Morbid ObesityNCT07051109
Dual-chamber Patient-controlled Analgesia for Postoperative Recovery
A study testing multimodal analgesia via dual-chamber PCA and single regimen (only fentanyl) in people with Morbid Obesity and PCA, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Postoperative nausea and vomiting (PONV) are the most common complications that can occur after general anesthesia. Postoperative use of opioids and morbid obesity have been reported as risk factors of PONV. Read more about this study
- Who is it for?
- Ages 19 to 65 years, women only
- Conditions the study is for
- Morbid Obesity, PCA, Analgesia
- What is being tested?
- multimodal analgesia via dual-chamber PCA and single regimen (only fentanyl)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Oct 2022to 11 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult females aged 19 to 65 years
- American Society of Anesthesiologists physical status (ASA class) 1 to 3
- Patients scheduled for laparoscopic sleeve gastrectomy under general anesthesia
- Patients requesting the use of IV-PCA after surgery
Who cannot join
- Patients with hypersensitivity to the drugs used in this study (Ketorolac, Fentanyl)
- Patients with alcohol or drug dependence, long-term use of opioids or analgesics
- Patients with liver disease or renal failure
- Patients with peptic ulcer, patients with gastrointestinal bleeding predisposition
- Patients with suspected cerebrovascular hemorrhage, organic disorders of the head related to increased intracranial pressure
- Patients with bronchial asthma or bronchospasm symptoms
Show all 10Show fewer
- Patients with severe respiratory depression
- Nasal polyps, angioedema
- Patients with or history of convulsive disease
- Patients for whom the use of neuromuscular blocking agents is contraindicated
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyunggi-do, 13620
Insun Park, M.D./Ph.D., 823178777499, pis121@hanmail.net
About this study
Official title: Comparison of Postoperative Recovery Between Dual-channel Pump for Intravenous Patient-controlled Analgesia(IV-PCA) and Conventional Single-channel Pump After Laparoscopic Sleeve Gastrectomy: a Prospective Randomized Controlled Trial
Postoperative nausea and vomiting (PONV) are the most common complications that can occur after general anesthesia. Postoperative use of opioids and morbid obesity have been reported as risk factors of PONV. In this study, the investigators aimed to compare the degree of postoperative side effects and pain control when an intravenous patient-controlled analgesia combining fentanyl and ketorolac via a dual-chamber device was provided to participants undergoing laparoscopic sleeve gastrectomy.
Read the detailed description
Morbidly obese patients undergoing laparoscopic sleeve gastrectomy experience a relatively high incidence of postoperative nausea and vomiting, but no effective treatment method has been established yet to prevent them. Through this study, the investigators can expect that if a dual-chamber patient-controlled analgesia device can provide effective analgesia while reducing the amount of opioid used, and thus reduce postoperative nausea and vomiting, it can have the effect of increasing the quality of recovery and satisfaction of participants who have undergone laparoscopic sleeve gastrectomy. Furthermore, this dual-chamber patient-controlled analgesia device can be applied to various surgeries and various patient groups who are at risk for postoperative nausea and vomiting, and it is expected that it can be adapted as one of the methods to prevent postoperative nausea and vomiting.
- Conditions
- Morbid Obesity, PCA, Analgesia, PONV
- Being tested
- multimodal analgesia via dual-chamber PCA, single regimen (only fentanyl)
- Medical subject headings
- Obesity, Morbid, Agnosia, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multimodal analgesia via dual-chamber PCADevice
combination of fentanyl and ketorolac through dual-chamber PCA
single regimen (only fentanyl)Device
fentanyl only through dual-chamber PCA
| Study group | Role | What they receive |
|---|---|---|
| dual-chamber PCA | Experimental | Not described Receives: Device: multimodal analgesia via dual-chamber PCA |
| single regimen PCA | Active comparator | Not described Receives: Device: single regimen (only fentanyl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative nausea and vomitting
The Quality of Recovery score 15
Measured: postoperative 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start11 Oct 2022
- Primary completion11 Aug 2025 (estimated)
- Study completion11 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Park InSun, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051109
- Sponsor's protocol ID
- B-2208-775-002
- Status last verified
- Jun 2025
- First submitted
- 12 Jan 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Recovery Between Dual-channel Pump for Intravenous Patient-controlled Analgesia(IV-PCA) and Conventional Single-channel Pump After Laparoscopic Sleeve Gastrectomy: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07051109
- Acronym / sponsor ID
- B-2208-775-002
- Conditions
- Morbid Obesity, PCA, Analgesia, PONV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 11 Aug 2025 (estimated)
- Study completion
- 11 Mar 2026 (estimated)
- First posted
- 3 Jul 2025 (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.
Postoperative nausea and vomiting (PONV) are the most common complications that can occur after general anesthesia. Postoperative use of opioids and morbid obesity have been reported as risk factors of PONV. In this study, the investigators aimed to compare the degree of postoperative side effects and pain control when an intravenous patient-controlled analgesia combining fentanyl and ketorolac via a dual-chamber device was provided to participants undergoing laparoscopic sleeve gastrectomy.
Detailed description
Morbidly obese patients undergoing laparoscopic sleeve gastrectomy experience a relatively high incidence of postoperative nausea and vomiting, but no effective treatment method has been established yet to prevent them. Through this study, the investigators can expect that if a dual-chamber patient-controlled analgesia device can provide effective analgesia while reducing the amount of opioid used, and thus reduce postoperative nausea and vomiting, it can have the effect of increasing the quality of recovery and satisfaction of participants who have undergone laparoscopic sleeve gastrectomy. Furthermore, this dual-chamber patient-controlled analgesia device can be applied to various surgeries and various patient groups who are at risk for postoperative nausea and vomiting, and it is expected that it can be adapted as one of the methods to prevent postoperative nausea and vomiting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dual-chamber PCA | Experimental | Device: multimodal analgesia via dual-chamber PCA |
| single regimen PCA | Active comparator | Device: single regimen (only fentanyl) |
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)
- Adult females aged 19 to 65 years
- American Society of Anesthesiologists physical status (ASA class) 1 to 3
- Patients scheduled for laparoscopic sleeve gastrectomy under general anesthesia
- Patients requesting the use of IV-PCA after surgery
Key exclusion criteria (10 listed)
- Patients with hypersensitivity to the drugs used in this study (Ketorolac, Fentanyl)
- Patients with alcohol or drug dependence, long-term use of opioids or analgesics
- Patients with liver disease or renal failure
- Patients with peptic ulcer, patients with gastrointestinal bleeding predisposition
- Patients with suspected cerebrovascular hemorrhage, organic disorders of the head related to increased intracranial pressure
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 |
|---|---|---|
| multimodal analgesia via dual-chamber PCAcombination of fentanyl and ketorolac through dual-chamber PCA | Device | dual-chamber PCA |
| single regimen (only fentanyl)fentanyl only through dual-chamber PCA | Device | single regimen PCA |
Primary outcome
postoperative nausea and vomitting
Time frame: postoperative 1 day
The Quality of Recovery score 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multimodal analgesia via dual-chamber PCA and single regimen (only fentanyl) in people with Morbid Obesity and PCA, run by Seoul National University Bundang 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 10 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: looking for participants now, as of the sponsor's last update on 3 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Insun Park, M.D./Ph.D. (823178777499, pis121@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative nausea and vomitting (time frame: postoperative 1 day). 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 3 Jul 2025.