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Clinical Trials/NCT02811081
NCT02811081
Completed
N/A

The Effective Maneuver to Reduce Shoulder Pain After Laparoscopic Gynecologic Surgery: Randomized Controlled Trial

Kangbuk Samsung Hospital1 site in 1 country144 target enrollmentJune 26, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Gynecologic Diseases
Sponsor
Kangbuk Samsung Hospital
Enrollment
144
Locations
1
Primary Endpoint
Shoulder pain evaluated by 10 point visual analogue scale
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The aim of this clinical trial is to estimate the efficacy and safety of combined intervention with the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver for reducing post-laparoscopic shoulder pain.

Detailed Description

Shoulder pain after laparoscopy is common and its probable mechanism is residual carbon dioxide gas after surgery. Both the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver could effectively reduce post-laparoscopic shoulder pain. However, the efficacy and safety of combined intervention with normal saline instillation and pulmonary recruitment maneuver have not been investigated yet. The aim of this clinical trial is to estimate the effectiveness of combined intervention with the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver for reducing post-laparoscopic shoulder pain.

Registry
clinicaltrials.gov
Start Date
June 26, 2016
End Date
July 30, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Kangbuk Samsung Hospital
Responsible Party
Principal Investigator
Principal Investigator

Kyoungho Ryu

Clinical assistant 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
  • pregnant women

Outcomes

Primary Outcomes

Shoulder pain evaluated by 10 point visual analogue scale

Time Frame: after two day of procedure

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

Secondary Outcomes

  • Wound pain evaluated by 10 point visual analogue scale(after two day of procedure)

Study Sites (1)

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