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Completed

NCT Number: NCT02811081

Effective Maneuver for Post-laparoscopic Shoulder Pain

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.

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Key information

Conditions

Gynecologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

19 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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 + 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.

Primary outcomes

  1. Shoulder pain evaluated by 10 point visual analogue scale

    Time frame: after two day of procedure

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

Secondary outcomes

  1. Wound pain evaluated by 10 point visual analogue scale

    Time frame: after two day of procedure

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

Sponsors and collaborators

Lead sponsor

Kangbuk Samsung Hospital

Other

Registry information

Official study title

The Effective Maneuver to Reduce Shoulder Pain After Laparoscopic Gynecologic Surgery: Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 23, 2016
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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