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Local Anesthetic Concentration and Rebound Pain

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ClinicalTrials.gov Identifier: NCT04457557
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : September 30, 2022
Sponsor:
Information provided by (Responsible Party):
In-kyong Yi, Ajou University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Rebound Pain Other: Reduced concentration of local anesthetic (ropivacaine) Other: Usual concentration of local anesthetic (ropivacaine) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Outcomes Assessor)
Masking Description: Only investigator who prepared the local anesthetics knows the group. Nerve block performer and outcome assessor are applied masking.
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of Local Anesthetic Concentration on Rebound Pain After Interscalene Block for Shoulder Surgery
Actual Study Start Date : July 10, 2020
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low concentration
Interscalene block with 0.15% ropivacaine 15 ml
Other: 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

Active Comparator: Usual concentration
Interscalene block with 0.5% ropivacaine 15 ml
Other: Usual concentration of local anesthetic (ropivacaine)
0.5% ropivacaine 15ml




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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

  2. fentanyl bolus injection time [ Time Frame: 48 hours after surgery ]
    Number of bolus injection times using patient controlled analgesia (PCA)

  3. 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)



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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04457557


Contacts
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Contact: In Kyong Yi, MD +82-31-219-7522 lyrin01@gmail.com

Locations
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Korea, Republic of
Ajou university school of medicine Recruiting
Suwon, Gyeonggi-do, Korea, Republic of, 16499
Contact: In Kyong Yi, MD    +82-10-3012-6972    lyrin01@gmail.com   
Contact: Yoon Jung Chae, MD    +82-31-219-5689      
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
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Principal Investigator: In Kyong Yi, MD Ajou University School of Medicine
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Responsible Party: In-kyong Yi, Assistant professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT04457557    
Other Study ID Numbers: MED-INT-20-140
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: September 30, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will provide it when we have a reasonable request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents