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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05530564
• Other study ID #: 10/2019/1115
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: January 30, 2021

Study information

• Verified date: September 2022
• 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 30, 2021
• Est. primary completion date: January 30, 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
• Inflammatory Response
• 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, 

References & Publications (33)

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Dr. Vidyanand Tripathi, Dr. Angela B Marak, Dr. Resen Rajan S Methikkalam, Dr. Y Priyabarta Singh, Dr. S Tombisana, Prof. S Ranita Devi PGSM. A Comparative Study Between The Low Pressure Versus Standard Pressure Pneumoperitoneum In Laparoscopic Cholecyst... J Dent Med Sci. 2020;19(7):01-10. doi:10.9790/0853-1907140110

Gohil A. Comparison of low pressure versus standard pressure pneumoperitoneum for elective laparoscopic cholecystectomy in a tertiary care institute of western India. Int Surg J. 2018;5(5):1776. doi:10.18203/2349-2902.isj20181569

Hua J, Gong J, Yao L, Zhou B, Song Z. Low-pressure versus standard-pressure pneumoperitoneum for laparoscopic cholecystectomy: a systematic review and meta-analysis. Am J Surg. 2014 Jul;208(1):143-50. doi: 10.1016/j.amjsurg.2013.09.027. Epub 2014 Jan 16. Review. — View Citation

Hypólito OH, Azevedo JL, de Lima Alvarenga Caldeira FM, de Azevedo OC, Miyahira SA, Miguel GP, Becker OM Jr, Machado AC, Nunes Filho GP, Azevedo GC. Creation of pneumoperitoneum: noninvasive monitoring of clinical effects of elevated intraperitoneal pressure for the insertion of the first trocar. Surg Endosc. 2010 Jul;24(7):1663-9. doi: 10.1007/s00464-009-0827-2. Epub 2009 Dec 25. — View Citation

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Mandal A, Ghosh A, Bakshi S. Low pressure versus standard pressure pneumoperitoneum in laparoscopic cholecystectomy: a comparative study. Int Surg J. 2020;7(5):1551. doi:10.18203/2349-2902.isj20201868

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment of pain with SPS-11 at 6hr 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	pre-op to 6 hours post op
Primary	change in IL-6	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	pre op to 24 hours post -op
Secondary	assessment of difficulty of surgery	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	start to end of the study, 1 year
Secondary	assessment of difference in operation time	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	start to end of the study, 1 year