Effective Maneuver for Post-laparoscopic Shoulder Pain

NCT02811081 | Completed

• 1 other identifier: 2016-05-048
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gynecologic Diseases

Outcome Measures

Primary Outcomes (1)

• Shoulder pain evaluated by 10 point visual analogue scale

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

  after two day of procedure

Secondary Outcomes (1)

• Wound pain evaluated by 10 point visual analogue scale

  after two day of procedure

Study Arms (3)

Control

EXPERIMENTAL

Passive deflation of residual carbon dioxide

Procedure: Passive Deflation

Normal Saline Instillation

EXPERIMENTAL

Instillation of isotonic normal saline in the sub-diaphragmatic region

Procedure: Normal Saline Instillation

Combined Intervention

EXPERIMENTAL

Normal Saline Instillation + Pulmonary Recruitment

Procedure: Normal Saline Instillation + Pulmonary Recruitment

Interventions

Passive Deflation PROCEDURE

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.

Control

Normal Saline Instillation PROCEDURE

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

Normal Saline Instillation + Pulmonary Recruitment PROCEDURE

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.

Combined Intervention

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kangbuk Samsung Hospital: lead

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

MeSH Terms

Conditions

Genital Diseases, Female

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Taejong Song, MD PhD

  Kangbuk Samsung Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical assistant professor

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: June 23, 2016
• Study Start: June 26, 2016
• Primary Completion: April 19, 2017
• Study Completion: July 30, 2017
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

KR (1)