- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05141461
The Effect of Intravenous Dexamethasone on Rebound Pain After Interscalene Brachial Plexus Block for Shoulder Surgery
The Effect of Intravenous Dexamethasone on Rebound Pain After Interscalene Brachial Plexus Block for Shoulder Surgery: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Karaman, Turkey, 70200
- Karaman Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Group C
The patients will be received an ultrasound-guided interscalene brachial plexus block with 15 mL bupivacaine 0.5%.
|
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. |
Experimental: Group Dex
The patients will be received an ultrasound-guided interscalene brachial plexus block with 15 mL bupivacaine 0.5% and 5 mg intravenous dexamethasone.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The difference of pain score before and after interscalene block resolution
Time Frame: First 12 hours after interscalene block effect disappears
|
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
Time Frame: One week after surgery
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Rebound pain is described as severe pain (NRS ≥ 7)
|
One week after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose measurement
Time Frame: Postoperative 24th hour
|
Glucose measurement
|
Postoperative 24th hour
|
Analgesic consumption
Time Frame: Postoperative 48 hours
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Rescue analgesic consumption in the first 48 hours postoperatively will be recorded.
|
Postoperative 48 hours
|
Quality of Recovery 15 Score
Time Frame: Postoperative day 1 and day 7
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Quality of Recovery (QoR)-15 survey.Minimum value: 0, Maximum value: 150, higher scores mean better.
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Postoperative day 1 and day 7
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Numeric Rating Scale pain score ( NRS)
Time Frame: Postoperative 48 hours
|
Pain scores (0 = no pain; 10 = worst pain imaginable) using a Numerical Rating Scale (NRS) ranging from 0 to 10.
It will be recorded at the 2nd, 4th, 6th, 8th, 12th, 16th, 18th, and 24th hours in the postoperative period
|
Postoperative 48 hours
|
Interscalene block resolution time
Time Frame: Postoperative 24 hours
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The time of the first analgesic request.
If the patient will not need analgesic, the block will be accepted as resolved when numbness or heaviness will not be felt by the patient.
|
Postoperative 24 hours
|
Number of Participants with Surgical infection
Time Frame: Postoperative 14 days
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Number of Participants diagnosed with surgical infection
|
Postoperative 14 days
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Sleep Quality measured with Likert Scale
Time Frame: One week after surgery
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Patients' perceived sleep quality will be assessed with a Likert scale.
Likert scale is scored from Likert scale where 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied and 5 = very satisfied.
|
One week after surgery
|
Collaborators and Investigators
Investigators
- Study Director: Betül Başaran, MD,DESA, Karaman Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 07-2021/13
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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