Rebound PainNCT04457557
Local Anesthetic Concentration and Rebound Pain
A study testing Reduced concentration of local anesthetic (ropivacaine) and Usual concentration of local anesthetic (ropivacaine) in people with Rebound Pain, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
The rebound pain after nerve block could interfere with patient's recovery and rehabilitation. It is not known how local anesthetic concentrations affect rebound pain. The aim of this study is evaluation of the effect of local anesthetic concentration on rebound pain after interscalene block for shoulder surgery. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Rebound Pain
- What is being tested?
- Reduced concentration of local anesthetic (ropivacaine) and Usual concentration of local anesthetic (ropivacaine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jul 2020to 31 Jul 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective shoulder surgery under general anesthesia and interscalene block for postoperative pain
Who cannot join
- Contraindication of interscalene block: pulmonary disease, lung resection history, brachial nerve injury
- Diabetic neuropathy
- Adverse drug reaction history to ropivacaine, fentanyl
- Impaired coagulation
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Ajou university school of medicine
Suwon, Gyeonggi-do, 16499
In Kyong Yi, MD, +82-10-3012-6972, lyrin01@gmail.com
Yoon Jung Chae, MD, +82-31-219-5689
About this study
Official title: Evaluation of the Effect of Local Anesthetic Concentration on Rebound Pain After Interscalene Block for Shoulder Surgery
The rebound pain after nerve block could interfere with patient's recovery and rehabilitation. It is not known how local anesthetic concentrations affect rebound pain. The aim of this study is evaluation of the effect of local anesthetic concentration on rebound pain after interscalene block for shoulder surgery.
Read the detailed description
Shoulder surgery is related to more than moderate pain after surgery. Interscalene nerve block could reduce the postoperative pain effectively. When the effect of nerve block ends, however, rebound pain could appear. The rebound pain could interfere with patient's recovery and rehabilitation.
The mechanism of rebound pain is not well known. One of possible mechanism is that the pain stimulus that was blocked suddenly comes out, and it is perceived as more severe pain. The strength of the block may vary depending on the concentration of the local anesthetic. Therefore, the concentration of local anesthetics could affect rebound pain. The aim of this study is evaluation of the effect of local anesthetic concentration on rebound pain after interscalene block for shoulder surgery.
- Conditions
- Rebound Pain
- Being tested
- Reduced concentration of local anesthetic (ropivacaine), Usual concentration of local anesthetic (ropivacaine)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced concentration of local anesthetic (ropivacaine)Other
Reduced concentration of ropivacaine We usually use 0.5% ropivacaine in our facility. The intervention group used 0.15% ropivacaine 15 ml
Usual concentration of local anesthetic (ropivacaine)Other
0.5% ropivacaine 15ml
| Study group | Role | What they receive |
|---|---|---|
| Low concentration | Experimental | Interscalene block with 0.15% ropivacaine 15 ml Receives: Other: Reduced concentration of local anesthetic (ropivacaine) |
| Usual concentration | Active comparator | Interscalene block with 0.5% ropivacaine 15 ml Receives: Other: Usual concentration of local anesthetic (ropivacaine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebound pain score
It is calculated by subtracting the visual analogue scale (VAS) of pain at the last time when the nerve block was effective from the highest VAS for 12 hours from the time when the nerve block effect disappeared.
VAS of pain: 0=no pain ~ 10=very severe pain
Measured: 48 hours after surgery
Secondary outcomes (3)
total postoperative fentanyl dose
Total dose of fentanyl injected (mcg) through patient controlled analgesia (PCA) for 48 hours after surgery
Measured: 48 hours after surgery
fentanyl bolus injection time
Number of bolus injection times using patient controlled analgesia (PCA)
Measured: 48 hours after surgery
Subjective satisfaction
Patient's subjective satisfaction 48 hours after surgery Use visual analogue scale (0=very unsatisfied, 10= very satisfied)
Measured: 48 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 posted7 Jul 2020
- Study start10 Jul 2020
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rebound PainStudies 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
- Model description
- Randomized controlled trial One group received interscalene block with 0.15% of ropivacaine One group received interscalene block with 0.5% of ropivacaine
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-kyong Yi, Ajou University School of Medicine
- Investigators
- In Kyong Yi, MD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457557
- Sponsor's protocol ID
- MED-INT-20-140
- Status last verified
- Sep 2022
- First submitted
- 30 Jun 2020
- Last updated
- 30 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will provide it when we have a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Local Anesthetic Concentration on Rebound Pain After Interscalene Block for Shoulder Surgery
- ClinicalTrials.gov ID
- NCT04457557
- Acronym / sponsor ID
- MED-INT-20-140
- Conditions
- Rebound Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 7 Jul 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 rebound pain after nerve block could interfere with patient's recovery and rehabilitation. It is not known how local anesthetic concentrations affect rebound pain. The aim of this study is evaluation of the effect of local anesthetic concentration on rebound pain after interscalene block for shoulder surgery.
