Clinical trial NCT05141461: The Effect of Intravenous Dexamethasone on Rebound Pain After Interscalene Brachial Plexus Block for Shoulder Surgery
Official title: The Effect of Intravenous Dexamethasone on Rebound Pain After Interscalene Brachial Plexus Block for Shoulder Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rebound Pain
Keywords: interscalene brachial plexus block
shoulder surgery
dexamethasone
Lead sponsor: Karaman Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: The difference of pain score before and after interscalene block resolution
timeFrame: First 12 hours after interscalene block effect disappears
measure: Incidence of rebound pain
timeFrame: One week after surgery
Secondary outcomes:
measure: Analgesic consumption
timeFrame: Postoperative 48 hours
measure: Quality of Recovery 15 Score
timeFrame: Postoperative day 1 and day 7
measure: Numeric Rating Scale pain score ( NRS)
timeFrame: Postoperative 48 hours
measure: Interscalene block resolution time
timeFrame: Postoperative 24 hours
measure: Glucose measurement
timeFrame: Postoperative 24th hour
measure: Number of Participants with Surgical infection
timeFrame: Postoperative 14 days
measure: Sleep Quality measured with Likert Scale
timeFrame: One week after surgery
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Training and Research Hospital
Study officials:
affiliation: Karaman Training and Research Hospital
name: Betül Başaran, MD,DESA
role: STUDY_DIRECTOR
References: