Effective Maneuver for Post-laparoscopic Shoulder Pain

Not Applicable

Completed

• Conditions: Gynecologic Diseases
• Interventions: Procedure: Normal Saline Instillation + Pulmonary Recruitment; Procedure: Passive Deflation; Procedure: Normal Saline Instillation

• Registration Number: NCT02811081
• Lead Sponsor: Kangbuk Samsung Hospital

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.

Study Timeline

• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-06-22
• Study First Posted: 2016-06-23
• Study Start: 2016-06-26
• Primary Completion: 2017-04-19
• Study Completion: 2017-07-30
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-07
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined Intervention	Normal Saline Instillation + Pulmonary Recruitment	Normal Saline Instillation + Pulmonary Recruitment
Control	Passive Deflation	Passive deflation of residual carbon dioxide
Normal Saline Instillation	Normal Saline Instillation	Instillation of isotonic normal saline in the sub-diaphragmatic region

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Wound pain evaluated by 10 point visual analogue scale	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