Local Anesthetic Concentration and Rebound Pain

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.

Study Overview

• Status: Recruiting
• Conditions: Rebound Pain
• Intervention / Treatment: Other: Reduced concentration of local anesthetic (ropivacaine); Other: Usual concentration of local anesthetic (ropivacaine)

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: Interventional
• Enrollment (Anticipated): 60
• 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

• Korea, Republic of
  • 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: 15 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
total postoperative fentanyl dose	Total dose of fentanyl injected (mcg) through patient controlled analgesia (PCA) for 48 hours after surgery	48 hours after surgery
fentanyl bolus injection time	Number of bolus injection times using patient controlled analgesia (PCA)	48 hours after surgery
Subjective satisfaction	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

• Sponsor: Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2020
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: MED-INT-20-140

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We will provide it when we have a reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No