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Dexmedetomidine as Adjuvant in Erector Spinae Plane Block After Shoulder Arthroscopy

Role of Dexmedetomidine as Adjuvant With Bupivacaine in Ultrasound-Guided Erector Spinae Plane Block for Postoperative Analgesia After Shoulder Arthroscopy: A Randomized Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05165836
Enrollment
60
Registered
2021-12-21
Start date
2021-12-25
Completion date
2022-08-01
Last updated
2022-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Arthroscopy, Erector Spinae Plane Block

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.

Interventions

PROCEDUREErector Spinae Plane block without Dexmedetomidine group

Block will be performed with an ultrasound machine (Philips CX50 Extreme edition). A 2-5 MH2 curved probe will be positioned transversely to visualize the lateral tip of thoracic vertebrae2 transverse Process. Before surgery with patients in sitting position, the transducer will be positioned longitudinally 3 cm lateral to the thoracic vertebrae2 spinous process. The trapezius, rhomboid major, and erector spinae muscles will be revealed superficial to the shadow of the hyperechoic transverse process. Then, 3ml lidocaine 2% will be used to anesthetize the skin. Using a 20-gauge block needle put in-plane in a cephalad-to-caudad orientation to position the tip into the fascial plane on the deep (anterior) side of the erector spinae muscle, 19 ml of bupivacaine 0.25% + 1 mL saline will be injected. The needle tip's placement will be confirmed by observable fluid spread lifting the erector spinae muscle away from the transverse process's bony shadow.

PROCEDUREErector Spinae Plane block with Dexmedetomidine group

Block will be performed with an ultrasound machine (Philips CX50 Extreme edition). A 2-5 MH2 curved probe will be positioned transversely to visualize the lateral tip of thoracic vertebrae2 transverse Process. Before surgery with patients in sitting position, the transducer will be positioned longitudinally 3 cm lateral to the thoracic vertebrae2 spinous process. The trapezius, rhomboid major, and erector spinae muscles will be revealed superficial to the shadow of the hyperechoic transverse process. Then, 3ml lidocaine 2% will be used to anesthetize the skin. Using a 20-gauge block needle put in-plane in a cephalad-to-caudad orientation to position the tip into the fascial plane on the deep (anterior) side of the erector spinae muscle, 19 ml of bupivacaine 0.25% + 1 mL dexmedetomidine 0.5 µg/kg will be injected. The needle tip's placement will be confirmed by observable fluid spread lifting the erector spinae muscle away from the transverse process's bony shadow.

Sponsors

Kafrelsheikh University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
The total rescue morphine (mg) consumption in the first 24 post-operative hours.24 hours postoperativeRescue 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

MeasureTime frameDescription
Post-operative pain score24 hours PostoperativeAfter 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.
Time to first request of rescue analgesia24 hours PostoperativeTime to the first rescue analgesic request (min) will be also recorded.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026