Postoperative Pain, Arthroscopic Shoulder Surgery, Regional Anesthesia
Conditions
Keywords
Superior trunk block, Arthroscopic shoulder surgery, Postoperative analgesia, Intravenous dexamethasone, Intravenous dexmedetomidine, Placebo-controlled trial, Randomized controlled trial, Triple-blind trial, Rebound pain, Numeric Rating Scale, Rescue analgesia, Peripheral nerve block, Bupivacaine, Opioid consumption, Patient satisfaction
Brief summary
This prospective, randomized, placebo-controlled, triple-blind trial will evaluate the effect of adding intravenous dexamethasone to intravenous dexmedetomidine on postoperative analgesia after superior trunk block in adult patients undergoing elective arthroscopic shoulder surgery. All participants will receive ultrasound-guided superior trunk block and standard intravenous dexmedetomidine. Participants will be randomly assigned to receive either intravenous dexamethasone or an equal volume of normal saline placebo before surgery. The main outcome will be the time from completion of the block to the first request for rescue analgesia after surgery. The study will also evaluate postoperative pain scores, rebound pain, opioid consumption, blood glucose levels, hemodynamic changes, postoperative nausea and vomiting, sleep disturbance due to pain, block-related complications, and patient satisfaction.
Detailed description
Effective postoperative analgesia after arthroscopic shoulder surgery is important for patient comfort, early mobilization, and reduction of postoperative complications. Interscalene brachial plexus block is widely used for shoulder surgery; however, it may be associated with hemidiaphragmatic paresis and respiratory complications. Superior trunk block has been proposed as an alternative regional anesthesia technique that may provide effective analgesia with a potentially lower risk of respiratory impairment. Adjuvant agents are frequently used to prolong the duration and improve the quality of analgesia after peripheral nerve blocks. Intravenous dexamethasone has been shown to prolong analgesia and improve postoperative pain control. Dexmedetomidine is another adjuvant agent with sedative and analgesic properties. However, evidence regarding the combined use of intravenous dexamethasone and intravenous dexmedetomidine in patients receiving superior trunk block for arthroscopic shoulder surgery is limited. This study is designed as a prospective, randomized, placebo-controlled, triple-blind clinical trial. Adult patients aged 18 to 65 years, classified as American Society of Anesthesiologists physical status I to III, scheduled for elective arthroscopic shoulder surgery, and eligible for superior trunk block will be included after written informed consent. All patients will receive standard monitoring before block placement. Premedication with intravenous midazolam may be administered for anxiolysis. A superficial cervical plexus block will be performed with 3 mL of 0.5% bupivacaine, followed by ultrasound-guided superior trunk block using 15 mL of 0.5% bupivacaine. Block success will be assessed approximately 20 minutes after block completion using sensory and motor evaluation. Participants will be randomly assigned to one of two groups using a computer-generated randomization sequence and sealed opaque envelopes. In the intervention group, patients will receive standard intravenous dexmedetomidine infusion plus intravenous dexamethasone 0.15 mg/kg. In the control group, patients will receive standard intravenous dexmedetomidine infusion plus an equal volume of 0.9% normal saline placebo. The study drug or placebo will be prepared by an independent staff member who will not be involved in block performance, data collection, or outcome assessment. The patient, block practitioner, postoperative outcome assessor, and statistician will remain blinded to group allocation. All patients will receive a standardized postoperative multimodal analgesia protocol. Intravenous ibuprofen 400 mg will be administered every 8 hours. Intravenous tramadol 50 mg will be used as rescue analgesia when the Numeric Rating Scale pain score is greater than 3 at rest or during passive movement, or when the patient requests additional analgesia. At least 4 hours will be allowed between tramadol doses, and the maximum daily tramadol dose will be limited to 400 mg. The primary outcome is the time from completion of the superior trunk block to the first request for systemic rescue analgesia in the postoperative period. Secondary outcomes include sensory and motor block characteristics, postoperative Numeric Rating Scale pain scores at 4, 8, 12, 24, and 72 hours, incidence of rebound pain, cumulative opioid consumption during the first 24 hours, perioperative blood glucose levels, hemodynamic events requiring treatment, postoperative nausea and vomiting, sleep disturbance due to pain during the first two nights, transient block-related complications such as Horner syndrome, hoarseness or dyspnea, and patient satisfaction at postoperative 72 hours.
Interventions
DRUGIntravenous Dexamethasone
Intravenous dexamethasone 0.15 mg/kg will be administered before surgery to participants assigned to the dexamethasone group, in addition to ultrasound-guided superior trunk block and standard intravenous dexmedetomidine infusion.
