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

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

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.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Other: Pulmonary recruitment maneuver (PRM)- 30 cm H2O; Other: Pulmonary recruitment maneuver (PRM)- 15 cm H2O

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 Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Please Enter The State Or Province
    • Istanbul, Please Enter The State Or Province, Turkey, 34005
      • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Other: Pulmonary recruitment maneuver (PRM)- 30 cm H2O; Pulmonary recruitment maneuver (PRM) consists of five manual pulmonary inflations where each positive pressure inflation will be performed for 5 s at a maximum pressure of 30 cm H2O in the semi-fowler position (30° head-of-bed elevation ). PRM is performed after LS when the main umbilical port is remaining and aims to remove the remaining gas following LS.
ACTIVE_COMPARATOR: 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.	Other: Pulmonary recruitment maneuver (PRM)- 15 cm H2O; Pulmonary recruitment maneuver (PRM) consists of five manual pulmonary inflations where each positive pressure inflation will be performed for 5 s at a maximum pressure of 15 cm H2O in the semi-fowler position (30° head-of-bed elevation ). PRM is performed after LS when the main umbilical port is remaining and aims to remove the remaining gas following LS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change in postoperative shoulder pain between the two PRM pressure groups	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.

Collaborators and Investigators

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 2, 2019
• Primary Completion (ACTUAL): August 22, 2019
• Study Completion (ACTUAL): October 2, 2019

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: May 30, 2019
• First Posted (ACTUAL): May 31, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 3, 2019
• Last Update Submitted That Met QC Criteria: October 2, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: gynecologic laparoscopic surgery; post-laparoscopic shoulder pain; pulmonary recruitment manoeuvre
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: Gulseren3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No