Gynecologic DiseasesPhase 3NCT02596425
Pulmonary Recruitment Maneuver for Postlaparoscopic Shoulder Pain
A Phase 3 study testing 40 cmH2O, 60 cmH2O and Passive deflation in people with Gynecologic Diseases, run by Kangbuk Samsung Hospital at 1 site in South Korea.
Trial summary
The aim of this clinical trial is to evaluate the efficacy and safety of different recruitment maneuvers for reducing postlaparoscopic shoulder pain. Read more about this study
- Who is it for?
- Ages 19 to 65 years, women only
- Conditions the study is for
- Gynecologic Diseases
- What is being tested?
- 40 cmH2O, 60 cmH2O and Passive deflation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2015to May 2016
- Phase
- Phase 3
- 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 19 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing laparoscopy for benign gynecologic diseases
- patients aged 19-65 years
- patients with american society of anesthesiology physical status I-II
- patients obtaining written informed consent
Who cannot join
- patients with chronic shoulder pain, chronic epigastric pain or chronic pain syndrome
- patients with past history of pneumothorax or any pulmonary surgical history
- patients with any shoulder surgery histories
- patients who required to conversion to open surgery from laparoscopic surgery
- patients who required to receive incidental upper abdominal surgeries due to adhesion and injury at upper abdominal cavity
- patients with inability to understand or express 10 point visual analogue scale
- intrauterine pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulmonary Recruitment Maneuver to Reduce Postlaparoscopic Shoulder Pain: Randomized Controlled Trial
The aim of this clinical trial is to evaluate the efficacy and safety of different recruitment maneuvers for reducing postlaparoscopic shoulder pain.
Read the detailed description
Shoulder pain after laparoscopy is common and its probable mechanism is residual CO2 gas after surgery. The pulmonary recruitment maneuver can mechanically remove residual CO2 and reduce pain. In literature, there are two different recruitment maneuvers, which was manual inflation of the lungs with positive pressure ventilation of either 40cmH2O or 60cmH2O at the end of surgery. However, the higher positive pressure may be associated with more chance of barotrauma. Therefore, it is important to determine the lowest effective pressure for reducing postlaparoscopic shoulder pain. The aim of this clinical trial is to evaluate the efficacy and safety of different recruitment maneuvers (40cmH2O or 60cmH2O) for reducing postlaparoscopic shoulder pain.
- Conditions
- Gynecologic Diseases
- Being tested
- 40 cmH2O, 60 cmH2O, Passive deflation
- 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.
40 cmH2OProcedure or surgery
The intervention was five manual inflations of the lungs with positive pressure ventilation of 40 cmH2O at the end of surgery.
60 cmH2OProcedure or surgery
The intervention was five manual inflations of the lungs with positive pressure ventilation of 60 cmH2O at the end of surgery.
Passive deflationProcedure or surgery
In the controls, CO2 was removed by the traditional passive deflation of abdominal cavity.
| Study group | Role | What they receive |
|---|---|---|
| Passive deflation | Experimental | In the controls, CO2 was removed by the traditional passive deflation of abdominal cavity. Receives: Procedure: Passive deflation |
| 40 cmH2O | Experimental | The intervention was five manual inflations of the lungs with positive pressure ventilation of 40 cmH2O at the end of surgery. Receives: Procedure: 40 cmH2O |
| 60 cmH2O | Experimental | The intervention was five manual inflations of the lungs with positive pressure ventilation of 60 cmH2O at the end of surgery. Receives: Procedure: 60 cmH2O |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder pain
The pain score was evaluated by 10 point visual analogue scale.
Measured: after two day of procedure
Secondary outcomes (1)
Wound pain
The pain score was evaluated by 10 point visual analogue scale.
Measured: after two day of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic DiseasesStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taejong Song, Kangbuk Samsung Hospital
- Investigators
- Taejong Song, MD PhD, Principal investigator, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596425
- Sponsor's protocol ID
- 2015-08-007
- Status last verified
- Nov 2016
- First submitted
- 2 Nov 2015
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Recruitment Maneuver to Reduce Postlaparoscopic Shoulder Pain: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02596425
- Acronym / sponsor ID
- 2015-08-007
- Conditions
- Gynecologic Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 4 Nov 2015 (estimated)
- 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.
The aim of this clinical trial is to evaluate the efficacy and safety of different recruitment maneuvers for reducing postlaparoscopic shoulder pain.
Detailed description
Shoulder pain after laparoscopy is common and its probable mechanism is residual CO2 gas after surgery. The pulmonary recruitment maneuver can mechanically remove residual CO2 and reduce pain. In literature, there are two different recruitment maneuvers, which was manual inflation of the lungs with positive pressure ventilation of either 40cmH2O or 60cmH2O at the end of surgery. However, the higher positive pressure may be associated with more chance of barotrauma. Therefore, it is important to determine the lowest effective pressure for reducing postlaparoscopic shoulder pain. The aim of this clinical trial is to evaluate the efficacy and safety of different recruitment maneuvers (40cmH2O or 60cmH2O) for reducing postlaparoscopic shoulder pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Passive deflation | Experimental | Procedure: Passive deflationIn the controls, CO2 was removed by the traditional passive deflation of abdominal cavity. |
| 40 cmH2O | Experimental | Procedure: 40 cmH2OThe intervention was five manual inflations of the lungs with positive pressure ventilation of 40 cmH2O at the end of surgery. |
| 60 cmH2O | Experimental | Procedure: 60 cmH2OThe intervention was five manual inflations of the lungs with positive pressure ventilation of 60 cmH2O at the end of surgery. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients undergoing laparoscopy for benign gynecologic diseases
- patients aged 19-65 years
- patients with american society of anesthesiology physical status I-II
- patients obtaining written informed consent
Key exclusion criteria (7 listed)
- patients with chronic shoulder pain, chronic epigastric pain or chronic pain syndrome
- patients with past history of pneumothorax or any pulmonary surgical history
- patients with any shoulder surgery histories
- patients who required to conversion to open surgery from laparoscopic surgery
- patients who required to receive incidental upper abdominal surgeries due to adhesion and injury at upper abdominal cavity
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 |
|---|---|---|
| 40 cmH2OThe intervention was five manual inflations of the lungs with positive pressure ventilation of 40 cmH2O at the end of surgery. | Procedure or surgery | 40 cmH2O |
| 60 cmH2OThe intervention was five manual inflations of the lungs with positive pressure ventilation of 60 cmH2O at the end of surgery. | Procedure or surgery | 60 cmH2O |
| Passive deflationIn the controls, CO2 was removed by the traditional passive deflation of abdominal cavity. | Procedure or surgery | Passive deflation |
Primary outcome
Shoulder pain
Time frame: after two day of procedure
The pain score was evaluated by 10 point visual analogue scale.
1 secondary outcome
Wound pain
Time frame: after two day of procedure
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 1 Dec 2016.
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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.
Taejong Song, MD PhD principal investigator
Kangbuk Samsung Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 40 cmH2O, 60 cmH2O and Passive deflation in people with Gynecologic Diseases, run by Kangbuk Samsung Hospital at 1 site in South Korea.
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 7 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 1 Dec 2016. 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 South Korea. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (time frame: after two day of procedure). 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 1 Dec 2016.