Effective Maneuver for Post-laparoscopic Shoulder Pain

Kangbuk Samsung Hospital144 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

144

Conditions

Gynecologic Diseases

Interventions

Passive DeflationPROCEDURE

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 InstillationPROCEDURE

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 RecruitmentPROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 19 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Kangbuk Samsung Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Shoulder pain evaluated by 10 point visual analogue scale

The pain score was evaluated by 10 point visual analogue scale.

Time frame: after two day of procedure

Secondary Outcomes

Wound pain evaluated by 10 point visual analogue scale

The pain score was evaluated by 10 point visual analogue scale.

Time frame: after two day of procedure

Data from ClinicalTrials.gov

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