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Dexmedetomidine as Adjuvant in Erector Spinae Plane Block After Shoulder Arthroscopy

K

Kafrelsheikh University

Status

Completed

Conditions

Arthroscopy
Erector Spinae Plane Block
Analgesia

Treatments

Procedure: Erector Spinae Plane block without Dexmedetomidine group
Procedure: Erector Spinae Plane block with Dexmedetomidine group

Study type

Interventional

Funder types

Other

Identifiers

NCT05165836
MKSU 40-11-21

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups, including a placebo group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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