Pulmonary Recruitment Maneuver for Postlaparoscopic Shoulder Pain

Kangbuk Samsung Hospital

Status and phase: Completed; Phase 3

Conditions: Gynecologic Diseases

Treatments: Procedure: Passive deflation; Procedure: 60 cmH2O; Procedure: 40 cmH2O

Study type: Interventional

Funder types: Other

Identifiers

NCT02596425

2015-08-007

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: Female

Ages: 19 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

Passive deflation

Experimental group

Description:

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

Treatment:

Procedure: Passive deflation

40 cmH2O

Experimental group

Description:

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

Treatment:

Procedure: 40 cmH2O

60 cmH2O

Experimental group

Description:

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

Treatment:

Procedure: 60 cmH2O