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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04779515
• Other study ID #: 2243
• Status: Completed
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: January 22, 2021

Study information

• Verified date: March 2021
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 22, 2021
• Est. primary completion date: January 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Pain
• Pneumoperitoneum

Intervention

Procedure:
• low-pressure pneumoperitoneum
insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 8 to 10 mm Hg
• standard-pressure pneumoperitoneum
insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 12 to 14 mm Hg

Locations

Country	Name	City	State
Jordan	Jordan University Hospital	Amman	Jubaiha

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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