Detailed description
Shoulder surgery is related to more than moderate pain after surgery. Interscalene nerve block could reduce the postoperative pain effectively. When the effect of nerve block ends, however, rebound pain could appear. The rebound pain could interfere with patient's recovery and rehabilitation.
The mechanism of rebound pain is not well known. One of possible mechanism is that the pain stimulus that was blocked suddenly comes out, and it is perceived as more severe pain. The strength of the block may vary depending on the concentration of the local anesthetic. Therefore, the concentration of local anesthetics could affect rebound pain. The aim of this study is evaluation of the effect of local anesthetic concentration on rebound pain after interscalene block for shoulder surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial One group received interscalene block with 0.15% of ropivacaine One group received interscalene block with 0.5% of ropivacaine
| Arm | Type | Receives |
|---|---|---|
| Low concentration | Experimental | Other: Reduced concentration of local anesthetic (ropivacaine)Interscalene block with 0.15% ropivacaine 15 ml |
| Usual concentration | Active comparator | Other: Usual concentration of local anesthetic (ropivacaine)Interscalene block with 0.5% ropivacaine 15 ml |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective shoulder surgery under general anesthesia and interscalene block for postoperative pain
Key exclusion criteria (4 listed)
- Contraindication of interscalene block: pulmonary disease, lung resection history, brachial nerve injury
- Diabetic neuropathy
- Adverse drug reaction history to ropivacaine, fentanyl
- Impaired coagulation
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 |
|---|---|---|
| Reduced concentration of local anesthetic (ropivacaine)Reduced concentration of ropivacaine We usually use 0.5% ropivacaine in our facility. The intervention group used 0.15% ropivacaine 15 ml | Other | Low concentration |
| Usual concentration of local anesthetic (ropivacaine)0.5% ropivacaine 15ml | Other | Usual concentration |
Primary outcome
Rebound pain score
Time frame: 48 hours after surgery
It is calculated by subtracting the visual analogue scale (VAS) of pain at the last time when the nerve block was effective from the highest VAS for 12 hours from the time when the nerve block effect disappeared. VAS of pain: 0=no pain ~ 10=very severe pain
3 secondary outcomes
total postoperative fentanyl dose
Time frame: 48 hours after surgery
fentanyl bolus injection time
Time frame: 48 hours after surgery
Subjective satisfaction
Time frame: 48 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Individual participant dataSharing planned: No. We will provide it when we have a reasonable request.
Related trials for Rebound Pain
Not yet recruiting
Nerve Block Resolution Time Display and Pain Complaints
Postoperative Pain, Rebound Pain
RecruitingPhase 4
Intravenous Dexamethasone With Single-Shot Versus Continuous Brachial Plexus Block for Rebound Pain After Shoulder Surgery
Pain, Postoperative, Rebound Pain
RecruitingObservational study
Incidence and Clinical Features of Breakthrough Pain After Brachial Plexus Block in Diabetic Patients
Postoperative Pain
RecruitingPhase 4
Effect of Local Anesthetic Concentration on Rebound Pain
Rebound Pain, Shoulder Arthroplasty
Not yet recruitingPhase 4
Effect of Liposomal Bupivacaine on Rebound Pain After Peripheral Nerve Block in Orthopedic Surgery.
Acute Pain, Orthopaedic Surgery
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.
In Kyong Yi, MD principal investigator
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced concentration of local anesthetic (ropivacaine) and Usual concentration of local anesthetic (ropivacaine) in people with Rebound Pain, run by Ajou University School of Medicine 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 1 inclusion and 4 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 30 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact In Kyong Yi, MD (+82-31-219-7522, lyrin01@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rebound pain score (time frame: 48 hours after surgery). 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 30 Sep 2022.