Role of Dexmedetomidine as Adjuvant With Bupivacaine in Ultrasound-Guided Erector Spinae Plane Block for Postoperative Analgesia After Shoulder Arthroscopy: A Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kafrelsheikh University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The total rescue morphine (mg) consumption in the first 24 post-operative hours.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: Erector Spinae Plane block without Dexmedetomidine group (Procedure)
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
Intervention: Erector Spinae Plane block with Dexmedetomidine group (Procedure)
Outcomes
Primary Outcomes
The total rescue morphine (mg) consumption in the first 24 post-operative hours.
Time Frame: 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 Outcomes
- Time to first request of rescue analgesia(24 hours Postoperative)
- Post-operative pain score(24 hours Postoperative)
Investigators
Mohamed Fouad Algyar
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine
Kafrelsheikh University