Local Anesthetic Concentration and Rebound Pain

Rebound Pain Clinical Trial

Official title:

Evaluation of the Effect of Local Anesthetic Concentration on Rebound Pain After Interscalene Block for Shoulder Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04457557
• Other study ID #: MED-INT-20-140
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2020
• Est. completion date: July 31, 2023

Study information

• Verified date: September 2022
• Source: Ajou University School of Medicine
• Contact: In Kyong Yi, MD
• Phone: +82-31-219-7522
• Email: lyrin01[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Rebound Pain

Intervention

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
• Usual concentration of local anesthetic (ropivacaine)
0.5% ropivacaine 15ml

Locations

Country	Name	City	State
Korea, Republic of	Ajou university school of medicine	Suwon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	total postoperative fentanyl dose	Total dose of fentanyl injected (mcg) through patient controlled analgesia (PCA) for 48 hours after surgery	48 hours after surgery
Secondary	fentanyl bolus injection time	Number of bolus injection times using patient controlled analgesia (PCA)	48 hours after surgery
Secondary	Subjective satisfaction	Patient's subjective satisfaction 48 hours after surgery Use visual analogue scale (0=very unsatisfied, 10= very satisfied)	48 hours after surgery