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NCT Number: NCT05530564

Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation in 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 Inflammatory Response Neurologic Manifestations Pain 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. assessment of pain with SPS-11 at 6hr post-op

    Time frame: pre-op to 6 hours 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

  2. change in IL-6

    Time frame: pre op to 24 hours post -op

    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

Secondary outcomes

  1. assessment of difficulty of surgery

    Time frame: start to end of the study, 1 year

    to measure difference in surgery difficulty between the two groups using a scale of 1; easy, 2; moderate, 3; difficult.

    analysis done using Chi-square cross table on SPSS V 1.0.0.1406

  2. assessment of difference in operation time

    Time frame: start to end of the study, 1 year

    to look for difference in operation time between the two groups, calculated in minutes.

    analysis done using Student's 2-tailed t-test on SPSS V 1.0.0.1406

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study title

Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation in Laparoscopic Cholecystectomy: A Prospective Randomized Clinical Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 7, 2022
Registry last updated
Sep 7, 2022

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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