Local Anesthetic Concentration and Rebound Pain

NCT ID: NCT04457557

Last Updated: 2022-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-10

Study Completion Date

2023-07-31

Brief Summary

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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

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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

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Rebound Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial One group received interscalene block with 0.15% of ropivacaine One group received interscalene block with 0.5% of ropivacaine
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Only investigator who prepared the local anesthetics knows the group. Nerve block performer and outcome assessor are applied masking.

Study Groups

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Low concentration

Interscalene block with 0.15% ropivacaine 15 ml

Group Type EXPERIMENTAL

Reduced concentration of local anesthetic (ropivacaine)

Intervention Type 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

Interscalene block with 0.5% ropivacaine 15 ml

Group Type ACTIVE_COMPARATOR

Usual concentration of local anesthetic (ropivacaine)

Intervention Type OTHER

0.5% ropivacaine 15ml

Interventions

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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

Intervention Type OTHER

Usual concentration of local anesthetic (ropivacaine)

0.5% ropivacaine 15ml

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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In-kyong Yi

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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In Kyong Yi, MD

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Locations

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Ajou university school of medicine

Suwon, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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In Kyong Yi, MD

Role: CONTACT

+82-31-219-7522

Facility Contacts

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In Kyong Yi, MD

Role: primary

+82-10-3012-6972

Yoon Jung Chae, MD

Role: backup

+82-31-219-5689

Other Identifiers

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MED-INT-20-140

Identifier Type: -

Identifier Source: org_study_id

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