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Clinical Trials/NCT02596425
NCT02596425
Completed
Phase 3

Pulmonary Recruitment Maneuver to Reduce Postlaparoscopic Shoulder Pain: Randomized Controlled Trial

Kangbuk Samsung Hospital1 site in 1 country90 target enrollmentNovember 2015

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Gynecologic Diseases
Sponsor
Kangbuk Samsung Hospital
Enrollment
90
Locations
1
Primary Endpoint
Shoulder pain
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2015
End Date
May 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Kangbuk Samsung Hospital
Responsible Party
Principal Investigator
Principal Investigator

Taejong Song

Professor

Kangbuk Samsung Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Shoulder pain

Time Frame: after two day of procedure

The pain score was evaluated by 10 point visual analogue scale.

Secondary Outcomes

  • Wound pain(after two day of procedure)

Study Sites (1)

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