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NCT Number: NCT05165836

Dexmedetomidine as Adjuvant in Erector Spinae Plane Block After Shoulder Arthroscopy

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.

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Key information

Conditions

Arthroscopy Agnosia Analgesia Erector Spinae Plane Block Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafr El-Sheikh University Hospitals

Kafr ElSheikh, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erector Spinae Plane block without Dexmedetomidine group

Procedure

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.

Erector Spinae Plane block with Dexmedetomidine group

Procedure

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.

Primary outcomes

  1. 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

  1. Post-operative pain score

    Time frame: 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.

  2. Time to first request of rescue analgesia

    Time frame: 24 hours Postoperative

    Time to the first rescue analgesic request (min) will be also recorded.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 21, 2021
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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