The Influence of Combining the Pulmonary Recruitment Maneuver with Active Gas Aspiration on Post-laparoscopic Shoulder Pain in Patients Having a Gynecologic Laparoscopy, Randomized Double Blinded Clinical Trial

NCT06753292 | Not Yet Recruiting

• 1 other identifier: pulm recruit gas aspir Gyn lap
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

Laparoscopy is among the most used minimally invasive procedures that can reduce postoperative pain, lessen the duration of hospital stay and facilitate recovery. Laparoscopy has been widely used in various abdominal surgeries, such as gastrectomy, cholecystectomy, appendectomy, hernia and gynecological surgery . However, the post-laparoscopic shoulder pain (PLSP) often occurs following laparoscopic surgeries, and its reported incidence varies from 35-80% This study aims to assess the effect of combining pulmonary recruitment maneuvers (PRM) with active gas aspiration on post-laparoscopic shoulder pain in patients undergoing gynecological laparoscopic procedures.

Conditions

Post Laparoscopic Shoulder Pain

Keywords

pulmonary recruitment maneuver; active gas aspiration

Outcome Measures

Primary Outcomes (1)

• post-laparoscopic shoulder pain by VAS score

  post-laparoscopic shoulder pain by VAS score

  24 hours

Study Arms (2)

group 1

EXPERIMENTAL

The surgeon will be instructed to actively aspirate the intraperitoneal CO2 gas

Procedure: active gas aspiration

group 2

EXPERIMENTAL

The surgeon will be instructed to apply PRM pressures. patients will receive the PRM which consisted of five manual pulmonary inflations,

Procedure: pulmonary recruitment maneuver

Interventions

active gas aspiration PROCEDURE

surgeon will be instructed to actively aspirate the intraperitoneal CO2 gas

group 1

pulmonary recruitment maneuver PROCEDURE

patients will receive the PRM which consisted of five manual pulmonary inflations, where each positive pressure inflation will be done for 5 s at a maximum pressure of 30 cm H2O, manually by using the APL valve in the anesthesia machine. The patient will be in a Trendelenburg position (30°). The fifth positive pressure inflation lasted for approximately 5 s. During that time, the patient will be closely monitored, while the anesthesiologist performed PRM

group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18- 65 years.
• American Society of Anesthesiologists physical status classification (ASA) I - II
• scheduled for an elective gyncologic laparoscopic procedures

You may not qualify if:

• Urgent or emergency case.
• ASA classification more than III.
• Age less than 16 years.
• Reduced left and right ventricular function (ejection fraction \<40%).
• Previous respiratory disease such as chronic obstructive pulmonary disease, restrictive lung disease, or had a history of thoracic or shoulder surgery
• Patient conversion to a laparotomy.
• the operation time is more than 3 h

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• Samarah BM, Shehada FA, Qaddumi J, Almasry NA, Alhroub N, ALBashtawy B, Mohammad K, ALBashtawy S, Alkhawaldeh A, ALBashtawy M, Al Omari O, Aljezawi M, Hamadneh S, Suliman M, Hani SB, ALBashtawy Z. The influence of the pulmonary recruitment maneuver on post-laparoscopic shoulder pain in patients having a laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc. 2023 Nov;37(11):8473-8482. doi: 10.1007/s00464-023-10450-x. Epub 2023 Sep 26.

  PMID: 37752263 BACKGROUND

• Ryu KH, Lee SH, Cho EA, Kim JA, Lim GE, Song T. Comparison of impacts of intraperitoneal saline instillation with and without pulmonary recruitment maneuver on post-laparoscopic shoulder pain prevention: a randomized controlled trial. Surg Endosc. 2019 Mar;33(3):870-878. doi: 10.1007/s00464-018-6354-2. Epub 2018 Jul 16.

  PMID: 30014331 BACKGROUND

• Demouron M, Selvy M, Dembinski J, Mauvais F, Cheynel N, Slim K, Sabbagh C, Regimbeau JM. Feasibility and Effectiveness of an Enhanced Recovery Program after Early Cholecystectomy for Acute Calculous Cholecystitis: A 2-Step Study. J Am Coll Surg. 2022 May 1;234(5):840-848. doi: 10.1097/XCS.0000000000000123.

  PMID: 35426396 BACKGROUND

Central Study Contacts

Mahmoud Essam Salama Hammam, resident doctor

CONTACT

+201098209345‬‬‬‬; mahmoudhamam98@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at Assiut University hospital

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: December 31, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 31, 2024

Record last verified: 2024-12