Dexmedetomidine as Adjuvant in Erector Spinae Plane Block After Shoulder Arthroscopy

NCT05165836 | Completed

• 1 other identifier: MKSU 40-11-21
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroscopy; Erector Spinae Plane Block; Analgesia

Outcome Measures

Primary Outcomes (1)

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

  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

  24 hours postoperative

Secondary Outcomes (2)

• Post-operative pain score

  24 hours Postoperative

• Time to first request of rescue analgesia

  24 hours Postoperative

Study Arms (2)

Erector Spinae Plane block without Dexmedetomidine group

PLACEBO COMPARATOR

Patients received Ultrasound-guided Erector Spinae Plane block at T2 using 19 ml of bupivacaine 0.25% + 1 mL saline

Procedure: Erector Spinae Plane block without Dexmedetomidine group

Erector Spinae Plane block with Dexmedetomidine group

EXPERIMENTAL

Patients received Ultrasound-guided Erector Spinae Plane block at T2 using 19 ml of bupivacaine 0.25% + 1 mL dexmedetomidine 0.5 µg/kg

Procedure: Erector Spinae Plane block with Dexmedetomidine group

Interventions

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 without Dexmedetomidine group

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.

Erector Spinae Plane block with Dexmedetomidine group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafr El-Sheikh University Hospitals

Kafr ElSheikh, Egypt

Location

Related Publications (1)

• Hamed MA, Fargaly OS, Abdelghaffar RA, Moussa MA, Algyar MF. The role of dexmedetomidine as an adjuvant for high-thoracic erector spinae plane block for analgesia in shoulder arthroscopy; a randomized controlled study. BMC Anesthesiol. 2023 Feb 15;23(1):53. doi: 10.1186/s12871-023-02014-2.

  PMID: 36793000 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 21, 2021
• Study Start: December 25, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year after the end of the study

Locations

EG (1)