Effective Maneuver for Post-laparoscopic Shoulder Pain

Gynecologic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02811081
• Other study ID #: 2016-05-048
• Status: Completed
• Phase: N/A
• Start date: June 26, 2016
• Est. completion date: July 30, 2017

Study information

• Verified date: May 2018
• Source: Kangbuk Samsung Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: July 30, 2017
• Est. primary completion date: April 19, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecologic Diseases
• Shoulder Pain

Intervention

Procedure:
• Passive Deflation
In the control group, residual carbon dioxide gas was evacuated by the routine method using passive exsufflation through the port site at the end of surgery.
• Normal Saline Instillation
In the normal saline instillation group, in addition to the routine method, the patients were placed in the Trendelenburg position (30°), isotonic normal saline (20 ml/kg of body weight) was infused in the sub-diaphragmatic region at the end of surgery.
• Normal Saline Instillation + Pulmonary Recruitment
In the combined intervention group, in addition to the routine method, the patients were placed in the Trendelenburg position (30°), and a pulmonary recruitment maneuver was performed after instillation of isotonic normal saline (20 ml/kg of body weight) in the sub-diaphragmatic region at the end of surgery.

Locations

Country	Name	City	State
Korea, Republic of	Kangbuk Samsung Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder pain evaluated by 10 point visual analogue scale	The pain score was evaluated by 10 point visual analogue scale.	after two day of procedure
Secondary	Wound pain evaluated by 10 point visual analogue scale	The pain score was evaluated by 10 point visual analogue scale.	after two day of procedure