Dexmedetomidine as Adjuvant in Erector Spinae Plane Block After Shoulder Arthroscopy

Not Applicable

Completed

• Conditions: Arthroscopy; Erector Spinae Plane Block; Analgesia
• Interventions: Procedure: Erector Spinae Plane block with Dexmedetomidine group; Procedure: Erector Spinae Plane block without Dexmedetomidine group

• Registration Number: NCT05165836
• Lead Sponsor: Kafrelsheikh University

Brief Summary

The aim of this study is to evaluate the effect of adding dexmedetomidine as an adjuvant to bupivacaine in ultrasound (US) guided erector spinae plane block (ESPB) for managing acute postoperative pain in patients undergoing shoulder arthroscopy.

Detailed Description

Shoulder arthroscopy is a common procedure done is orthopedics for many surgical indications as rotator cuff tears, stiffness and instability. This procedure has a well - documented postoperative pain. To improve the outcome after surgery, effective pain control is needed.

There are many postoperative pain management modalities after shoulder arthroscopy including non-steroidal anti-inflammatory drugs, intraarticular injection, regional nerve blocks, patient controlled analgesia and cryotherapy.

The erector spinae plane block (ESPB) is one of the emerging regional techniques for managing postoperative pain. ESPB has been used successfully in many surgeries such as mastectomy, thoracotomies , percutaneous nephrolithotomies, lumbar fusions, hernia repair, cesarean delivery and even in total hip arthroplasty .

ESPB has been successfully used to treat chronic shoulder pain, and the local anesthetic spread was reported to reach the level of C3 when it was performed at T2.

Dexmedetomidine is a very selective α2 adrenoceptor agonist that is tenfold more selective than clonidine. It is a highly flexible medication in anesthetic practice, finding use in an expanding range of clinical circumstances.

Study Timeline

• Study First Submitted: 2021-12-07
• Study First Submitted QC: 2021-12-07
• Study First Posted: 2021-12-21
• Study Start: 2021-12-25
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-10
• Last Update Posted: 2022-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients aged 18-65 years
• Both genders and BMI < 40 kg/m2
• American Society of Anesthesiologists (ASA) physical status I-II
• Patients who are posted for elective shoulder arthroscopy

Exclusion Criteria

• Known allergy to local anesthetics
• Allergy to all opioid medications
• Diagnostic shoulder arthroscopic procedures,
• Patients with chronic opioid use and coagulopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erector Spinae Plane block with Dexmedetomidine group	Erector Spinae Plane block with Dexmedetomidine group	Patients received Ultrasound-guided Erector Spinae Plane block at T2 using 19 ml of bupivacaine 0.25% + 1 mL dexmedetomidine 0.5 µg/kg
Erector Spinae Plane block without Dexmedetomidine group	Erector Spinae Plane block without Dexmedetomidine group	Patients received Ultrasound-guided Erector Spinae Plane block at T2 using 19 ml of bupivacaine 0.25% + 1 mL saline

Primary Outcome Measures

Name	Time	Method
The total rescue morphine (mg) consumption in the first 24 post-operative hours.	24 hours postoperative	Rescue analgesia in the form of 3 mg IV morphine (mg) will be given if the numeric rating scale (NRS) score is ≥ 4 repeated with 10 minutes lockout interval till the numeric rating scale (NRS) score becomes less than 3

Secondary Outcome Measures

Name	Time	Method
Time to first request of rescue analgesia	24 hours Postoperative	Time to the first rescue analgesic request (min) will be also recorded.
Post-operative pain score	24 hours Postoperative	After extubation, patients will be evaluated for pain using a numeric rating scale (NRS) score at 0,3,6,12,24 h for pain that ranged from (0 = no pain) to (10 = the worst imaginable pain). If the score is ≥ 4, rescue analgesia will be given in the form of fentanyl in a dose of 0.5µg/kg by iv route.

Trial Locations

Locations (1)

Kafr El-Sheikh University Hospitals; 🇪🇬 Kafr ElSheikh, Egypt