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

Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation Post Laparoscopic Cholecystectomy: A Randomized, Double-blinded, Controlled, Clinical Trial.

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.

Study Overview

• Status: Completed
• Conditions: Pain; Inflammation; Pneumoperitoneum
• Intervention / Treatment: Procedure: low-pressure pneumoperitoneum; Procedure: standard-pressure pneumoperitoneum

Detailed Description

After obtaining informed consent from eligible study participants. patients were randomized into one of two masked groups, labelled red and green. The red-label group was operated at standard-pressure pneumoperitoneum, while the green-label group was operated at low-pressure pneumoperitoneum. Baseline blood samples were obtained pre-operatively for ten inflammatory markers, patients' demographics and intra-operative details collected, then post-operative pain and change in inflammatory markers were followed.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Jubaiha
    • Amman, Jubaiha, Jordan, 13046
      • Jordan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Elective admission for laparoscopic cholecystectomy

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Low-pressure; Participants undergone laparoscopic cholecystectomy by creation of a low-pressure pneumoperitoneum, set at 8-10 mm Hg	Procedure: low-pressure pneumoperitoneum; insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 8 to 10 mm Hg
ACTIVE_COMPARATOR: Standard-pressure; Participants undergone laparoscopic cholecystectomy by creation of a standard-pressure pneumoperitoneum, set at 12-14 mm Hg	Procedure: standard-pressure pneumoperitoneum; insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 12 to 14 mm Hg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline in pain on the 11-point short pain scale (SPS-11) at hour 12 post-op	the SPS-11 is a validated, self-reported numeric instrument assessing pain intensity, ranging from 0 to 10; where 0 is no pain, and 10 is the worst pain felt ever. change = (pain score at 12-hr post-op) - (baseline pain score assessed at 6-hr post-op)	baseline and 12 hours post-op
change from baseline in pain on the 11-point short pain scale (SPS-11) at hour 24 post-op	the SPS-11 is a validated, self-reported numeric instrument assessing pain intensity, ranging from 0 to 10; where 0 is no pain, and 10 is the worst pain felt ever. change = (pain score at 24-hr post-op) - (baseline pain score assessed at 6-hr post-op)	baseline and 24 hours post-op
change from baseline in pain on the 11-point short pain scale (SPS-11) at day 7 post-op	the SPS-11 is a validated, self-reported numeric instrument assessing pain intensity, ranging from 0 to 10; where 0 is no pain, and 10 is the worst pain felt ever. change = (pain score at post-op day 7) - (baseline pain score assessed at 6-hr post-op)	baseline and 7 days post-op
change from baseline in WBC count at 24hr post op	calculate the rise in white blood cycles count as inflammatory marker post-op in 1000 cells per cubic millimeter of blood. change = (post-op WBC count) - (baseline WBC count)	baseline and 24 hours post-op
change from baseline in Plt count at 24hr post op	calculate the rise in platelets count as inflammatory marker post-op in × 10^9/L of blood change = (post-op Plt count) - (baseline Plt count)	baseline and 24 hours post-op
change from baseline in ESR value at 24hr post op	calculate the rise in erythrocyte sedimentation rate value as inflammatory marker post-op in millimeters per hour. change = (post-op ESR) - (baseline ESR)	baseline and 24 hours post-op
change from baseline in CRP level at 24hr post op	calculate the rise in C reactive protein level as inflammatory marker post-op in mg/L change = (post-op CRP) - (baseline CRP)	baseline and 24 hours post-op
change from baseline in Alb level at 24hr post op	calculate the drop in albumin level as inflammatory marker post-op in g/dL change = (baseline Alb) - (post-op baseline Alb)	baseline and 24 hours post-op
change from baseline in cortisol level at 4hr post op	calculate the rise in cortisol level as inflammatory marker post-op in nmol/L change = (post-op cortisol ) - (baseline cortisol )	baseline and 4 hours post-op
change from baseline in IL-6 level at 24hr post op	calculate the rise in interleukin 6 level as inflammatory marker post-op in pg/mL change = (post-op IL-6) - (baseline IL-6)	baseline and 24 hours post-op
change from baseline in IL-17 level at 24hr post op	calculate the rise in interleukin 17 level as inflammatory marker post-op in pg/mL change = (post-op IL-17) - (baseline IL-17)	baseline and 24 hours post-op
change from baseline in IL-1 level at 24hr post op	calculate the rise in interleukin 1 level as inflammatory marker post-op in pg/mL change = (post-op IL-1) - (baseline IL-1)	baseline and 24 hours post-op
change from baseline in TNF level at 24hr post op	calculate the rise in tumor necrosis factor alpha level as inflammatory marker post-op in pg/mL change = (post-op TNF) - (baseline TNF)	baseline and 24 hours post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in surgery difficulty level among two groups	assessing level of surgery difficulty between low and standard pressure pneumoperitoneum groups. Difficulty was self reported by operating surgeon as easy (score=1), moderate (score=2), or difficult (score=3). Difference assessed by calculating average between groups	through study completion, an average of 1 year
Difference in surgery time among two groups	assessing difference in insufflation time calculated in minutes between low and standard pressure pneumoperitoneum groups. insufflation time was calculated from time of creation of pneumoperitoneum to deflation of the abdomen. Difference assessed by calculating average between groups	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University of Jordan
• Investigators: Study Chair: Salam Daradkeh, Prof., University of Jordan; Principal Investigator: Mohammad Rashdan, Prof., University of Jordan; Study Director: Raed Al-Taher, Prof., University of Jordan

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 20, 2020
• Primary Completion (ACTUAL): January 22, 2021
• Study Completion (ACTUAL): January 22, 2021

Study Registration Dates

• First Submitted: February 27, 2021
• First Submitted That Met QC Criteria: February 27, 2021
• First Posted (ACTUAL): March 3, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 8, 2021
• Last Update Submitted That Met QC Criteria: March 3, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: low-pressure pneumoperitoneum, lap chole
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Peritoneal Diseases; Pneumoperitoneum; Inflammation
• Other Study ID Numbers: 2243

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: we are willing to share all study data for interested researchers to conduct secondary studies of their own.
• IPD Sharing Time Frame: the data will be available from April,2021 up to the end of 2021 year
• IPD Sharing Access Criteria: Data will be shared for medical investigators interested in the topic of pneumoperitoneum, to request please contact (hanan.ju@gmail.com)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No