Pain, PostoperativeNCT04212936
Optimum-pressure for Reducing Postoperative Shoulder-tip Pain in Laparoscopic Cholecystectomy
A study testing Intraabdominal pressure in people with Pain, Postoperative, run by Mahidol University at 1 site in Thailand.
Trial summary
Laparoscopic cholecystectomy (LC) is the standard treatment of gallbladder disease. LC is the common procedure for general surgeons. Although LC is a safe procedure with very low mortality (<1%), it has some associated major morbidity. Bile duct injury is the most serious complication of LC. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Intraabdominal pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteThailand
- Study dates
- 25 Dec 2019to 30 Jun 2022
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age > 15 years
- Elective procedure of laparoscopic cholecystectomy
- Sign to Inform consent
Who cannot join
- Emergency surgery
- Concomitant other procedure performed
- Deny to participant
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Bangkok, 10400
Narongsak Rungsakulkij, M.D., (660)2011527, narongsak.run@mahidol.ac.th
Thanida Janbavonkij, M.D., (660)909851540, Than_bow@hotmail.com
About this study
Official title: Optimum-pressure for Reducing Postoperative Shoulder-tip Pain in Laparoscopic Cholecystectomy, a Prospective Randomized Controlled Trial
Laparoscopic cholecystectomy (LC) is the standard treatment of gallbladder disease. LC is the common procedure for general surgeons. Although LC is a safe procedure with very low mortality (<1%), it has some associated major morbidity. Bile duct injury is the most serious complication of LC. However, there are some postoperative morbidity including shoulder-tip pain. The incidence of shoulder-tip pain is about 15-45%, which might be influencing the patient outcome including length of hospital stay. From the previous studies, one of the important factor associated with this condition is pneumoperitoneum pressure. Thus, the suggestion of the intra-abdominal pressure should be low pressure as about 8 mmHg. However, the optimum pressure for the low-pressure during laparoscopic cholecystectomy is controversial.
Read the detailed description
We designed the prospective randomized controlled trial to comparing the postoperative shoulder tip pain between two low pressure level (8 and 10 mmHg) during laparoscopic cholecystectomy. After the enrolled participant signed the inform consent, the participant was randomly assigned to 8 or 10 mmHg group. The standard procedure of the laparoscopic cholecystectomy was performed by experience surgeons. During the operation, the pressure limit can be adjusted to facilitate the procedure according to the surgeons. Following the operation, the investigator will ask about the shoulder tip pain from the participant during 48 hours. The standard of care including pain medication during postoperative period was performed.
- Conditions
- Pain, Postoperative
- Being tested
- Intraabdominal pressure
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraabdominal pressureProcedure or surgery
Limited intraabdominal pressure during laparoscopic cholecystectomy between 8 and 10 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 8 mmHg pressure group |
| Study group | Experimental | 10 mmHg group Receives: Procedure: Intraabdominal pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder tip pain
The shoulder tip pain was assessed by the investigator during postoperative period unfil 48 hours. The measurement of the outcome, the investigator would ask the participant by the clinical record form and questionnair. The answer of the questionnaire is presence or absence of the shoulder pain or pain around the shoulder and scapular region.
Measured: 48 hours
Secondary outcomes (2)
Change of intra-abdominal pressure
The change of intra-abminal pressure was measure by two parameters. Firstly, the adjustment of the pressure during the operation was recorded by the questionnaire. The answer of the questionnaire is the presence or absence of the intra-abdominal pressure change. Secondly, the maximum intra-abdominal pressure which is the highest pressure used during the operation, is measure by the level of the pressure appearing in the laparoscopic station by mmHg unit.
Measured: Immediately after surgery
Difficulty of the operation
The difficulty level of the operation which evaluated by the surgeons. The measurement of this outcome by the questionnaire.
Measured: Immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start25 Dec 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Narongsak Rungsakulkij, Mahidol University
- Investigators
- Narongsak Rungsakulkij, M.D., Principal investigator, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212936
- Sponsor's protocol ID
- MURA2019/1005
- Status last verified
- Feb 2021
- First submitted
- 23 Dec 2019
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimum-pressure for Reducing Postoperative Shoulder-tip Pain in Laparoscopic Cholecystectomy, a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04212936
- Acronym / sponsor ID
- MURA2019/1005
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 25 Dec 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 30 Dec 2019 (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.
Laparoscopic cholecystectomy (LC) is the standard treatment of gallbladder disease. LC is the common procedure for general surgeons. Although LC is a safe procedure with very low mortality (<1%), it has some associated major morbidity. Bile duct injury is the most serious complication of LC. However, there are some postoperative morbidity including shoulder-tip pain. The incidence of shoulder-tip pain is about 15-45%, which might be influencing the patient outcome including length of hospital stay. From the previous studies, one of the important factor associated with this condition is pneumoperitoneum pressure. Thus, the suggestion of the intra-abdominal pressure should be low pressure as about 8 mmHg. However, the optimum pressure for the low-pressure during laparoscopic cholecystectomy is controversial.
Detailed description
We designed the prospective randomized controlled trial to comparing the postoperative shoulder tip pain between two low pressure level (8 and 10 mmHg) during laparoscopic cholecystectomy. After the enrolled participant signed the inform consent, the participant was randomly assigned to 8 or 10 mmHg group. The standard procedure of the laparoscopic cholecystectomy was performed by experience surgeons. During the operation, the pressure limit can be adjusted to facilitate the procedure according to the surgeons. Following the operation, the investigator will ask about the shoulder tip pain from the participant during 48 hours. The standard of care including pain medication during postoperative period was performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –8 mmHg pressure group |
| Study group | Experimental | Procedure: Intraabdominal pressure10 mmHg group |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 15 years
- Elective procedure of laparoscopic cholecystectomy
- Sign to Inform consent
Key exclusion criteria (3 listed)
- Emergency surgery
- Concomitant other procedure performed
- Deny to participant
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 |
|---|---|---|
| Intraabdominal pressureLimited intraabdominal pressure during laparoscopic cholecystectomy between 8 and 10 mmHg. | Procedure or surgery | Study group |
Primary outcome
Shoulder tip pain
Time frame: 48 hours
The shoulder tip pain was assessed by the investigator during postoperative period unfil 48 hours. The measurement of the outcome, the investigator would ask the participant by the clinical record form and questionnair. The answer of the questionnaire is presence or absence of the shoulder pain or pain around the shoulder and scapular region.
2 secondary outcomes
Change of intra-abdominal pressure
Time frame: Immediately after surgery
Difficulty of the operation
Time frame: Immediately after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Narongsak Rungsakulkij, M.D. principal investigator
Ramathibodi 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 Intraabdominal pressure in people with Pain, Postoperative, run by Mahidol University 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thanida Janbavonkij, M.D. ((660)909851540, Than_bow@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder tip pain (time frame: 48 hours). 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 25 Feb 2021; AzTrials last refreshed its copy on 3 Nov 2026.