Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation in Laparoscopic Cholecystectomy

NCT05530564 | Completed

• 1 other identifier: 10/2019/1115
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effect of low-pressure pneumoperitoneum on post operative pain and inflammation in patients undergoing elective laparoscopic cholecystectomy by comparing it to standard practice.

Conditions

Pneumoperitoneum; Pain; Inflammatory Response

Keywords

Clinical trial; low pressure insufflation; pneumoperitoneum; laparoscopic cholecystectomy; pain; inflammatory marker

Outcome Measures

Primary Outcomes (2)

• assessment of pain with SPS-11 at 6hr post-op

  measure difference in pain on the 11-point short pain scale (SPS-11) at 6-hour post-op compared to baseline at pre-op, minimum score of 0 , maximun score of 10 = pain at 6 hour post op - pain at pre-op

  pre-op to 6 hours post op

• change in IL-6

  measure differance of inflammatory marker from baseline = baseline value- post op value (calculated in pg/mL) post-op collected at 24 hours from end of surgery

  pre op to 24 hours post -op

Secondary Outcomes (2)

• assessment of difficulty of surgery

  start to end of the study, 1 year

• assessment of difference in operation time

  start to end of the study, 1 year

Study Arms (2)

Low-pressure pneumoperitoneum

EXPERIMENTAL

Participants undergone laparoscopic cholecystectomy by creation of a low-pressure pneumoperitoneum, set at 8-10 mm Hg

Procedure: low-pressure pneumoperitoneum

Standard-pressure pneumoperitoneum

ACTIVE COMPARATOR

Participants undergone laparoscopic cholecystectomy by creation of a standard-pressure pneumoperitoneum, set at 12-14 mm Hg

Procedure: standard-pressure pneumoperitoneum

Interventions

low-pressure pneumoperitoneum PROCEDURE

insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 8 to 10 mm Hg

Low-pressure pneumoperitoneum

standard-pressure pneumoperitoneum PROCEDURE

insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 12 to 14 mm Hg

Standard-pressure pneumoperitoneum

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Elective admission for laparoscopic cholecystectomy

You may not qualify if:

• Current or previous diagnosis of acute cholecystitis confirmed by ultrasound
• previous GI surgeries, except bariatric and anti-reflux surgeries
• Currently on immunosuppressant agents
• Pregnancy
• Breastfeeding
• Currently diagnosed with drug addiction
• American Society of Anesthesiologists (ASA) score 3 and more

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

Jordan University Hospital

Amman, Jubaiha, 13046, Jordan

Location

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MeSH Terms

Conditions

Pneumoperitoneum; Pain

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: none of the participants knew at which pressure they will be operated on, nor the physicians who followed participants at floor or those analyzing blood samples, not the assigned physician to collect data, nor the personnel doing the analysis. only the operating surgeon and circulating nurse were aware of the meaning of the participant assigned label at time of operation. The masking was revealed post completion of analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Hanan Mansour, M.D.

Model Details: participants were divided into two masked groups, labelled red and green; those operated at low-pressure pneumoperitoneum (green-label) and those operated at standard-pressure pneumoperitoneum (red-label).

Study Record Dates

• First Submitted: August 27, 2022
• First Posted: September 7, 2022
• Study Start: January 1, 2020
• Primary Completion: January 30, 2021
• Study Completion: January 30, 2021
• Last Updated: September 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

JO (1)