Gynecologic DiseasesNCT02811081
Effective Maneuver for Post-laparoscopic Shoulder Pain
A study testing Passive Deflation, Normal Saline Instillation and Normal Saline Instillation + Pulmonary Recruitment 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 estimate the efficacy and safety of combined intervention with the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver for reducing post-laparoscopic 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?
- Passive Deflation, Normal Saline Instillation and Normal Saline Instillation + Pulmonary Recruitment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Jun 2016to 30 Jul 2017
- 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 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
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effective Maneuver to Reduce Shoulder Pain After Laparoscopic Gynecologic Surgery: Randomized Controlled Trial
The aim of this clinical trial is to estimate the efficacy and safety of combined intervention with the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver for reducing post-laparoscopic shoulder pain.
Read the detailed description
Shoulder pain after laparoscopy is common and its probable mechanism is residual carbon dioxide gas after surgery. Both the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver could effectively reduce post-laparoscopic shoulder pain. However, the efficacy and safety of combined intervention with normal saline instillation and pulmonary recruitment maneuver have not been investigated yet. The aim of this clinical trial is to estimate the effectiveness of combined intervention with the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver for reducing post-laparoscopic shoulder pain.
- Conditions
- Gynecologic Diseases
- Being tested
- Passive Deflation, Normal Saline Instillation, Normal Saline Instillation + Pulmonary Recruitment
- 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.
Passive DeflationProcedure or surgery
In the control group, residual carbon dioxide gas was evacuated by the routine method using passive exsufflation through the port site at the end of surgery.
Normal Saline InstillationProcedure or surgery
In the normal saline instillation group, in addition to the routine method, the patients were placed in the Trendelenburg position (30°), isotonic normal saline (20 ml/kg of body weight) was infused in the sub-diaphragmatic region at the end of surgery.
Normal Saline Instillation + Pulmonary RecruitmentProcedure or surgery
In the combined intervention group, in addition to the routine method, the patients were placed in the Trendelenburg position (30°), and a pulmonary recruitment maneuver was performed after instillation of isotonic normal saline (20 ml/kg of body weight) in the sub-diaphragmatic region at the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Passive deflation of residual carbon dioxide Receives: Procedure: Passive Deflation |
| Normal Saline Instillation | Experimental | Instillation of isotonic normal saline in the sub-diaphragmatic region Receives: Procedure: Normal Saline Instillation |
| Combined Intervention | Experimental | Normal Saline Instillation + Pulmonary Recruitment Receives: Procedure: Normal Saline Instillation + Pulmonary Recruitment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder pain evaluated by 10 point visual analogue scale
The pain score was evaluated by 10 point visual analogue scale.
Measured: after two day of procedure
Secondary outcomes (1)
Wound pain evaluated by 10 point visual analogue scale
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 posted23 Jun 2016 (estimated)
- Study start26 Jun 2016
- Primary completion19 Apr 2017
- Study completion30 Jul 2017
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyoungho Ryu, Kangbuk Samsung Hospital
- Investigators
- Taejong Song, MD PhD, Principal investigator, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811081
- Sponsor's protocol ID
- 2016-05-048
- Status last verified
- May 2018
- First submitted
- 21 Jun 2016
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effective Maneuver to Reduce Shoulder Pain After Laparoscopic Gynecologic Surgery: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02811081
- Acronym / sponsor ID
- 2016-05-048
- Conditions
- Gynecologic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- 26 Jun 2016 (actual)
- Primary completion
- 19 Apr 2017 (actual)
- Study completion
- 30 Jul 2017 (actual)
- First posted
- 23 Jun 2016 (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 estimate the efficacy and safety of combined intervention with the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver for reducing post-laparoscopic shoulder pain.
Detailed description
Shoulder pain after laparoscopy is common and its probable mechanism is residual carbon dioxide gas after surgery. Both the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver could effectively reduce post-laparoscopic shoulder pain. However, the efficacy and safety of combined intervention with normal saline instillation and pulmonary recruitment maneuver have not been investigated yet. The aim of this clinical trial is to estimate the effectiveness of combined intervention with the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver for reducing post-laparoscopic 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 |
|---|---|---|
| Control | Experimental | Procedure: Passive DeflationPassive deflation of residual carbon dioxide |
| Normal Saline Instillation | Experimental | Procedure: Normal Saline InstillationInstillation of isotonic normal saline in the sub-diaphragmatic region |
| Combined Intervention | Experimental | Procedure: Normal Saline Instillation + Pulmonary RecruitmentNormal Saline Instillation + Pulmonary Recruitment |
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 |
|---|---|---|
| Passive DeflationIn the control group, residual carbon dioxide gas was evacuated by the routine method using passive exsufflation through the port site at the end of surgery. | Procedure or surgery | Control |
| Normal Saline InstillationIn the normal saline instillation group, in addition to the routine method, the patients were placed in the Trendelenburg position (30°), isotonic normal saline (20 ml/kg of body weight) was infused in the sub-diaphragmatic region at the end of surgery. | Procedure or surgery | Normal Saline Instillation |
| Normal Saline Instillation + Pulmonary RecruitmentIn the combined intervention group, in addition to the routine method, the patients were placed in the Trendelenburg position (30°), and a pulmonary recruitment maneuver was performed after instillation of isotonic normal saline (20 ml/kg of body weight) in the sub-diaphragmatic region at the end of surgery. | Procedure or surgery | Combined Intervention |
Primary outcome
Shoulder pain evaluated by 10 point visual analogue scale
Time frame: after two day of procedure
The pain score was evaluated by 10 point visual analogue scale.
1 secondary outcome
Wound pain evaluated by 10 point visual analogue scale
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 11 May 2018.
- Individual participant dataSharing planned: Undecided
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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 study testing Passive Deflation, Normal Saline Instillation and Normal Saline Instillation + Pulmonary Recruitment 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 11 May 2018. 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.
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 evaluated by 10 point visual analogue scale (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 11 May 2018.