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

NCT03970473 | Completed

• 1 other identifier: Gulseren3
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Keywords

gynecologic laparoscopic surgery; post-laparoscopic shoulder pain; pulmonary recruitment manoeuvre

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

PRM 30 cm H2O

ACTIVE COMPARATOR

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

PRM 15 cm H2O

ACTIVE COMPARATOR

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

Interventions

Pulmonary recruitment maneuver (PRM)- 30 cm H2O OTHER

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.

PRM 30 cm H2O

Pulmonary recruitment maneuver (PRM)- 15 cm H2O OTHER

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.

PRM 15 cm H2O

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previous lung surgery
• Preexisting Emphysema
• Previous Pneumothorax

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Please Enter the State Or Province, 34005, Turkey (Türkiye)

Location

Study Officials

• Gulseren Yilmaz, MD

  Kanuni Sultan Suleyman Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, M.D.

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: May 31, 2019
• Study Start: August 2, 2019
• Primary Completion: August 22, 2019
• Study Completion: October 2, 2019
• Last Updated: October 3, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)