Gynecologic DiseaseNCT04642118
Low-pressure Pulmonary Recruitment Maneuver to Decrease Post-laparoscopic Shoulder Pain in Gynecologic Surgery
A study testing Pulmonary recruitment maneuver in people with Gynecologic Disease and Laparoscopic Surgery, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Gynecologic Disease, Laparoscopic Surgery
- What is being tested?
- Pulmonary recruitment maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- 1 Oct 2020to 10 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- Anesthesiologists physical status (ASAPS) classification I-II
- Absence of Pregnancy
- With inform-consent
Who cannot join
- 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
Show all 9Show fewer
- Drug allergy (NSAIDs, Paracetamol)
- On current medication: corticosteroid
- Psychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low-pressure Pulmonary Recruitment Maneuver to Decrease Post-laparoscopic Shoulder Pain in Gynecologic Surgery: A Double-blind Randomized Placebo Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Gynecologic Disease, Laparoscopic Surgery
- Being tested
- Pulmonary recruitment maneuver
- Keywords
- Low pressure, Pulmonary Recruitment Maneuver, Post-laparoscopic Shoulder Pain
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary recruitment maneuverProcedure or surgery
Using setting pressure form ventilator to increase pulmonary pressure by compress balloon bag 5 times, 5 seconds per time
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary recruitment maneuver 30 cmH2O | Experimental | After laparoscopic surgery has finished in operator room (before moving off trocar), patient 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 this group will be received positive pressure from Pulmonary recruiment maneuver [balloon bag] from anesthesiologist 5 times of setting pressure 30 cmH2O, 5 seconds per time to increase indirect abdominal pressure to release residual gas Receives: Procedure: Pulmonary recruitment maneuver |
| Pulmonary recruitment maneuver 40 cmH2O | Active comparator | After laparoscopic surgery has finished in operator room (before moving off trocar), patient 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 this group will be received positive pressure from Pulmonary recruiment maneuver [balloon bag] from anesthesiologist 5 times of setting pressure 40 cmH2O, 5 seconds per time to increase indirect abdominal pressure to release residual gas Receives: Procedure: Pulmonary recruitment maneuver |
| Control | No intervention | After laparoscopic surgery has finished in operator room (before moving off trocar), patient 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 this group will not be received any positive pressure from Pulmonary recruiment maneuver [balloon bag] from anesthesiologist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
shoulder pain from using PRM 30 cmH2O
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.
Measured: During stay in hospital around 2-3 days
Secondary outcomes (7)
wound pain
evaluate with Visual analogue scale from score 0(no pain) to score 10 (maximum pain)
Measured: During stay in hospital around 2-3 days
shoulder pain from using PRM 40 cmH2O
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.
Measured: During stay in hospital around 2-3 days
Post-operative residue pneumoperitoneum
Residue air volume in abdominal cavity will be measured (Hight from diaphragm to upper border of liver (cm.)) from Chest x-ray PA upright
Measured: after surgery in day 1
Lung complication
Number of participants with complication (incident) such as pneumothorax, Lung atelectasis, Pleural effusion etc. will be recorded
Measured: after surgery in day 1
GI discomfort
number of symptom
Measured: during stay in hospital around 2-3 days
Time to hospital staying
record day which stay in hospital with abnormal condition
Measured: During stay in hospital around 2-3 days
Administered additional analgesics
number of morphine using
Measured: During stay in hospital around 2-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start1 Oct 2020
- Primary completion20 Jul 2021
- Study completion10 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Anon Yodruangwong, Study director, Resident
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642118
- Sponsor's protocol ID
- 147/2563
- Status last verified
- Aug 2020
- First submitted
- 28 Aug 2020
- Last updated
- 13 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-pressure Pulmonary Recruitment Maneuver to Decrease Post-laparoscopic Shoulder Pain in Gynecologic Surgery: A Double-blind Randomized Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT04642118
- Acronym / sponsor ID
- 147/2563
- Conditions
- Gynecologic Disease, Laparoscopic Surgery
- Keywords
- Low pressure, Pulmonary Recruitment Maneuver, Post-laparoscopic Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 24 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pulmonary recruitment maneuver 30 cmH2O | Experimental | Procedure: Pulmonary recruitment maneuverAfter laparoscopic surgery has finished in operator room (before moving off trocar), patient 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 this group will be received positive pressure from Pulmonary recruiment maneuver [balloon bag] from anesthesiologist 5 times of setting pressure 30 cmH2O, 5 seconds per time to increase indirect abdominal pressure to release residual gas |
| Pulmonary recruitment maneuver 40 cmH2O | Active comparator | Procedure: Pulmonary recruitment maneuverAfter laparoscopic surgery has finished in operator room (before moving off trocar), patient 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 this group will be received positive pressure from Pulmonary recruiment maneuver [balloon bag] from anesthesiologist 5 times of setting pressure 40 cmH2O, 5 seconds per time to increase indirect abdominal pressure to release residual gas |
| Control | No intervention | –After laparoscopic surgery has finished in operator room (before moving off trocar), patient 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 this group will not be received any positive pressure from Pulmonary recruiment maneuver [balloon bag] from anesthesiologist. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 65 years
- Anesthesiologists physical status (ASAPS) classification I-II
- Absence of Pregnancy
- With inform-consent
Key exclusion criteria (9 listed)
- Inability to accurately express pain
- Past history of shoulder or lung surgery
- Chronic shoulder problem
- Epigastric pain
- Lung disease such as emphysema or pneumothorax
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary recruitment maneuverUsing setting pressure form ventilator to increase pulmonary pressure by compress balloon bag 5 times, 5 seconds per time | Procedure or surgery | Pulmonary recruitment maneuver 30 cmH2O, Pulmonary recruitment maneuver 40 cmH2O |
Primary outcome
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.
7 secondary outcomes
wound pain
Time frame: During stay in hospital around 2-3 days
shoulder pain from using PRM 40 cmH2O
Time frame: During stay in hospital around 2-3 days
Post-operative residue pneumoperitoneum
Time frame: after surgery in day 1
Lung complication
Time frame: after surgery in day 1
GI discomfort
Time frame: during stay in hospital around 2-3 days
Time to hospital staying
Time frame: During stay in hospital around 2-3 days
Administered additional analgesics
Time frame: During stay in hospital around 2-3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anon Yodruangwong study director
Resident
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary recruitment maneuver in people with Gynecologic Disease and Laparoscopic Surgery, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
shoulder pain from using PRM 30 cmH2O (time frame: During stay in hospital around 2-3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.