- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04457557
Local Anesthetic Concentration and Rebound Pain
Evaluation of the Effect of Local Anesthetic Concentration on Rebound Pain After Interscalene Block for Shoulder Surgery
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: In Kyong Yi, MD
- Phone Number: +82-31-219-7522
- Email: lyrin01@gmail.com
Study Locations
-
-
Gyeonggi-do
-
Suwon, Gyeonggi-do, Korea, Republic of, 16499
- Recruiting
- Ajou University School of Medicine
-
Contact:
- Yoon Jung Chae, MD
- Phone Number: +82-31-219-5689
-
Contact:
- In Kyong Yi, MD
- Phone Number: +82-10-3012-6972
- Email: lyrin01@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Elective shoulder surgery under general anesthesia and interscalene block for postoperative pain
Exclusion Criteria:
- Contraindication of interscalene block: pulmonary disease, lung resection history, brachial nerve injury
- Diabetic neuropathy
- Adverse drug reaction history to ropivacaine, fentanyl
- Impaired coagulation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low concentration
Interscalene block with 0.15% ropivacaine 15 ml
|
Reduced concentration of ropivacaine We usually use 0.5% ropivacaine in our facility.
The intervention group used 0.15% ropivacaine 15 ml
|
Active Comparator: Usual concentration
Interscalene block with 0.5% ropivacaine 15 ml
|
0.5% ropivacaine 15ml
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
48 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
total postoperative fentanyl dose
Time Frame: 48 hours after surgery
|
Total dose of fentanyl injected (mcg) through patient controlled analgesia (PCA) for 48 hours after surgery
|
48 hours after surgery
|
fentanyl bolus injection time
Time Frame: 48 hours after surgery
|
Number of bolus injection times using patient controlled analgesia (PCA)
|
48 hours after surgery
|
Subjective satisfaction
Time Frame: 48 hours after surgery
|
Patient's subjective satisfaction 48 hours after surgery Use visual analogue scale (0=very unsatisfied, 10= very satisfied)
|
48 hours after surgery
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MED-INT-20-140
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rebound Pain
-
Karaman Training and Research HospitalCompleted
-
Beijing Tiantan HospitalNot yet recruitingDexamethasone | Thoracoscopic Surgery | Rebound Pain | Intercostal Nerve BlockChina
-
Federal University of UberlandiaCompleted
-
Inonu UniversityUnknownThe Effects of Remifentanil on Attenuating the Hemodynamic Responses After Electroconvulsive TherapyHaemodynamic ReboundTurkey
-
CMH JhelumCompletedHemodynamic ReboundPakistan
-
Hospital Universitario Doctor PesetRecruitingOutpatient Surgery | Foot Surgery | Rebound Pain | Sciatic Nerve BlockSpain
-
Universitätsklinikum Hamburg-EppendorfCompletedFluid Overload | Bloodpressure | Volume Overload | Hemodynamic Rebound
-
University of ZurichCompleted
-
Northern Orthopaedic Division, DenmarkAalborg UniversityCompleted
-
The New England Center for Headache, P.C.Ortho-McNeil Neurologics, Inc.UnknownAnalgesic Rebound HeadacheUnited States
Clinical Trials on Reduced concentration of local anesthetic (ropivacaine)
-
Pusan National University HospitalCompletedHemodynamics | Epidural Anesthesia | Ropivacaine ConcentrationKorea, Republic of
-
University of TorontoRecruitingArthroplasty, Replacement, HipCanada
-
University of California, San DiegoEnrolling by invitationTrauma Injury | Pain, Acute PostoperativeUnited States
-
Seoul National University HospitalRecruitingDiabetic Foot | Diabetic NeuropathiesKorea, Republic of
-
University Hospital, BordeauxTerminated
-
University of New MexicoTerminated
-
University of California, San DiegoRecruitingAnesthesia, Local | Acute Pain | Anesthesia | Hepatic ResectionUnited States
-
General Hospital of Ningxia Medical UniversityUnknown
-
Francesco MongelliCompleted
-
Karlstad Central HospitalCompleted