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Completed

NCT Number: NCT04642118

Low-pressure Pulmonary Recruitment Maneuver to Decrease Post-laparoscopic Shoulder Pain in Gynecologic Surgery

Research objective to compare outcomes (shoulder pain score, wound pain score, post-operative residual pneumoperitoneum, lung complication, GI discomfort, administered additional analgesics, time to hospital staying) of using Pulmonary Recruitment maneuver with pressure 30 cmH2O, 40 cm H2O and control group in women with post laparoscopic gynecologic surgery in Rajavithi hospital.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rajavithi hospital

Bangkok, 10400, Thailand

About this study

Research design is Randomized control trial. The women who go to laparoscopic gynecologic surgery don't know the allocation. Women will be randomizes in to 3 group: PRM 30 cmH2O, 40 cmH2O and control

After laparoscopic surgery has finished in operator room (before moving off trocar), woman all group will be set in Trenderlenberg position (Tilted head low) and then surgeon will compress abdomen to release residual gas after operation about 2 minutes.

The patients in group of using Pulmonary Recruitment Maneuver will be received positive pressure from balloon bag from anesthesiologist 5 times of setting pressure [30 cmH2O, 40 cmH2O], 5 seconds per time to increase indirect abdominal pressure to release residual gas

After surgery at 12, 24 and 48 hours, patients will be follow up and evaluate shoulder and wound pain. Chest X-ray will be done to evaluate residual pneumoperitoneum and lung complication. GI discomfort, administered additional analgesics and time to hospital staying will be evaluated and recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 65 years
  • Anesthesiologists physical status (ASAPS) classification I-II
  • Absence of Pregnancy
  • With inform-consent

Exclusion criteria

  • Inability to accurately express pain
  • Past history of shoulder or lung surgery
  • Chronic shoulder problem
  • Epigastric pain
  • Lung disease such as emphysema or pneumothorax
  • Severe kidney or liver disease
  • Drug allergy (NSAIDs, Paracetamol)
  • On current medication: corticosteroid
  • Psychiatric disorder

Treatment and study plan

Pulmonary recruitment maneuver

Procedure

Using setting pressure form ventilator to increase pulmonary pressure by compress balloon bag 5 times, 5 seconds per time

Primary outcomes

  1. shoulder pain from using PRM 30 cmH2O

    Time frame: During stay in hospital around 2-3 days

    To compare shoulder pain score(Visual analogue scale from score 0(no pain) to score 10 (maximum pain)) after laparoscopic gynecologic surgery between PRM at 30 cmH2O group and control group at 12, 24 and 48 hrs.

Secondary outcomes

  1. wound pain

    Time frame: During stay in hospital around 2-3 days

    evaluate with Visual analogue scale from score 0(no pain) to score 10 (maximum pain)

  2. shoulder pain from using PRM 40 cmH2O

    Time frame: During stay in hospital around 2-3 days

    To compare shoulder pain score(Visual analogue scale from score 0(no pain) to score 10 (maximum pain)) after laparoscopic gynecologic surgery between PRM at 40 cmH2O group and control group at 12, 24 and 48 hrs.

  3. Post-operative residue pneumoperitoneum

    Time frame: after surgery in day 1

    Residue air volume in abdominal cavity will be measured (Hight from diaphragm to upper border of liver (cm.)) from Chest x-ray PA upright

  4. Lung complication

    Time frame: after surgery in day 1

    Number of participants with complication (incident) such as pneumothorax, Lung atelectasis, Pleural effusion etc. will be recorded

  5. GI discomfort

    Time frame: during stay in hospital around 2-3 days

    number of symptom

  6. Time to hospital staying

    Time frame: During stay in hospital around 2-3 days

    record day which stay in hospital with abnormal condition

  7. Administered additional analgesics

    Time frame: During stay in hospital around 2-3 days

    number of morphine using

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Official study title

Low-pressure Pulmonary Recruitment Maneuver to Decrease Post-laparoscopic Shoulder Pain in Gynecologic Surgery: A Double-blind Randomized Placebo Controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 24, 2020
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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