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Optimizing Pain Management Following Laparoscopic Cholecystectomy RCT (Pain)

Primary Purpose

Acute Post-operative Pain, Cholecystectomy, Laparoscopic, Pain Assessment Pain Intensity

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
active gas aspiration
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Post-operative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

Sites / Locations

  • Zagazig University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

group A

group B

Arm Description

interventional group, final two operative steps applied

control group

Outcomes

Primary Outcome Measures

postoperative pain intensity
severity by visual analogue scale

Secondary Outcome Measures

hospital stay
numbers of days

Full Information

First Posted
January 25, 2022
Last Updated
January 27, 2022
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT05214157
Brief Title
Optimizing Pain Management Following Laparoscopic Cholecystectomy RCT
Acronym
Pain
Official Title
A Prospective Randomized Controlled Study on the Role of Restoring Liver-Diaphragm Surface Tension and Pain Control at Port Sites in Optimizing Pain Management Following Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 20, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
January 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
evaluating the two final steps we added to optimize post laparoscopic cholecystectomy pain management.
Detailed Description
Introduction: After a laparoscopic cholecystectomy (LC), pain is still a significant concern, leading to extended hospital stays or readmissions. In majority of patients, postoperative pain medications are required. A standardized strategy is needed to offer effective pain relief postoperatively. The majority of pain in the early postoperative period is due to elimination of intraperitoneal surface tension or of parietal type. Aim of the work: to evaluate the two final steps we added to optimize postoperative pain management. Patients and methods: Over the period from March 2020 to December 2021, 816 patients with gallbladder stone undergoing LC were randomized into 2 groups after exclusion of 12 patients: Group A; interventional contained 402 patients. Group B; control contained 402 patients. Post-operative data to be compared were made in terms of operative time, shoulder pain, upper abdominal pain, (at 6,12,18 and 24 hours) and number of analgesic doses and hospital stay. Pain intensity was assessed by using the visual analogue scale (VAS) for each patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Post-operative Pain, Cholecystectomy, Laparoscopic, Pain Assessment Pain Intensity, Pain Intensity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
804 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Experimental
Arm Description
interventional group, final two operative steps applied
Arm Title
group B
Arm Type
No Intervention
Arm Description
control group
Intervention Type
Procedure
Intervention Name(s)
active gas aspiration
Other Intervention Name(s)
application of Bupivacaine soaked sponge
Intervention Description
sucking remaining Co2 from the peritoneal cavity and local anaesthetic application at port sites
Primary Outcome Measure Information:
Title
postoperative pain intensity
Description
severity by visual analogue scale
Time Frame
6 - 24 hours
Secondary Outcome Measure Information:
Title
hospital stay
Description
numbers of days
Time Frame
1-5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohamed l ali, md
Organizational Affiliation
Zagazig University
Official's Role
Study Director
Facility Information:
Facility Name
Zagazig University
City
Zagazig
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Optimizing Pain Management Following Laparoscopic Cholecystectomy RCT

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