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

K

Karaman Training and Research Hospital

Status

Completed

Conditions

Rebound Pain

Treatments

Procedure: Group C
Procedure: Group Dex

Study type

Interventional

Funder types

Other

Identifiers

NCT05141461
07-2021/13

Details and patient eligibility

About

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.

Full description

Shoulder rotator cuff repair and acromioplasty are associated with severe postoperative pain. The interscalene block (ISB) is commonly used for this type of surgery, providing analgesia by anesthetizing the nerves that supply the shoulder. Although the nerve block provides extremely effective analgesia for the first 6-8 hours, patients experience severe pain once its effect has been wearing off. Rebound pain is a severe pain that occurs when the effect of a nerve block disappears in a patient during the postoperative period. The purpose of this study is to investigate whether the use of intravenous dexamethasone reduces rebound pain in patients recruiting for shoulder surgery with interscalene brachial plexus blockade.

This study will be conducted as a single-center, prospective, randomized, double-blinded trial in a university hospital. Patients scheduled for elective shoulder surgery will be screened for enrollment in the study. All subjects will undergo ultrasound-guided interscalene nerve block before induction of general anesthesia. They will be randomly assigned into the two groups which use intravenous dexamethasone or not. An anesthesiologist who will perform blocks will not involve in the data collection. Other health care workers who will involve in the evaluation of postoperative pain scores, nausea and vomiting, opioid consumption, quality of Sleep, and Quality of Recovery score will be blinded to the group assignment.

Enrollment

60 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups

Group C
Sham Comparator group
Description:
The patients will be received an ultrasound-guided interscalene brachial plexus block with 15 mL bupivacaine 0.5%.
Treatment:
Procedure: Group C
Group Dex
Experimental group
Description:
The patients will be received an ultrasound-guided interscalene brachial plexus block with 15 mL bupivacaine 0.5% and 5 mg intravenous dexamethasone.
Treatment:
Procedure: Group Dex

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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