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IRCT20091117002723N6 IRCT 2025-06-20 Shiraz University of Medical Sciences Effect of Local Anesthetic Injection Near Shoulder Nerves on Pain Reduction for Cuff Repair Surgery Effect of Interscalene Nerve Block on Pain Control After Rotator Cuff Repair Surgery in the First Two Weeks-Interventional - Randomized controlled clinical trial 2025-10-01 anticipated 156 Complete https://irct.ir/trial/84168 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned into two groups using block randomization. In this method, blocks of sizes 4, 6, and 8 are generated, each containing an equal number of patients allocated to groups A and B in alternating permutations. Patients are then randomly and equally distributed into the two groups based on these permuted blocks. The block sequences will be generated using the website www.sealedenvelope.com, Blinding description: In the operating room, The pain service anesthesiologist will perform only the nerve block and general anesthesia, while another independent anesthesiologist, blinded to randomization and anesthesia results, will only review and record the study variables. This study is single-blind. 3 Rotator cuff tear. Intervention 1: Group 1(Intervention Group): Patients in this group will receive an interscalene nerve block performed by an anesthesiologist prior to surgery. The block will be administered at the C6 vertebral level, targeting the anterior and middle scalene muscles under ultrasound guidance. A total of 20 mL of 0.5% bupivacaine will be injected. The correct placement of the block will be confirmed by eliciting a brief contraction of the deltoid muscle using a nerve stimulator. In addition to the nerve block, patients will receive 600 mg oral Gabapentin for two weeks postoperatively. Upon arrival in the operating room, all patients will undergo comprehensive monitoring including pulse oximetry, electrocardiogram, and non-invasive blood pressure measurement. Following the nerve block, anesthesia induction will be performed uniformly for all patients. Intervention 2: Group 2(Control Group): Patients in this group will receive 600 mg oral Gabapentin for two weeks postoperatively without undergoing the interscalene nerve block. Similar to the intervention group, these patients will be monitored upon arrival in the operating room with pulse oximetry, electrocardiogram, and non-invasive blood pressure monitoring. Anesthesia induction will be conducted identically to that of the intervention group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is against our policy.
public Seyed Ali Hadavi
Anesthesiology Department, Faghihi Hospital, Zand Street.
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 sahadavi@gmail.com Shiraz University of Medical Sciences scientific Seyed Mohammad Reza Hadavi
Anesthesiology Department, Faghihi Hospital, Zand Street.
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 hadavimr@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Adult patients with ASA grade I or II (American Society of Anesthesiology classification) Patients between 18 and 65 years old Patients candidates for open rotator cuff repair surgery Tendon retraction measuring 2 centimeters or more Consent to participate in the study 18 years 65 years Both Allergy to the drugs used in the study Positive history of Heart, respiratory, kidney diseases and addiction Pregnancy M75.1 Rotator cuff tear or rupture, not specified as traumatic Treatment - Drugs Treatment - Drugs Group 1(Intervention Group): Patients in this group will receive an interscalene nerve block performed by an anesthesiologist prior to surgery. The block will be administered at the C6 vertebral level, targeting the anterior and middle scalene muscles under ultrasound guidance. A total of 20 mL of 0.5% bupivacaine will be injected. The correct placement of the block will be confirmed by eliciting a brief contraction of the deltoid muscle using a nerve stimulator. In addition to the nerve block, patients will receive 600 mg oral Gabapentin for two weeks postoperatively. Upon arrival in the operating room, all patients will undergo comprehensive monitoring including pulse oximetry, electrocardiogram, and non-invasive blood pressure measurement. Following the nerve block, anesthesia induction will be performed uniformly for all patients. Group 2(Control Group): Patients in this group will receive 600 mg oral Gabapentin for two weeks postoperatively without undergoing the interscalene nerve block. Similar to the intervention group, these patients will be monitored upon arrival in the operating room with pulse oximetry, electrocardiogram, and non-invasive blood pressure monitoring. Anesthesia induction will be conducted identically to that of the intervention group. Pain. Timepoint: The pain score is recorded at 6 hours, 12 hours, 24 hours, 48 hours, 1 week, 10 days, and 2 weeks after surgery. Method of measurement: Questionnaire and Numerical Pain Rating Scale (NRS). Shiraz University of Medical Sciences Approved 2025-05-21 Ethics Committee of Shiraz Medical School 3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd. Shiraz Fars Iran (Islamic Republic of)