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CompletedNCT03970473Updated Oct 3, 2019

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

An interventional study of Pulmonary recruitment maneuver (PRM)- 30 cm H2O and Pulmonary recruitment maneuver (PRM)- 15 cm H2O in Surgery, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-10-03.

Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Surgery

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Keywords

  • gynecologic laparoscopic surgery
  • post-laparoscopic shoulder pain
  • pulmonary recruitment manoeuvre
03

In context

Shoulder Pain

707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.

This study's enrollment of 105 is above the median of 60 across 561 interventional studies indexed under Shoulder Pain.

Browse Shoulder Pain studies →

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital is the lead sponsor of 216 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Previous lung surgery
  • Preexisting Emphysema
  • Previous Pneumothorax
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
105 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherPulmonary 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.

  • OtherPulmonary 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.

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What researchers measure

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

    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.

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Study locations

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

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03970473
Lead sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Responsible party
Gulseren Yilmaz (Principal Investigator, M.D., Kanuni Sultan Suleyman Training and Research Hospital) — Principal investigator
First posted
May 31, 2019
Start date
Aug 2, 2019
Primary completion
Aug 22, 2019
Completion
Oct 2, 2019
Last update
Oct 3, 2019

Study contacts

Gulseren Yilmaz, MD
principal investigator · Kanuni Sultan Suleyman Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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