Pulmonary Recruitment Maneuver for Postlaparoscopic Shoulder Pain

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02596425

Enrollment

Registered

2015-11-04

Start date

2015-11-30

Completion date

2016-05-31

Last updated

2016-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecologic Diseases

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.

Interventions

PROCEDURE40 cmH2O

The intervention was five manual inflations of the lungs with positive pressure ventilation of 40 cmH2O at the end of surgery.

PROCEDURE60 cmH2O

The intervention was five manual inflations of the lungs with positive pressure ventilation of 60 cmH2O at the end of surgery.

PROCEDUREPassive deflation

In the controls, CO2 was removed by the traditional passive deflation of abdominal cavity.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

19 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Shoulder pain	after two day of procedure	The pain score was evaluated by 10 point visual analogue scale.

Secondary

Measure	Time frame	Description
Wound pain	after two day of procedure	The pain score was evaluated by 10 point visual analogue scale.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026