Local Anesthetic Concentration and Rebound Pain

Sponsor

Ajou University School of Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT04457557

Collaborator

(none)

Enrollment

Location

Arms

24.7

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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)	N/A

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 Design

Study Type:

Interventional

Anticipated 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 ropivacaineRandomized 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 :

Jul 10, 2020

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jul 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Rebound pain score [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

total postoperative fentanyl dose [48 hours after surgery]
Total dose of fentanyl injected (mcg) through patient controlled analgesia (PCA) for 48 hours after surgery
fentanyl bolus injection time [48 hours after surgery]
Number of bolus injection times using patient controlled analgesia (PCA)
Subjective satisfaction [48 hours after surgery]
Patient's subjective satisfaction 48 hours after surgery Use visual analogue scale (0=very unsatisfied, 10= very satisfied)

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ajou university school of medicine	Suwon	Gyeonggi-do	Korea, Republic of	16499

Sponsors and Collaborators

Ajou University School of Medicine

Investigators

Principal Investigator: In Kyong Yi, MD, Ajou University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Jul 7, 2020

Last Update Posted:

Feb 18, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ropivacaine

Anesthetics, Local

Anesthetics

Study Results

No Results Posted as of Feb 18, 2022