Outcome of Active Aspiration Versus Simple Compression to Remove Residual Gas From Abdominal Cavity in Reducing Pain After Laparoscopic Cholecystectomy

NCT07299656 | Not Yet Recruiting

• 1 other identifier: Kemu/draizaztariq
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to compare outcome of active aspiration versus simple compression to remove residual gas from abdominal cavity in reducing pain after laparoscopic cholecystectomy.

Conditions

Abdominal Pain (AP); Shoulder Pain

Keywords

abdominal pain; shoulder pain; laparoscopic procedure; cholecystectomy; pneumoperitonium; lap chole; laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Numerical Pain Intensity Scale (NPIS)

  The Numerical Pain Intensity Scale (NPIS) is a simple, self-reported tool commonly used in clinical settings to assess the intensity of a person's pain. It typically ranges from 0 to 10, with 0 indicating "no pain" and 10 representing "the worst pain imaginable." Patients are asked to rate their pain based on their current experience, providing healthcare professionals with a clear indication of the pain's severity. This scale is useful for tracking pain changes over time, evaluating the effectiveness of treatments, and facilitating communication between patients and providers about pain management. The NPIS is valued for its ease of use and ability to provide quick, quantifiable insights into a patient's pain level.

  24 hours

Study Arms (2)

Group B (Simple compression)

PLACEBO COMPARATOR

In this group, diagnostic laparoscopies commenced with a 5 mm intraumbilical vertical incision, followed by placement of the first bladeless umbilical port trocar (using 5 mm XCEL). Warm CO2 gas insufflation will create the pneumoperitoneum at a flow rate of 1-2.5 L/min; intra-abdominal pressure will be set at 12 mmHg. Patients will then placed in the Trendelenburg position (45°) and the second trocars (using 5 mm XCEL) will be placed at the suprapubic area. Chromopertubation with methylene blue will be performed, with electrocauterization of the endometriotic lesions if necessary. CO2 insufflation will be then ceased and all trocars will be opened. The surgeon will apply abdominal pressure to evacuate any residual CO2. The patient will be then placed in a neutral (horizon plane) position, the trocars will be removed and the incision closed.

Behavioral: simple compression

Group A (Active gas aspiration)

ACTIVE COMPARATOR

Active Gas Aspiration: Once the trocars will be opened, aspiration cannula will be then placed through the accessory port reach at the subdiaphragmatic under direct visualization. After cessation of CO2 insufflation, residual gas will be removed by suctioning with 100 mmHg of pressure until the infra-diaphragmatic area of the abdominal wall close to liver surface. Negative pressure will be then ceased and the aspiration cannula will be taken out under direct vision. The procedure will be completed using the same method as the simple compression group.

Procedure: Group A (Active Aspiration)

Interventions

Group A (Active Aspiration) PROCEDURE

Once the trocars will be opened, aspiration cannula will be then placed through the accessory port reach at the subdiaphragmatic under direct visualization. After cessation of CO2 insufflation, residual gas will be removed by suctioning with 100 mmHg of pressure until the infra-diaphragmatic area of the abdominal wall close to liver surface. Negative pressure will be then ceased and the aspiration cannula will be taken out under direct vision. The procedure will be completed using the same method as the simple compression group.

Group A (Active gas aspiration)

simple compression BEHAVIORAL

Active Gas Aspiration: Once the trocars will be opened, aspiration cannula will be then placed through the accessory port reach at the subdiaphragmatic under direct visualization. After cessation of CO2 insufflation, residual gas will be removed by suctioning with 100 mmHg of pressure until the infra-diaphragmatic area of the abdominal wall close to liver surface. Negative pressure will be then ceased and the aspiration cannula will be taken out under direct vision. The procedure will be completed using the same method as the simple compression group.

Group B (Simple compression)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both genders.
• Patients of age ≥ 18 years.
• All patients presenting for elective laparoscopic cholecystectomy.

