NCT02976571

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

2.1 years

First QC Date

November 23, 2016

Last Update Submit

May 8, 2018

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (1)

  • Pain level during movement, 8 hours after laparoscopy

    8 hours

Study Arms (4)

Sub cutaneous+Intraperitoneal

EXPERIMENTAL

Sub cutaneous Bupivacaine+ Intraperitoneal bupivacaine

Drug: Bupivacaine

Sub cutaneous+Placebo

ACTIVE COMPARATOR

Sub cutaneous Bupivacaine+ Intraperitoneal Nacl 0.9%

Drug: Bupivacaine

Placebo+Intraperitoneal

ACTIVE COMPARATOR

Sub cutaneous Nacl 0.9%+ Intraperitoneal bupivacaine

Drug: Bupivacaine

Placebo+Placebo

PLACEBO COMPARATOR

Sub cutaneous Nacl 0.9%+ Intraperitoneal Nacl 0.9%

Drug: Bupivacaine

Interventions

BupivacaineDRUG

Sub cutaneous and/or Intraperitoneal Marcaine application

Also known as: Marcaine
Placebo+IntraperitonealPlacebo+PlaceboSub cutaneous+IntraperitonealSub cutaneous+Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective laparoscopy

You may not qualify if:

  • Laparotomy Vaginal operations Oncologic operations Chronic use of analgetics due to pelvic pain Pregnancy Operations lasts more than 3 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wolfson medical center

Holon, Israel

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33420214DERIVED

MeSH Terms

Conditions

Postoperative Complications

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Ohad Gluck, MD

    Wolfson Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ohad Gluck, MD

CONTACT

97235028329ohadgluck@gmail.com

Elad Barer, MD

CONTACT

9725028329elad.barber@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2016

First Posted

November 29, 2016

Study Start

November 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

May 9, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)