Local Anesthetic Concentration and Rebound Pain

NCT04457557 | Unknown

• 1 other identifier: MED-INT-20-140
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Rebound Pain

Outcome Measures

Primary Outcomes (1)

• 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

  48 hours after surgery

Secondary Outcomes (3)

• total postoperative fentanyl dose

  48 hours after surgery

• fentanyl bolus injection time

  48 hours after surgery

• Subjective satisfaction

  48 hours after surgery

Study Arms (2)

Low concentration

EXPERIMENTAL

Interscalene block with 0.15% ropivacaine 15 ml

Other: Reduced concentration of local anesthetic (ropivacaine)

Usual concentration

ACTIVE COMPARATOR

Interscalene block with 0.5% ropivacaine 15 ml

Other: Usual concentration of local anesthetic (ropivacaine)

Interventions

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

Low concentration

Usual concentration of local anesthetic (ropivacaine) OTHER

0.5% ropivacaine 15ml

Usual concentration

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective shoulder surgery under general anesthesia and interscalene block for postoperative pain

You may not qualify if:

• Contraindication of interscalene block: pulmonary disease, lung resection history, brachial nerve injury
• Diabetic neuropathy
• Adverse drug reaction history to ropivacaine, fentanyl
• Impaired coagulation

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou university school of medicine

Suwon, Gyeonggi-do, 16499, South Korea

RECRUITING

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• In Kyong Yi, MD

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

In Kyong Yi, MD

CONTACT

+82-31-219-7522; lyrin01@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Only investigator who prepared the local anesthetics knows the group. Nerve block performer and outcome assessor are applied masking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Randomized controlled trial One group received interscalene block with 0.15% of ropivacaine One group received interscalene block with 0.5% of ropivacaine

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 7, 2020
• Study Start: July 10, 2020
• Primary Completion: June 30, 2023
• Study Completion: July 31, 2023
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)