Pulmonary Recruitment Maneuver With 15 and 30 cmH2O Pressure to Reduce the Postoperative Shoulder Pain

Not Applicable

Completed

• Conditions: Surgery
• Interventions: Other: Pulmonary recruitment maneuver (PRM)- 15 cm H2O; Other: Pulmonary recruitment maneuver (PRM)- 30 cm H2O

• Registration Number: NCT03970473
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

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.

Study Timeline

• Study First Submitted: 2019-05-29
• Study First Submitted QC: 2019-05-30
• Study First Posted: 2019-05-31
• Study Start: 2019-08-02
• Primary Completion: 2019-08-22
• Status Verified: 2019-10
• Study Completion: 2019-10-02
• Last Update Submitted: 2019-10-02
• Last Update Posted: 2019-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 105

Inclusion Criteria

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

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Exclusion Criteria

• Previous lung surgery
• Preexisting Emphysema
• Previous Pneumothorax

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRM 15 cm H2O	Pulmonary recruitment maneuver (PRM)- 15 cm H2O	In this group, following the laparoscopic surgery and just before the extubation, patients will receive PRM with 15 cm H2O in the semi-fowler position.
PRM 30 cm H2O	Pulmonary recruitment maneuver (PRM)- 30 cm H2O	In this group, following the laparoscopic surgery and just before the extubation, patients will receive PRM with 30 cm H2O in the semi-fowler position.

Primary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (1)

Kanuni Sultan Suleyman Training and Research Hospital; 🇹🇷 Istanbul, Please Enter The State Or Province, Turkey