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

NCT ID: NCT05141461

Last Updated: 2022-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-06
• Study Completion Date: 2022-05-28

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.

Conditions

Rebound Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group C

The patients will be received an ultrasound-guided interscalene brachial plexus block with 15 mL bupivacaine 0.5%.

Group Type: SHAM_COMPARATOR

Group C

Intervention Type: PROCEDURE

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

The patients will be received an ultrasound-guided interscalene brachial plexus block with 15 mL bupivacaine 0.5% and 5 mg intravenous dexamethasone.

Group Type: EXPERIMENTAL

Group Dex

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karaman Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Betül Başaran, MD,DESA

Role: STUDY_DIRECTOR

Karaman Training and Research Hospital

Locations

Karaman Training and Research Hospital

Karaman, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

07-2021/13

Identifier Type: -

Identifier Source: org_study_id