The Effect of Intravenous Dexamethasone on Rebound Pain After Interscalene Brachial Plexus Block for Shoulder Surgery

NCT05141461 | Completed

• 1 other identifier: 07-2021/13
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The rebound pain after nerve block could interfere with the patient's recovery and rehabilitation. It is not known how intravenous dexamethasone affects rebound pain. This study aims to evaluate the effect of intravenous dexamethasone on rebound pain after interscalene block for shoulder surgery.

Conditions

Rebound Pain

Keywords

interscalene brachial plexus block; shoulder surgery; dexamethasone

Outcome Measures

Primary Outcomes (2)

• The difference of pain score before and after interscalene block resolution

  The difference in the pain score between when the block is working and when it has resolved. Pain scores (0 = no pain; 10 = worst pain imaginable) using a Numerical Rating Scale (NRS) ranging from 0 to 10.

  First 12 hours after interscalene block effect disappears

• Incidence of rebound pain

  Rebound pain is described as severe pain (NRS ≥ 7)

  One week after surgery

Secondary Outcomes (7)

• Analgesic consumption

  Postoperative 48 hours

• Quality of Recovery 15 Score

  Postoperative day 1 and day 7

• Numeric Rating Scale pain score ( NRS)

  Postoperative 48 hours

• Interscalene block resolution time

  Postoperative 24 hours

• Glucose measurement

  Postoperative 24th hour

Study Arms (2)

Group C

SHAM COMPARATOR

The patients will be received an ultrasound-guided interscalene brachial plexus block with 15 mL bupivacaine 0.5%.

Procedure: Group C

Group Dex

EXPERIMENTAL

The patients will be received an ultrasound-guided interscalene brachial plexus block with 15 mL bupivacaine 0.5% and 5 mg intravenous dexamethasone.

Procedure: Group Dex

Interventions

Group C PROCEDURE

Patients will receive 2 mg midazolam and 50 ug fentanyl for sedation before the block procedure. Each patient will be positioned appropriately, then a high-frequency linear array transducer (13-6 MHz) will be placed in the interscalene region to define the brachial plexus on the short axis. Under sterile conditions, a 50 mm block needle will be advanced into the interscalen area using the in-plane method. After localization and negative aspiration, 15 ML of 5% bupivacaine drug will be injected into the interscalene area. 100 ml of NACI will be given intravenously within 15 minutes. General anesthesia will be performed using 2 mg/kg of propofol and 1-2 µg/kg of fentanyl. Tracheal intubation will be facilitated with 0.6mg/kg rocuronium. Anesthesia will be maintained using 50% oxygen and 2% sevoflurane. Patients will be extubated into the operating room after reversing residual muscle relaxation. A multimodal analgesia regimen will be applied postoperatively.

Group C

Group Dex PROCEDURE

Patients will receive 2 mg midazolam and 50 ug fentanyl for sedation before the block procedure. Each patient will be positioned appropriately, then a high-frequency linear array transducer (13-6 MHz) will be placed in the interscalene region to define the brachial plexus on the short axis. Under sterile conditions, a 50 mm block needle will be advanced into the interscalene area using the in-plane method. After localization and negative aspiration, 15 ML of 5% bupivacaine drug will be injected into the interscalene area. 5 mg dexamethasone intravenously will be given in 100 ml NACI within 15 minutes. General anesthesia will be performed using 2 mg/kg of propofol and 1-2 µg/kg of fentanyl. Tracheal intubation will be facilitated with 0.6mg/kg rocuronium. Anesthesia will be maintained using 50% oxygen and 2% sevoflurane. Patients will be extubated into the operating room after reversing residual muscle relaxation. A multimodal analgesia regimen will be applied postoperatively.

Group Dex

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing shoulder surgery
• Having signed a written informed consent form,
• ASAI-III

You may not qualify if:

• Inadequate indication for interscalene block (Coagulation disorder, local infection of block site, Diaphragmatic paralysis, Allergy to local anesthetics)
• Neuropathic disorder
• Severe cardiopulmonary disease
• Systemic steroid use
• Chronic opioids use
• Stomach ulcer
• Ucontrolled Diabetes
• Psychiatric disorders,
• Pregnancy,
• Severe obesity (body mass index \> 35 kg/m2)

Sponsors & Collaborators

• Karaman Training and Research Hospital: lead

Study Sites (1)

Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

Location

Study Officials

• Betül Başaran, MD,DESA

  Karaman Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study investigators will not be aware of what group the participant belongs to when assessing the patient at post-operative period
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 2, 2021
• Study Start: January 6, 2022
• Primary Completion: May 23, 2022
• Study Completion: May 28, 2022
• Last Updated: June 1, 2022

Record last verified: 2021-10

Locations

TU (1)