Comparison analgesia of erector spinae plane block under ultrasound guidance and the combination of subfascial and subcutaneous ropivacaine blocks in open kidney donor nephrectomy surgery

Comparing different postoperative analgesia methods after elective open donor nephrectomy

A clinical trial with 3 groups, with parallel groups, double-blinded, randomized, phase 3 on 105 patients.

After the approval of the ethics committee and obtaining the consent of the patients, 105 candidates for open nephrectomy for kidney donation at Modarres Hospital who meet the entry criteria will be included in the study. Patients are assigned to one of the three groups by simple randomization.

Inclusion criteria: Patients aged 18 to 70 years who are volunteer kidney donors and candidates for elective open nephrectomy and are in physical status I or II according to the American Society of Anesthesiologists (ASA) classification. Exclusion criteria: Use of anticoagulants, presence of blood or coagulation disorders, history of sensitivity to local anesthetics, or patient refusal to participate in the study.

At the end of surgery and prior to anesthesia reversal, patients will be randomized into three groups: Group 1 (ESPB): Under ultrasound guidance, an erector spinae plane block (ESPB) will be performed by the anesthesiologist in the flank position, using 20 mL of 0.25% ropivacaine. Group 2 (Surgeon-Administered): Before fascial closure, the surgeon (the same individual for all patients) will administer 10 mL of 0.25% ropivacaine subfascially and 10 mL of 0.25% ropivacaine subcutaneously at the incision site. Group 3 (Control): Patients will receive morphine 0.1 mg/kg for analgesia, without any nerve block.

The first time requiring analgesic; pain intensity; number of times requiring injectable analgesic; amount of opioid consumption

For randomization, a simple randomization method will be used using Random Generator software. First, a set of random numbers will be generated, then eligible patients will receive a random number before anesthesia. Based on the assigned number, patients will be assigned to one of three study groups (numbers 1 to 35 were assigned to Group 1, numbers 36 to 70 to Group 2, and numbers 71 to 105 to Group 3).

Participant information will be recorded and utilized exclusively using a numerical code to ensure that both their identity and the type of intervention remain unknown. Throughout all stages of data collection, outcome assessment, and statistical analysis, the research team members will only be exposed to these codes and will have no knowledge of the intervention type. (Allocation Concealment) Participants will be unaware of which treatment group they are in. Nevertheless, all treatment methods in the study will be explained to each participant at the beginning when obtaining consent, and the apparent procedures will be identical for all groups, as patients will be under anesthesia during the procedure and the blocks do not create any visual difference for observation. (Blinding) The clinical caregiver (surgeon and anesthesiologist) will only be aware of the type of intervention for the duration of its performance and will have no role in data collection or results analysis after the intervention. The individual responsible for data collection and outcome assessment will only have access to each person’s random code and will be unaware of the group allocation and the type of intervention participants received. The statistical analyst will conduct the data analysis with the coded data, without knowledge of the intervention type, to ensure the blinding process is maintained throughout the study.