Effective Maneuver for Post-laparoscopic Shoulder Pain

Kangbuk Samsung Hospital

Status: Completed

Conditions: Gynecologic Diseases

Treatments: Procedure: Normal Saline Instillation + Pulmonary Recruitment; Procedure: Passive Deflation; Procedure: Normal Saline Instillation

Study type: Interventional

Funder types: Other

Identifiers

NCT02811081

2016-05-048

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 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
• pregnant women

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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144 participants in 3 patient groups

Control

Experimental group

Description:

Passive deflation of residual carbon dioxide

Treatment:

Procedure: Passive Deflation

Normal Saline Instillation

Experimental group

Description:

Instillation of isotonic normal saline in the sub-diaphragmatic region

Treatment:

Procedure: Normal Saline Instillation

Combined Intervention

Experimental group

Description:

Normal Saline Instillation + Pulmonary Recruitment

Treatment:

Procedure: Normal Saline Instillation + Pulmonary Recruitment