The Effect of Intravenous Dexamethasone on Rebound Pain After Interscalene Brachial Plexus Block for Shoulder Surgery
- Conditions
- Rebound Pain
- Registration Number
- NCT05141461
- Lead Sponsor
- Karaman Training and Research Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Undergoing shoulder surgery
- Having signed a written informed consent form,
- ASAI-III
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of rebound pain One week after surgery Rebound pain is described as severe pain (NRS ≥ 7)
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.
- Secondary Outcome Measures
Name Time Method 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
Analgesic consumption Postoperative 48 hours Rescue analgesic consumption in the first 48 hours postoperatively will be recorded.
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.
Number of Participants with Surgical infection Postoperative 14 days Number of Participants diagnosed with surgical infection
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.
Glucose measurement Postoperative 24th hour Glucose measurement
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.
Trial Locations
- Locations (1)
Karaman Training and Research Hospital
🇹🇷Karaman, Turkey
Karaman Training and Research Hospital🇹🇷Karaman, Turkey