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Clinical Trials/NCT03970473
NCT03970473
Completed
Not Applicable

Pulmonary Recruitment Maneuver With 15 or 30 cmH2O Pressure in Semi-Fowler Position: Which Provides Less Postoperative Shoulder Pain Following Gynecologic Laparoscopic Surgery

Kanuni Sultan Suleyman Training and Research Hospital1 site in 1 country105 target enrollmentAugust 2, 2019
ConditionsSurgery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgery
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Enrollment
105
Locations
1
Primary Endpoint
Postoperative shoulder pain using a Visual Analogue Scale (VAS) based on a 0-10 scale, with 0 meaning no pain and 10 the most intense pain ever experienced
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Pulmonary recruitment maneuver (PRM) has been shown to reduce postoperative shoulder pain by removing excessive intraabdominal gas following laparoscopic surgery(LS). A recent study demonstrated that compared to PRM in the supine position, PRM at semi-fowler position provides better evacuation of the remaining intraabdominal gas following gynecologic LS.

This study aimed to compare the impact of PRM with 15 cm H2O and PRM with 30 cm H2O on postoperative shoulder pain in patients undergoing gynecologic LS.

Detailed Description

Pulmonary recruitment maneuver (PRM) consists of five manual pulmonary inflations where each positive pressure inflation was done for 5 s at a maximum pressure of 30-40 cm H2O in the neutral position. When used after laparoscopic surgery and just before the extubation, PRM has been shown to facilitate the removal of intraabdominal gas and thus reduce the postoperative shoulder pain which is associated with the volume of the gas accumulating under the diaphragm. A recent study demonstrated that compared to PRM in the supine position, PRM at semi-fowler position provides better evacuation of the remaining intraabdominal gas and less postoperative shoulder pain following gynecologic LS. However, whether a PRM with lower pressure is also effective in reducing postoperative intraabdominal gas and postoperative shoulder pain is of question. This study aimed to compare the impact of PRM with two pressures (15 cm H2O or 30 cm H2O) in addition to the semi-fowler position on postoperative shoulder pain in patients undergoing gynecologic LS.

Registry
clinicaltrials.gov
Start Date
August 2, 2019
End Date
October 2, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gulseren Yilmaz

Principal Investigator, M.D.

Kanuni Sultan Suleyman Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • Must be scheduled for LS for benign causes
  • Must be American Society of Anesthesiologists (ASA) class I or II.

Exclusion Criteria

  • Previous lung surgery
  • Preexisting Emphysema
  • Previous Pneumothorax

Outcomes

Primary Outcomes

Postoperative shoulder pain using a Visual Analogue Scale (VAS) based on a 0-10 scale, with 0 meaning no pain and 10 the most intense pain ever experienced

Time Frame: At postoperative 6, 12 and 24 hours using a visual analogue scale (VAS) based on a 0-10 scale, with 0 meaning no pain and 10 the most intense pain ever experienced.

Change in postoperative shoulder pain between the two PRM pressure groups

Study Sites (1)

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