Pain, PostoperativeNCT04236323
The Effect of Remifentanil on Rebound Pain
A study testing Not used remifentanil infusion in people with Pain, Postoperative, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators will evaluate the influence of intraoperative remifentanil infusion on the postoperative hyperalgesia in patients receiving rotator cuff repair after brachial plexus block for postoperative analgesia. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Not used remifentanil infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Feb 2020to 7 Jan 2021
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA class I,II,III
- Patients undergoing arthroscopic rotator cuff repair surgery under general anesthesia after interscalen brachial plexus block for post operative analgesia
- Age ranges from 20 to 70
Who cannot join
- Patients who didn't agree to study
- Patients can't control PCA(Patient-Controlled-Analgesia) independently
- Patients who have conciousness disorder or can't express their pain level by NRS(Numeric Rating Scale) system
- Patients who have severe respiratory disease or hepatic failure
- Patinets who have known neuropathy or coagulopathy
- Pregnancy
- Patients with allegies to the drugs used in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Remifentanil on Rebound Pain in Patients Receiving General Anesthesia for Shoulder Arthroplasty After Brachial Plexus Block for Postoperative Pain Control
The investigators will evaluate the influence of intraoperative remifentanil infusion on the postoperative hyperalgesia in patients receiving rotator cuff repair after brachial plexus block for postoperative analgesia.
Read the detailed description
The study will include 68 patients undergoing rotator cuff repair. All patients will receive brachial plexus block for postoperative analgesia, followed by general anesthesia. In the experimental group, remifentanil infusion will not be used intraoperatively, and in the control group, remifentanil will be infused. After surgery, both groups will be given the same postoperative pain management using patient controlled analgesia(PCA), and pain patterns will be assessed using the Numerical rating scale (NRS) at 4 hour intervals for 24 hours. The primary end point of this study is the total dose of PCA medication over 24 hours.
- Conditions
- Pain, Postoperative
- Being tested
- Not used remifentanil infusion
- Keywords
- hyperalgesia, brachial plexus block, remifentanil
- Medical subject headings
- Pain, Postoperative, Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not used remifentanil infusionDrug
Remifentanil is not used during operation
| Study group | Role | What they receive |
|---|---|---|
| not used intraoperative remifentanil infusion | Experimental | Adult patients aged < 70 years and ASA class < III undergoing rotator cuff repair not used intraoperative remifentanil infusion Receives: Drug: Not used remifentanil infusion |
| used intraoperative remifentanil infusion | No intervention | Adult patients aged < 70 years and ASA class < III undergoing rotator cuff repair used intraoperative remifentanil infusion maintaining target concentration of 2-6ng/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total infused dose of patient controlled analgesia(PCA) drug during 24 hours
Total infused dose of patient controlled analgesia(PCA) drug during first 24 hours after rotor cuff repair under general anesthesia
Measured: From end of operation to the 24hours after operation
Secondary outcomes (3)
Numerical Ratings Scale
Degree of pain is assessed using Numerical Ratings Scale at 4 hours for 24 hours after operation. The patients choose one of the digits from 0 to 10, the zero-point is painless, and the ten-point means the one with the most severe pain.
Measured: Pain levels are checked using Numerical Ratings Scale at 4 hour intervals for 24 hours after surgery
Total patient's trial to PCA bolus infusion
The total number of times patients press the infusion button on the PCA to control pain
Measured: 24 hours after surgery
Incidence of postoperative nausea and vomiting
Postoperative nausea and vomiting is assessed at 24hr after surgery by a face-to face interview
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start14 Feb 2020
- Primary completion12 Aug 2020
- Study completion7 Jan 2021
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 Seoul National University 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, MD., PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236323
- Sponsor's protocol ID
- 1912-041-1087
- Status last verified
- May 2021
- First submitted
- 15 Jan 2020
- Last updated
- 1 Jun 2021
- Results posted
- No
- 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 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Remifentanil on Rebound Pain in Patients Receiving General Anesthesia for Shoulder Arthroplasty After Brachial Plexus Block for Postoperative Pain Control
- ClinicalTrials.gov ID
- NCT04236323
- Acronym / sponsor ID
- 1912-041-1087
- Conditions
- Pain, Postoperative
- Keywords
- hyperalgesia, brachial plexus block, remifentanil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 12 Aug 2020 (actual)
- Study completion
- 7 Jan 2021 (actual)
- First posted
- 22 Jan 2020 (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.
The investigators will evaluate the influence of intraoperative remifentanil infusion on the postoperative hyperalgesia in patients receiving rotator cuff repair after brachial plexus block for postoperative analgesia.
Detailed description
The study will include 68 patients undergoing rotator cuff repair. All patients will receive brachial plexus block for postoperative analgesia, followed by general anesthesia. In the experimental group, remifentanil infusion will not be used intraoperatively, and in the control group, remifentanil will be infused. After surgery, both groups will be given the same postoperative pain management using patient controlled analgesia(PCA), and pain patterns will be assessed using the Numerical rating scale (NRS) at 4 hour intervals for 24 hours. The primary end point of this study is the total dose of PCA medication over 24 hours.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| not used intraoperative remifentanil infusion | Experimental | Drug: Not used remifentanil infusionAdult patients aged < 70 years and ASA class < III undergoing rotator cuff repair not used intraoperative remifentanil infusion |
| used intraoperative remifentanil infusion | No intervention | –Adult patients aged < 70 years and ASA class < III undergoing rotator cuff repair used intraoperative remifentanil infusion maintaining target concentration of 2-6ng/ml |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA class I,II,III
- Patients undergoing arthroscopic rotator cuff repair surgery under general anesthesia after interscalen brachial plexus block for post operative analgesia
- Age ranges from 20 to 70
Key exclusion criteria (7 listed)
- Patients who didn't agree to study
- Patients can't control PCA(Patient-Controlled-Analgesia) independently
- Patients who have conciousness disorder or can't express their pain level by NRS(Numeric Rating Scale) system
- Patients who have severe respiratory disease or hepatic failure
- Patinets who have known neuropathy or coagulopathy
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 |
|---|---|---|
| Not used remifentanil infusionRemifentanil is not used during operation | Drug | not used intraoperative remifentanil infusion |
Primary outcome
Total infused dose of patient controlled analgesia(PCA) drug during 24 hours
Time frame: From end of operation to the 24hours after operation
Total infused dose of patient controlled analgesia(PCA) drug during first 24 hours after rotor cuff repair under general anesthesia
3 secondary outcomes
Numerical Ratings Scale
Time frame: Pain levels are checked using Numerical Ratings Scale at 4 hour intervals for 24 hours after surgery
Total patient's trial to PCA bolus infusion
Time frame: 24 hours after surgery
Incidence of postoperative nausea and vomiting
Time frame: 24 hours after surgery
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 Jun 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.
Jin-Tae Kim, MD., PhD principal investigator
Seoul National University 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 Not used remifentanil infusion in people with Pain, Postoperative, run by Seoul National University 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 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 Jun 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 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?
Total infused dose of patient controlled analgesia(PCA) drug during 24 hours (time frame: From end of operation to the 24hours after operation). 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 Jun 2021.