Comparison of efficacy and safety profile of spinal anaesthesia, peripheral nerve block and monitored anaesthesia care for day care varicose vein surgery: A prospective randomized controlled study

AIMS AND OBJECTIVES

The study aims to compare the efficacy and safety profiles of spinal anesthesia, peripheral nerve block, and monitored anesthesia care in varicose vein surgery. It focuses on surgeon satisfaction using the Likert scale, hemodynamics during the perioperative period, time of ambulation and void, patient satisfaction using the Iowa Satisfaction with Anesthesia Scale, length of hospital stay, and complications during the perioperative period.

MATERIAL AND METHODS

The study will be conducted at King George’s Medical University, Lucknow, with a prospective, randomized controlled design. The study will last 18 months, with 33 participants in each group. The study will include 99 cases scheduled for saphenous varicose vein surgery, aged 18-70, with written informed consent. Exclusion criteria include patient refusal, known allergies to anesthesia components, history of bleeding disorders, drug abuse, high cardiovascular risk, and significant pulmonary disease.

The study will be conducted at King George Medical University, Lucknow, using computer-generated random numbers to ensure a balanced distribution of potential confounding factors. Participants will be randomly divided into three groups: Group A (spinal anesthesia), Group B (peripheral nerve block), and Group C (monitored anesthesia care). Spinal anesthesia will be administered using Hyperbaric Ropivacaine 0.75% 15mg with 0.4 ml fentanyl in the L3-L4 or L4-L5 intervertebral space using a 25 G Quincke’s needle under aseptic conditions. Midazolam will be administered intravenously after 15 minutes of injecting intrathecal local anesthetic drugs. Group B (peripheral nerve block) will be determined by the location of varices. Femoral nerve block will be performed using a linear US transducer, while saphenous nerve block will involve locating femoral vessels in the sub sartorial canal and injecting 12ml of 0.75% Ropivacaine all around the nerve without puncturing the nerve. Sciatic nerve block will be performed by identifying popliteal vessels in the popliteal fossa and injecting 12ml of 0.75% Ropivacaine. Laser ablation will be started approximately five minutes after nerve blocks. Motor block will be assessed by evaluating muscle weakness, and patients will be asked to actively dorsi and plantar flex the foot (after femoral block) or flex-extend the knee (after sciatic block) and flex the hip in frequent cycles until they could walk. A Visual Analogue Pain Scale will be employed for assessment of procedural pain in all cases. In Group C, a loading dose of 1 micgmper kg of dexmedetomidine was administered over 10 minutes, followed by a maintenance infusion beginning at a rate of 0.2-0.7 micgmper kg per hr. Sedation state will be assessed every 5 minutes, and the infusion rate of the drug will be titrated to maintain an OAA/S score of 4 or less throughout the surgery. All patient’s perioperative data, including procedure duration, anesthesia onset time, hemodynamic parameters, postoperative pain scores, intra-operative vital signs, cognitive dysfunction, adverse events, and satisfaction of patients and surgeons using the Likert Scale, will be noted. Continuous monitoring of vital signs during surgery and postoperative periods will take place, and adverse events or complications related to each anesthesia method will be recorded.

The outcome assessment includes surgeons’ and patient satisfaction using the Likert scale, changes in hemodynamic parameters, recovery data, time of possible ambulation, intention to use the same anesthesia, nausea or vomiting, post-operative VAS pain score, and complications such as hypertension, bradycardia, tachycardia, and hypoxia.

Statistical analysis

The data will be analyzed using SPSS and MS Excel, with continuous variables expressed as mean standard deviation. Counting data will be expressed as number and percentages. Intergroup comparisons will be made using unpaired and paired t tests, while the chi square test will compare proportion data between groups. Statistical significance will be determined at P less than 0.05.