Comparison serratus anterior block versus intraoperative continuous infusion of ketodex in acute pain management of thoracotomy-Randomized clinical trial

Comparison serratus anterior block versus intraoperative continuous infusion of ketodex in acute pain management of thoracotomy-Randomized clinical trial

This is a double-blind, block-randomized clinical trial, phase 2-3, with 50 patients in two parallel groups. Randomization sequence was generated via www.sealedenvelope.com.

This study is conducted at Abu Ali Sina Hospital. Patients are randomly assigned to intervention and control groups after anesthesia induction. The anesthesiologist performing the interventions is aware of the group assignments, whereas the clinical assessor and statistical analyst are blinded.

Inclusion Criteria The major inclusion criteria are adult patients aged 18 years and older who are scheduled for elective thoracotomy and have the ability to provide informed and voluntary consent to participate in the study. Exclusion Criteria The major exclusion criteria include allergy to study medications, coagulation disorders or use of anticoagulants, psychiatric or cognitive disorders affecting the ability to provide informed consent, chronic use of opioids or other analgesics, and a history of previous chest surgery.

Intervention group (SAB): Patients immediately after anesthesia induction receive 20 ml of 0.25% bupivacaine 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. Control group (ICK): Patients receive a continuous intravenous infusion of ketamine at a dose of 5 to 7.5 micrograms per kilogram per minute and Dexmedetomidine at a dose of 0.3 to 1 microgram per kilogram per hour through a single intravenous line under the supervision of an anesthesiologist after anesthesia induction.

Pain

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.

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.