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

Primary Purpose

Pneumoperitoneum, Pain, Inflammation

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
low-pressure pneumoperitoneum
standard-pressure pneumoperitoneum
Sponsored by
University of Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pneumoperitoneum focused on measuring low-pressure pneumoperitoneum, lap chole

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jordan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low-pressure

Standard-pressure

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)
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)
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)
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)
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)
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)
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)
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)
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 )
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)
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)
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)
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)

Secondary Outcome Measures

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
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

Full Information

First Posted
February 27, 2021
Last Updated
March 3, 2021
Sponsor
University of Jordan
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1. Study Identification

Unique Protocol Identification Number
NCT04779515
Brief Title
Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation Post Laparoscopic Cholecystectomy
Official Title
Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation Post Laparoscopic Cholecystectomy: A Randomized, Double-blinded, Controlled, Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
January 22, 2021 (Actual)
Study Completion Date
January 22, 2021 (Actual)

3. Sponsor/Collaborators

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

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumoperitoneum, Pain, Inflammation
Keywords
low-pressure pneumoperitoneum, lap chole

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-pressure
Arm Type
Experimental
Arm Description
Participants undergone laparoscopic cholecystectomy by creation of a low-pressure pneumoperitoneum, set at 8-10 mm Hg
Arm Title
Standard-pressure
Arm Type
Active Comparator
Arm Description
Participants undergone laparoscopic cholecystectomy by creation of a standard-pressure pneumoperitoneum, set at 12-14 mm Hg
Intervention Type
Procedure
Intervention Name(s)
low-pressure pneumoperitoneum
Intervention Description
insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 8 to 10 mm Hg
Intervention Type
Procedure
Intervention Name(s)
standard-pressure pneumoperitoneum
Intervention Description
insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 12 to 14 mm Hg
Primary Outcome Measure Information:
Title
change from baseline in pain on the 11-point short pain scale (SPS-11) at hour 12 post-op
Description
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)
Time Frame
baseline and 12 hours post-op
Title
change from baseline in pain on the 11-point short pain scale (SPS-11) at hour 24 post-op
Description
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)
Time Frame
baseline and 24 hours post-op
Title
change from baseline in pain on the 11-point short pain scale (SPS-11) at day 7 post-op
Description
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)
Time Frame
baseline and 7 days post-op
Title
change from baseline in WBC count at 24hr post op
Description
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)
Time Frame
baseline and 24 hours post-op
Title
change from baseline in Plt count at 24hr post op
Description
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)
Time Frame
baseline and 24 hours post-op
Title
change from baseline in ESR value at 24hr post op
Description
calculate the rise in erythrocyte sedimentation rate value as inflammatory marker post-op in millimeters per hour. change = (post-op ESR) - (baseline ESR)
Time Frame
baseline and 24 hours post-op
Title
change from baseline in CRP level at 24hr post op
Description
calculate the rise in C reactive protein level as inflammatory marker post-op in mg/L change = (post-op CRP) - (baseline CRP)
Time Frame
baseline and 24 hours post-op
Title
change from baseline in Alb level at 24hr post op
Description
calculate the drop in albumin level as inflammatory marker post-op in g/dL change = (baseline Alb) - (post-op baseline Alb)
Time Frame
baseline and 24 hours post-op
Title
change from baseline in cortisol level at 4hr post op
Description
calculate the rise in cortisol level as inflammatory marker post-op in nmol/L change = (post-op cortisol ) - (baseline cortisol )
Time Frame
baseline and 4 hours post-op
Title
change from baseline in IL-6 level at 24hr post op
Description
calculate the rise in interleukin 6 level as inflammatory marker post-op in pg/mL change = (post-op IL-6) - (baseline IL-6)
Time Frame
baseline and 24 hours post-op
Title
change from baseline in IL-17 level at 24hr post op
Description
calculate the rise in interleukin 17 level as inflammatory marker post-op in pg/mL change = (post-op IL-17) - (baseline IL-17)
Time Frame
baseline and 24 hours post-op
Title
change from baseline in IL-1 level at 24hr post op
Description
calculate the rise in interleukin 1 level as inflammatory marker post-op in pg/mL change = (post-op IL-1) - (baseline IL-1)
Time Frame
baseline and 24 hours post-op
Title
change from baseline in TNF level at 24hr post op
Description
calculate the rise in tumor necrosis factor alpha level as inflammatory marker post-op in pg/mL change = (post-op TNF) - (baseline TNF)
Time Frame
baseline and 24 hours post-op
Secondary Outcome Measure Information:
Title
Difference in surgery difficulty level among two groups
Description
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
Time Frame
through study completion, an average of 1 year
Title
Difference in surgery time among two groups
Description
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
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salam Daradkeh, Prof.
Organizational Affiliation
University of Jordan
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mohammad Rashdan, Prof.
Organizational Affiliation
University of Jordan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raed Al-Taher, Prof.
Organizational Affiliation
University of Jordan
Official's Role
Study Director
Facility Information:
Facility Name
Jordan University Hospital
City
Amman
State/Province
Jubaiha
ZIP/Postal Code
13046
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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)

Learn more about this trial

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

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