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

Sponsor

Karaman Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05141461

Collaborator

(none)

Enrollment

Location

Arms

4.7

Actual Duration (Months)

12.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rebound Pain	Procedure: Group C Procedure: Group Dex	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Study investigators will not be aware of what group the participant belongs to when assessing the patient at post-operative period

Primary Purpose:

Treatment

Official Title:

The Effect of Intravenous Dexamethasone on Rebound Pain After Interscalene Brachial Plexus Block for Shoulder Surgery: a Randomized Controlled Trial

Actual Study Start Date :

Jan 6, 2022

Actual Primary Completion Date :

May 23, 2022

Actual Study Completion Date :

May 28, 2022

Arms and Interventions

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%.	Procedure: Group C 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.	Procedure: Group Dex 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.

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%.

Procedure: Group C

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.

Procedure: Group Dex

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.

Outcome Measures

Primary Outcome Measures

The difference of pain score before and after interscalene block resolution [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.
Incidence of rebound pain [One week after surgery]
Rebound pain is described as severe pain (NRS ≥ 7)

Secondary Outcome Measures

Analgesic consumption [Postoperative 48 hours]
Rescue analgesic consumption in the first 48 hours postoperatively will be recorded.
Quality of Recovery 15 Score [Postoperative day 1 and day 7]
Quality of Recovery (QoR)-15 survey.Minimum value: 0, Maximum value: 150, higher scores mean better.
Numeric Rating Scale pain score ( NRS) [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
Interscalene block resolution time [Postoperative 24 hours]
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.
Glucose measurement [Postoperative 24th hour]
Glucose measurement
Number of Participants with Surgical infection [Postoperative 14 days]
Number of Participants diagnosed with surgical infection
Sleep Quality measured with Likert Scale [One week after surgery]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karaman Training and Research Hospital	Karaman		Turkey	70200

Sponsors and Collaborators

Karaman Training and Research Hospital

Investigators

Study Director: Betül Başaran, MD,DESA, Karaman Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Karaman Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT05141461

Other Study ID Numbers:

07-2021/13

First Posted:

Dec 2, 2021

Last Update Posted:

Jun 1, 2022

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Karaman Training and Research Hospital

interscalene brachial plexus block

shoulder surgery

dexamethasone

Study Results

No Results Posted as of Jun 1, 2022