Pulmonary Recruitment Maneuver for Postlaparoscopic Shoulder Pain

Gynecologic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02596425
• Other study ID #: 2015-08-007
• Status: Completed
• Phase: Phase 3
• First received: November 2, 2015
• Last updated: November 29, 2016
• Start date: November 2015
• Est. completion date: May 2016

Study information

• Verified date: November 2016
• Source: Kangbuk Samsung Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review BoardKorea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• 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

• intrauterine pregnant women

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecologic Diseases
• Shoulder Pain

Intervention

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

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	The pain score was evaluated by 10 point visual analogue scale.	after two day of procedure	No
Secondary	Wound pain	The pain score was evaluated by 10 point visual analogue scale.	after two day of procedure	No