Pulmonary Recruitment Maneuver for Postlaparoscopic Shoulder Pain

Phase 3

Completed

• Conditions: Gynecologic Diseases
• Interventions: Procedure: 60 cmH2O; Procedure: 40 cmH2O; Procedure: Passive deflation

• Registration Number: NCT02596425
• Lead Sponsor: Kangbuk Samsung Hospital

Brief Summary

The aim of this clinical trial is to evaluate the efficacy and safety of different recruitment maneuvers for reducing postlaparoscopic shoulder pain.

Detailed Description

Shoulder pain after laparoscopy is common and its probable mechanism is residual CO2 gas after surgery. The pulmonary recruitment maneuver can mechanically remove residual CO2 and reduce pain. In literature, there are two different recruitment maneuvers, which was manual inflation of the lungs with positive pressure ventilation of either 40cmH2O or 60cmH2O at the end of surgery. However, the higher positive pressure may be associated with more chance of barotrauma. Therefore, it is important to determine the lowest effective pressure for reducing postlaparoscopic shoulder pain. The aim of this clinical trial is to evaluate the efficacy and safety of different recruitment maneuvers (40cmH2O or 60cmH2O) for reducing postlaparoscopic shoulder pain.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-02
• Study First Submitted QC: 2015-11-02
• Study First Posted: 2015-11-04
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-29
• Last Update Posted: 2016-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• patients undergoing laparoscopy for benign gynecologic diseases
• patients aged 19-65 years
• patients with american society of anesthesiology physical status I-II
• patients obtaining written informed consent

Exclusion Criteria

• patients with chronic shoulder pain, chronic epigastric pain or chronic pain syndrome
• patients with past history of pneumothorax or any pulmonary surgical history
• patients with any shoulder surgery histories
• patients who required to conversion to open surgery from laparoscopic surgery
• patients who required to receive incidental upper abdominal surgeries due to adhesion and injury at upper abdominal cavity
• patients with inability to understand or express 10 point visual analogue scale
• intrauterine pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
60 cmH2O	60 cmH2O	The intervention was five manual inflations of the lungs with positive pressure ventilation of 60 cmH2O at the end of surgery.
40 cmH2O	40 cmH2O	The intervention was five manual inflations of the lungs with positive pressure ventilation of 40 cmH2O at the end of surgery.
Passive deflation	Passive deflation	In the controls, CO2 was removed by the traditional passive deflation of abdominal cavity.

Primary Outcome Measures

Name	Time	Method
Shoulder pain	after two day of procedure	The pain score was evaluated by 10 point visual analogue scale.

Secondary Outcome Measures

Name	Time	Method
Wound pain	after two day of procedure	The pain score was evaluated by 10 point visual analogue scale.

Trial Locations

Locations (1)

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of