Laparoscopic Gynecological SurgeryNCT05489796
Bellomic PCA in Laparoscopic Gynecologic Surgery
A study testing Fentanyl selector, Fentanyl continuous and Ketorolac continuous in people with Laparoscopic Gynecological Surgery, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
In laparoscopic gynecological surgery, when intravenous patient-controlled analgesia (IV-PCA) device is used after surgery, the degree of postoperative side effects and pain control is compared when a combination of fentanyl and ketorolac is administered compared to when fentanyl alone is used. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Laparoscopic Gynecological Surgery
- What is being tested?
- Fentanyl selector, Fentanyl continuous and Ketorolac continuous
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jun 2022to 31 Aug 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 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American society of anesthesiology physical status 1 or 2
- Patients scheduled for gynecological laparoscopic surgery under general anesthesia
- Patients who applied for the use of IV-PCA after surgery
Who cannot join
- Patients with side effects of opioids
- Patients with hypersensitivity to aspirin or non-steroid anti-inflammatory drugs
- Patients with alcohol or drug dependence
- Patients with peptic ulcers, patients with gastrointestinal bleeding
- Patients with suspected cerebrovascular hemorrhage, organic disorders, or damage to the head related to increased intracranial pressure
- Symptoms of bronchial asthma or bronchospasm
Show all 13Show fewer
- Patients with severe respiratory depression
- Moderate to severe renal impairment
- Patients with reduced blood volume or dehydration
- polyps in the nose
- angioedema
- Patients with or a history of the convulsive disease
- Patients for whom the use of neuromuscular blocking agents is contraindicated
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National Univ. Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Comparison of Postoperative Side Effects and Analgesic Quality According to the Combination of Fentanyl and Ketorolac Versus Fentanyl After Laparoscopic Gynecologic Surgery
In laparoscopic gynecological surgery, when intravenous patient-controlled analgesia (IV-PCA) device is used after surgery, the degree of postoperative side effects and pain control is compared when a combination of fentanyl and ketorolac is administered compared to when fentanyl alone is used.
- Conditions
- Laparoscopic Gynecological Surgery
- Being tested
- Fentanyl selector, Fentanyl continuous, Ketorolac continuous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl selectorDrug
Selector (1 ml; Lock out 10 min): Fentanyl 200 mcg + N/S 16 ml = total 20 ml
Fentanyl continuousDrug
Continuous (2 ml/hr): fentanyl 700 mcg + N/S 86 ml = total 100 ml
Ketorolac continuousDrug
Continuous (2 ml/hr): Ketorolac 180 mg + N/S 94 ml = total 100 ml
| Study group | Role | What they receive |
|---|---|---|
| Dual group | Experimental | The two drugs are administered separately. Receives: Drug: Fentanyl selector; Drug: Ketorolac continuous |
| Single group | Active comparator | One drug is administered alone. Receives: Drug: Fentanyl selector; Drug: Fentanyl continuous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the occurrence of postoperative nausea
Confirm the occurrence of postoperative nausea.
Measured: postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour
Change in the occurrence of postoperative vomiting
Confirm the occurrence of postoperative vomiting.
Measured: postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour
Secondary outcomes (3)
Change in the use of rescue antiemetics
Investigate the use of rescue antiemetics.
Measured: postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour
Change of postoperative pain score
Postoperative pain scores are scored on a scale of 0-10.
Measured: postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour
Change in the use of rescue analgesics
Investigate the use of rescue analgesics.
Measured: postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start30 Jun 2022
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Gynecological SurgeryStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489796
- Sponsor's protocol ID
- B-2110-716-003
- Status last verified
- May 2023
- First submitted
- 1 Jul 2022
- Last updated
- 18 May 2023
- 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 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Side Effects and Analgesic Quality According to the Combination of Fentanyl and Ketorolac Versus Fentanyl After Laparoscopic Gynecologic Surgery
- ClinicalTrials.gov ID
- NCT05489796
- Acronym / sponsor ID
- B-2110-716-003
- Conditions
- Laparoscopic Gynecological Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 5 Aug 2022 (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.
In laparoscopic gynecological surgery, when intravenous patient-controlled analgesia (IV-PCA) device is used after surgery, the degree of postoperative side effects and pain control is compared when a combination of fentanyl and ketorolac is administered compared to when fentanyl alone is used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual group | Experimental | Drug: Fentanyl selector, Drug: Ketorolac continuousThe two drugs are administered separately. |
| Single group | Active comparator | Drug: Fentanyl selector, Drug: Fentanyl continuousOne drug is administered alone. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American society of anesthesiology physical status 1 or 2
- Patients scheduled for gynecological laparoscopic surgery under general anesthesia
- Patients who applied for the use of IV-PCA after surgery
Key exclusion criteria (13 listed)
- Patients with side effects of opioids
- Patients with hypersensitivity to aspirin or non-steroid anti-inflammatory drugs
- Patients with alcohol or drug dependence
- Patients with peptic ulcers, patients with gastrointestinal bleeding
- Patients with suspected cerebrovascular hemorrhage, organic disorders, or damage to 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 |
|---|---|---|
| Fentanyl selectorSelector (1 ml; Lock out 10 min): Fentanyl 200 mcg + N/S 16 ml = total 20 ml | Drug | Dual group, Single group |
| Fentanyl continuousContinuous (2 ml/hr): fentanyl 700 mcg + N/S 86 ml = total 100 ml | Drug | Single group |
| Ketorolac continuousContinuous (2 ml/hr): Ketorolac 180 mg + N/S 94 ml = total 100 ml | Drug | Dual group |
Primary outcome
Change in the occurrence of postoperative nausea
Time frame: postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour
Confirm the occurrence of postoperative nausea.
Change in the occurrence of postoperative vomiting
Time frame: postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour
Confirm the occurrence of postoperative vomiting.
3 secondary outcomes
Change in the use of rescue antiemetics
Time frame: postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour
Change of postoperative pain score
Time frame: postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour
Change in the use of rescue analgesics
Time frame: postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour
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 18 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl selector, Fentanyl continuous and Ketorolac continuous in people with Laparoscopic Gynecological Surgery, 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 3 inclusion and 13 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 18 May 2023. 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?
Change in the occurrence of postoperative nausea (time frame: postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour). The study lists 2 primary outcomes in all. 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 18 May 2023.