NCT05214157

Brief Summary

evaluating the two final steps we added to optimize post laparoscopic cholecystectomy pain management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
804

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 20, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2022

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
Last Updated

January 28, 2022

Status Verified

January 1, 2022

Enrollment Period

1.8 years

First QC Date

January 25, 2022

Last Update Submit

January 27, 2022

Conditions

Acute Post-operative PainCholecystectomy, LaparoscopicPain Assessment Pain IntensityPain Intensity

Outcome Measures

Primary Outcomes (1)

  • postoperative pain intensity

    severity by visual analogue scale

    6 - 24 hours

Secondary Outcomes (1)

  • hospital stay

    1-5 days

Study Arms (2)

group A

EXPERIMENTAL

interventional group, final two operative steps applied

Procedure: active gas aspiration

group B

NO INTERVENTION

control group

Interventions

active gas aspirationPROCEDURE

sucking remaining Co2 from the peritoneal cavity and local anaesthetic application at port sites

Also known as: application of Bupivacaine soaked sponge
group A

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who were having symptoms consistent with biliary colic,
  • had ultrasound evidence of gall stones,
  • classified as American Society of Anesthesiology (ASA) I and II
  • ages ranging from 18 to 65 years

You may not qualify if:

  • Patients who refused to give consent,
  • pregnant,
  • had a history of drug abuse,
  • had CBD stones,
  • acute cholecystitis,
  • acute pancreatitis,
  • previous abdominal surgery,
  • history of peritonitis,
  • had carcinoma of the gall bladder Patients who were converted to open surgery,
  • patients who required placement of drains
  • patients with intraoperative complications (CBD injury or liver bed bleeding).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig University

Zagazig, Egypt

Location

MeSH Terms

Conditions

Pain, PostoperativePain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • mohamed l ali, md

    Zagazig University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 25, 2022

First Posted

January 28, 2022

Study Start

March 20, 2020

Primary Completion

December 31, 2021

Study Completion

January 8, 2022

Last Updated

January 28, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)