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Completed

NCT Number: NCT04779515

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

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.

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Key information

Conditions

Pneumoperitoneum Digestive System Diseases Inflammation Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Diseases Signs and Symptoms

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan University Hospital

Amman, Jubaiha, 13046, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

low-pressure pneumoperitoneum

Procedure

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

standard-pressure pneumoperitoneum

Procedure

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

Primary outcomes

  1. change from baseline in pain on the 11-point short pain scale (SPS-11) at hour 12 post-op

    Time frame: baseline and 12 hours 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)

  2. change from baseline in pain on the 11-point short pain scale (SPS-11) at hour 24 post-op

    Time frame: baseline and 24 hours 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)

  3. change from baseline in pain on the 11-point short pain scale (SPS-11) at day 7 post-op

    Time frame: baseline and 7 days 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)

  4. change from baseline in WBC count at 24hr post op

    Time frame: baseline and 24 hours 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)

  5. change from baseline in Plt count at 24hr post op

    Time frame: baseline and 24 hours 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)

  6. change from baseline in ESR value at 24hr post op

    Time frame: baseline and 24 hours 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)

  7. change from baseline in CRP level at 24hr post op

    Time frame: baseline and 24 hours post-op

    calculate the rise in C reactive protein level as inflammatory marker post-op in mg/L change = (post-op CRP) - (baseline CRP)

  8. change from baseline in Alb level at 24hr post op

    Time frame: baseline and 24 hours post-op

    calculate the drop in albumin level as inflammatory marker post-op in g/dL change = (baseline Alb) - (post-op baseline Alb)

  9. change from baseline in cortisol level at 4hr post op

    Time frame: baseline and 4 hours post-op

    calculate the rise in cortisol level as inflammatory marker post-op in nmol/L change = (post-op cortisol ) - (baseline cortisol )

  10. change from baseline in IL-6 level at 24hr post op

    Time frame: baseline and 24 hours 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)

  11. change from baseline in IL-17 level at 24hr post op

    Time frame: baseline and 24 hours 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)

  12. change from baseline in IL-1 level at 24hr post op

    Time frame: baseline and 24 hours 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)

  13. change from baseline in TNF level at 24hr post op

    Time frame: baseline and 24 hours 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 outcomes

  1. Difference in surgery difficulty level among two groups

    Time frame: through study completion, an average of 1 year

    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

  2. Difference in surgery time among two groups

    Time frame: through study completion, an average of 1 year

    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

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 3, 2021
Registry last updated
Mar 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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