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

Rebound Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05141461
• Other study ID #: 07-2021/13
• Status: Completed
• Phase: N/A
• Start date: January 6, 2022
• Est. completion date: May 28, 2022

Study information

• Verified date: October 2021
• Source: Karaman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 28, 2022
• Est. primary completion date: May 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Rebound Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Karaman Training and Research Hospital	Karaman

Sponsors (1)

Lead Sponsor	Collaborator
Karaman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Incidence of rebound pain	Rebound pain is described as severe pain (NRS = 7)	One week after surgery
Secondary	Analgesic consumption	Rescue analgesic consumption in the first 48 hours postoperatively will be recorded.	Postoperative 48 hours
Secondary	Quality of Recovery 15 Score	Quality of Recovery (QoR)-15 survey.Minimum value: 0, Maximum value: 150, higher scores mean better.	Postoperative day 1 and day 7
Secondary	Numeric Rating Scale pain score ( NRS)	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
Secondary	Interscalene block resolution time	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
Secondary	Glucose measurement	Glucose measurement	Postoperative 24th hour
Secondary	Number of Participants with Surgical infection	Number of Participants diagnosed with surgical infection	Postoperative 14 days
Secondary	Sleep Quality measured with Likert Scale	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