DRUGNormal Saline Placebo
An equal volume of 0.9% normal saline placebo will be administered before surgery to participants assigned to the placebo group, in addition to ultrasound-guided superior trunk block and standard intravenous dexmedetomidine infusion.
Intravenous dexmedetomidine 0.5 mcg/kg will be administered as a 30-minute infusion to all participants in both study groups.
PROCEDURESuperior Trunk Block
Ultrasound-guided superior trunk block will be performed in all participants using 15 mL of 0.5% bupivacaine before arthroscopic shoulder surgery. Block success will be assessed approximately 20 minutes after block completion.
Sponsors
Gaziantep City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
This is a triple-blind trial. The study drug or placebo will be prepared by an independent staff member who will not participate in block performance, intraoperative care, postoperative data collection, or statistical analysis. Participants, the anesthesiologist performing the block and administering the study syringe, and the postoperative outcome assessor will be blinded to group allocation. Statistical analysis will be performed using coded groups.
Intervention model description
Participants will be randomly assigned to one of two parallel groups. All participants will receive ultrasound-guided superior trunk block and standard intravenous dexmedetomidine. The intervention group will receive intravenous dexamethasone 0.15 mg/kg, while the control group will receive an equal volume of 0.9% normal saline placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Patients aged 18 to 65 years. Patients classified as American Society of Anesthesiologists physical status I to III. Patients scheduled for elective arthroscopic shoulder surgery. Patients with a body mass index between 18.5 and 35 kg/m². Patients who are able to understand the study protocol and provide written informed consent. \-
Exclusion criteria
Patients younger than 18 years or older than 65 years. Patients classified as American Society of Anesthesiologists physical status IV or higher. Contraindications to peripheral nerve block, including coagulopathy or infection at the block site. Known allergy or contraindication to any of the drugs used in the study. Active gastrointestinal bleeding, history of peptic ulcer disease, or severe renal or hepatic insufficiency. History of chronic analgesic or opioid use. Pregnancy or breastfeeding. Presence of coagulopathy or use of anticoagulant or antiplatelet therapy. Requirement for additional sedation or general anesthesia during surgery. Neurological or psychiatric disease that may affect pain assessment. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first rescue analgesic request | First rescue analgesic request, assessed up to 72 hours postoperatively. T1: Postoperative 4th hour T2: Postoperative 8th hour T3: Postoperative 12th hour T4: Postoperative 48th hour T5: Postoperative 72th hour | The primary outcome is the time from completion of the superior trunk block to the first request for systemic rescue analgesia in the postoperative period. Rescue analgesia will be defined as intravenous tramadol administration when the Numeric Rating Scale pain score is greater than 3 at rest or during passive movement, or when the patient requests additional analgesia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain scores | T1: Postoperative 4th hour T2: Postoperative 8th hour T3: Postoperative 12th hour T4: Postoperative 48th hour T5: Postoperative 72th hour | Postoperative pain intensity will be assessed using the 0-10 Numeric Rating Scale at rest and during passive movement. Higher scores indicate greater pain intensity. |
| Incidence of rebound pain | T1: Postoperative 4th hour T2: Postoperative 8th hour T3: Postoperative 12th hour T4: Postoperative 48th hour T5: Postoperative 72th hour | Rebound pain will be defined as a sudden increase in pain intensity to a Numeric Rating Scale score greater than 7 after resolution of the nerve block. |
| Cumulative opioid consumption | During the first 24 hours postoperatively. | Cumulative opioid consumption during the first 24 postoperative hours will be calculated and recorded as oral morphine equivalent dose in milligrams. |
| Blood glucose levels | T1: postoperative 1st hour T2: postoperative 4th hour. | Blood glucose levels will be measured to evaluate the systemic metabolic effect of intravenous dexamethasone. |
| Hemodynamic events requiring treatment | T0: Perioperative 15th minute T1: Perioperative 60th minute T2: Postoperative 4th hour T3: Postoperative 12th hour T4: Postoperative 48th hour T5: Postoperative 72th hour | The incidence of bradycardia and hypotension requiring pharmacologic treatment will be recorded. Bradycardia and hypotension will be treated according to the study protocol. |
| Patient satisfaction | At postoperative 72 hours. | Patient satisfaction with the anesthesia and block technique will be assessed using a 5-point Likert scale, where 1 indicates very dissatisfied and 5 indicates very satisfied. |
Contacts
CONTACTBekir Suat Kürkçüoğlu, MD
CONTACTSinan Ünsal, MD
PRINCIPAL_INVESTIGATORBekir Suat Kürkçüoğlu, MD
Gaziantep City Hospital
Outcome results
None listed