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IRCT20250609066132N1 IRCT 2025-07-07 Shiraz University of Medical Sciences Comparison of Two Pain Control Methods After Chest Surgery: Anterior Rib Muscle Block Injection versus Continuous Infusion of the Anesthetic Drug Ketodex Comparison serratus anterior block versus intraoperative continuous infusion of ketodex in acute pain management of thoracotomy-Randomized clinical trial 2025-07-21 anticipated 50 Complete https://irct.ir/trial/84201 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be assigned to two groups using block randomization. In this method, blocks of sizes 4 and 6 are created, each containing an equal number of patients from groups A and B arranged in alternating permutations. Then, 10 blocks are randomly selected, and patients are allocated equally and randomly to the two groups according to the sequences within these blocks. The block randomization sequence will be generated using the website www.sealedenvelope.com, Blinding description: This study is designed as a double-blind trial. Patients are under general anesthesia during the interventions and are unaware of their group allocation. The only individual aware of the group assignments is the anesthesiologist performing the interventions, who does not participate in clinical assessments or data analysis. Additionally, the clinical assessor responsible for data collection and outcome evaluation, as well as the statistical analyst who processes and analyzes the data, are fully blinded to the patients’ group allocations. 2-3 Thoracotomy. Intervention 1: Intervention Group (Serratus Anterior Block - SAB):Participants in the SAB group will receive an ultrasound-guided serratus anterior block immediately after anesthesia induction. Using a 22-gauge, 50 mm needle and in the lateral decubitus position, 20 ml of 0.25% Bupivacaine will be injected at the mid-axillary line at the level of the fifth rib, between the serratus anterior muscle and the intercostal muscles on the operative side. This procedure will be performed under sterile conditions with close monitoring for any signs of systemic local anesthetic toxicity prior to the surgical incision. It is noteworthy that the anesthesia induction, maintenance, and all perioperative care will be conducted identically and according to a standardized protocol in both groups. Intervention 2: Control Group (Continuous Infusion of Ketodex - ICK):Participants in the ICK group will receive a continuous intravenous infusion of ketamine and Dexmedetomidine immediately after anesthesia induction. Ketamine will be infused at a rate of 5 to 7.5 mcg/kg/min, and Dexmedetomidine at 0.3 to 1 mcg/kg/hour through a single intravenous line under the supervision of an anesthesiology specialist. It is important to note that anesthesia induction, maintenance, and all perioperative care will be conducted identically and according to a standardized protocol in both groups. 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 Shadi Oboodi
Anesthesia Department- Operation Room- Nemazee Hospital- Zande Blvd.
Shiraz Iran (Islamic Republic of) 7193711351 +98 71 3628 1460 sh_oboudi@yahoo.com Shiraz University of Medical Sciences scientific Fateme Khalili
Anesthesia Department- Operation Room- Nemazee Hospital- Zande Blvd.
Shiraz Iran (Islamic Republic of) 7193711351 +98 71 3628 1460 khalili_fa@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Adult patients aged 18 years and older Candidates scheduled for elective thoracotomy Ability to provide informed and voluntary consent to participate in the study 18 years no limit Both Allergy to study medications Coagulation disorders or use of anticoagulants Psychiatric or cognitive disorders affecting informed consent Chronic use of opioids or analgesics History of previous chest surgery S27.0 Traumatic pneumothorax Treatment - Drugs Treatment - Drugs Intervention Group (Serratus Anterior Block - SAB):Participants in the SAB group will receive an ultrasound-guided serratus anterior block immediately after anesthesia induction. Using a 22-gauge, 50 mm needle and in the lateral decubitus position, 20 ml of 0.25% Bupivacaine will be injected at the mid-axillary line at the level of the fifth rib, between the serratus anterior muscle and the intercostal muscles on the operative side. This procedure will be performed under sterile conditions with close monitoring for any signs of systemic local anesthetic toxicity prior to the surgical incision. It is noteworthy that the anesthesia induction, maintenance, and all perioperative care will be conducted identically and according to a standardized protocol in both groups. Control Group (Continuous Infusion of Ketodex - ICK):Participants in the ICK group will receive a continuous intravenous infusion of ketamine and Dexmedetomidine immediately after anesthesia induction. Ketamine will be infused at a rate of 5 to 7.5 mcg/kg/min, and Dexmedetomidine at 0.3 to 1 mcg/kg/hour through a single intravenous line under the supervision of an anesthesiology specialist. It is important to note that anesthesia induction, maintenance, and all perioperative care will be conducted identically and according to a standardized protocol in both groups. Nausea and Vomiting. Timepoint: Immediately after surgery, 2, 4, 8, 12, and 24 hours post-op. Method of measurement: PONV score (presence/absence). Arterial Oxygen Saturation (O2 Sat). Timepoint: Upon arrival to OR, then every 15 minutes until end of surgery and in recovery. Method of measurement: Based on the patient's medical record. Pain. Timepoint: Immediately after surgery, 1, 6, 12, and 24 hours post-op. Method of measurement: VAS scale (pain score). Patient Satisfaction with Pain Management. Timepoint: Postoperative period. Method of measurement: Likert scale. Prescribed Morphine Dose. Timepoint: First 24 hours post-op. Method of measurement: Total morphine dose (mg). Shiraz University of Medical Sciences Approved 2025-05-07 Ethics Committee of Shiraz Medical School 3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd. Shiraz Fars Iran (Islamic Republic of)