraperitoneal Marcaine application

Interventions

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Bupivacaine

Sub cutaneous and/or Intraperitoneal Marcaine application

Intervention Type DRUG

Other Intervention Names

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Marcaine

Eligibility Criteria

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Inclusion Criteria

* Elective laparoscopy

Exclusion Criteria

* Laparotomy Vaginal operations Oncologic operations Chronic use of analgetics due to pelvic pain Pregnancy Operations lasts more than 3 hours
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ohad Gluck, MD

Role: PRINCIPAL_INVESTIGATOR

Wolfson Medical Center

Locations

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Wolfson medical center

Holon, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Ohad Gluck, MD

Role: CONTACT

97235028329

Elad Barer, MD

Role: CONTACT

9725028329

Facility Contacts

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Ohad Gluck, MD

Role: primary

97235028329

References

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Gluck O, Barber E, Feldstein O, Tal O, Kerner R, Keidar R, Wolfson I, Ginath S, Bar J, Sagiv R. The effect of subcutaneous and intraperitoneal anesthesia on post laparoscopic pain: a randomized controlled trial. Sci Rep. 2021 Jan 8;11(1):81. doi: 10.1038/s41598-020-80130-6.

Reference Type DERIVED
PMID: 33420214 (View on PubMed)

Other Identifiers

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0198-16-WOMC

Identifier Type: -

Identifier Source: org_study_id

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