You may not qualify if:

• Patients suffering from obstructive jaundice anamnesis.
• Patients who had received a diagnosis of gallbladder cancer.
• Patients whose procedures were converted to open cholecystectomy during the surgery.
• Patients who had additional pathologies such as bronchial asthma, chronic obstructive pulmonary disease.
• Patients refused to give consent.

Sponsors & Collaborators

• King Edward Medical University: lead

Related Publications (9)

• Erdem H, Gençtürk M, Çetinkünar S, Şişik A, Sözen S. The effect of active gas aspiration to reduce pain after laparoscopic sleeve gastrectomy for morbid obesity: a randomized controlled study. Archives of Medical Science-Civilization Diseases. 2021;6(1):109-16.

  RESULT

• Leelasuwattanakul N, Bunyavehchevin S, Sriprachittichai P. Active gas aspiration versus simple gas evacuation to reduce shoulder pain after diagnostic laparoscopy: A randomized controlled trial. J Obstet Gynaecol Res. 2016 Feb;42(2):190-4. doi: 10.1111/jog.12868. Epub 2015 Dec 3.

  PMID: 26633582 RESULT

• Rosenberg J, Fuchs-Buder T. Low-pressure pneumoperitoneum-why and how. Laparoscopic Surgery. 2023 Oct 30;7.

  RESULT

• Umano GR, Delehaye G, Noviello C, Papparella A. The "Dark Side" of Pneumoperitoneum and Laparoscopy. Minim Invasive Surg. 2021 May 19;2021:5564745. doi: 10.1155/2021/5564745. eCollection 2021.

  PMID: 34094598 RESULT

• Sao CH, Chan-Tiopianco M, Chung KC, Chen YJ, Horng HC, Lee WL, Wang PH. Pain after laparoscopic surgery: Focus on shoulder-tip pain after gynecological laparoscopic surgery. J Chin Med Assoc. 2019 Nov;82(11):819-826. doi: 10.1097/JCMA.0000000000000190.

  PMID: 31517775 RESULT

• Özgönül A, Yalçın M, Öter V, Tatlı F, Yücel Y. The relationship between early postoperative pain and intraperitoneal residual gas after laparoscopic cholecystectomy. Laparoscopic Endoscopic Surgical Science (LESS).;25(2):59-63.

  RESULT

• Park SJ. Postoperative Shoulder Pain after Laparoscopic Surgery. J Minim Invasive Surg. 2020 Mar 15;23(1):3-4. doi: 10.7602/jmis.2020.23.1.3.

  PMID: 35600729 RESULT

• Khalid A, Khalil K, Mehmood Qadri H, Ahmad CZ, Fatima W, Raza A, Asif MA, Luqman MS, Jawariah, Nizami MFK. Comparison of Postoperative Complications of Open Versus Laparoscopic Cholecystectomy According to the Modified Clavien-Dindo Classification System. Cureus. 2023 Aug 17;15(8):e43642. doi: 10.7759/cureus.43642. eCollection 2023 Aug.

  PMID: 37727181 RESULT

• Mannam R, Sankara Narayanan R, Bansal A, Yanamaladoddi VR, Sarvepalli SS, Vemula SL, Aramadaka S. Laparoscopic Cholecystectomy Versus Open Cholecystectomy in Acute Cholecystitis: A Literature Review. Cureus. 2023 Sep 21;15(9):e45704. doi: 10.7759/cureus.45704. eCollection 2023 Sep.

  PMID: 37868486 RESULT

MeSH Terms

Conditions

Shoulder Pain; Abdominal Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study Design: Comparative study Setting: East Surgical Ward, Mayo Hospital, Lahore. Duration of Study: Six months after approval of synopsis. Sample Size: 62 cases in each group were calculated by taking 5 % level of significance and 80% power of study with expected population proportion of analgesics requirement 43.2% in active gas aspiration group versus 67.6% in simple compression group (p value \< 0.001). \[9\] Sampling Technique: Simple random sampling technique

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 23, 2025
• Study Start: December 11, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12