a randomised controlled study of comparative effect of hyperbaric 0.75% ropivacaine vs hyperbaric 0.75% ropivacaine with fentanyl in day care varicose vein surgery

Day care varicose vein surgery is a critical surgical procedure that requires careful attention to anesthesia protocols to optimize patient comfort and safety. The selection between hyperbaric ropivacaine and its combination with fentanyl should align with the surgical goals and patient preferences, as patients often desire swift recovery and minimal postoperative complications. The comparison of equipotent doses of hyperbaric 0.75percent ropivacaine alone versus its combination with fentanyl stands out as a pivotal area of study. Ropivacaine is a newer amino-amide local anesthetic (LA) agent similar to bupivacaine in chemical structure but 30-40percent less potent. Intrathecal ropivacaine is a safe and effective option for spinal anesthesia due to its sensory-selective block and lower risk of motor blockade. The addition of fentanyl to this local anesthetic introduces the potential for synergistic effects, altering the pharmacodynamics of the anesthesia and potentially influencing recovery parameters. Understanding how these regimens compare is essential for optimizing anesthesia strategies and improving the overall surgical experience for patients undergoing day care varicose vein procedures. The choice between these two regimens requires careful consideration of multiple factors. Equipotent doses play a crucial role, as achieving comparable analgesia with a reduced total drug load may contribute to faster recovery and decreased side effects. Additionally, patient-specific characteristics, such as age, comorbidities, and pain sensitivity, influence the selection of the most suitable anesthesia protocol. The balance between effective pain control and minimizing adverse effects is paramount in the outpatient setting, where patients aim for a swift return to normal activities. This study addresses the gap in existing literature by providing a comprehensive examination of the comparative efficacy and safety of hyperbaric 0.75percent ropivacaine alone versus its combination with fentanyl in day care varicose vein surgery. Through an in-depth analysis of equipotent doses, patient outcomes, and anesthesia-related parameters, this research aims to contribute valuable insights that can inform evidence-based practices and enhance the quality of care in this specific surgical context. Gupta S et al (2024) evaluated the safety, efficacy, hemodynamic stability, and side effects of spinal anesthesia using 0.5percent hyperbaric bupivacaine and 0.75percent hyperbaric ropivacaine in patients undergoing transurethral resection of prostate. The study found that hyperbaric ropivacaine exhibited significantly slower onset times for sensory and motor blockade compared to hyperbaric bupivacaine. Patients in the ropivacaine group demonstrated better hemodynamic stability and experienced less hypotension compared to those who received bupivacaine. Moreover, the sensory and motor block lasted significantly longer in the bupivacaine group. About 0.75percent hyperbaric ropivacaine is a better choice for spinal anesthesia in elderly patients undergoing TURP as compared to 0.5percent hyperbaric bupivacaine.

AIMS AND OBJECTIVES

Aims:

·        To assess and compare the analgesic efficacy of hyperbaric 0.75percent ropivacaine alone and in combination with fentanyl in day care varicose vein surgery.

·        To evaluate recovery parameters, including time to ambulation and discharge, between the two anesthesia regimens.

Objectives:

·        To study the effect, onset, sensory effect, motor effects of both groups of patients

·        To analyze intraoperative parameters, such as sensory and motor blockade.

·        To investigate postoperative pain intensity and time to first analgesic request.

·        To assess the incidence of adverse effects, including nausea, vomiting, and pruritus.

·        To compare patient satisfaction and overall recovery experience with the two anesthesia approaches.

  MATERIAL AND METHODS

Study Settings: The study will be conducted in Department of Anesthesiology, King George’s Medical University, Lucknow.

Study design:  Prospective randomized controlled study

Study duration: 2 years

Sample size:

Total 80 cases included in the study 40 in each group

 Inclusion criteria:

·        Adult patients aged 18-80 years scheduled for day care varicose vein surgery.

·        Patients giving written informed consent will be taken

Exclusion criteria:

·        Patients with contraindications to spinal anesthesia or a history of opioid sensitivity.

·        Patients not giving consent will not be included in the study.

 STUDY PROTOCOL

Ethical clearance and Written and Informed consent will be taken. The study will be done at King George Medical University, Lucknow.   All randomly allocate participants into two groups:

Group A Hyperbaric 0.75percent ropivacaine alone.

Group B  Hyperbaric 0.75percent ropivacaine with fentanyl.

Administer spinal anesthesia according to group allocation. Standardize the technique, including patient positioning, needle gauge, and injection speed. Record the exact dose administered in both groups.

All patients baseline characteristics: age, gender, BMI, and comorbidities. Monitor intraoperative parameters: blood pressure, heart rate, and oxygen saturation. Assess sensory and motor blockade using standardized scales at defined time intervals.  Record intraoperative adverse events or complications.

All patients evaluate postoperative pain using validated pain scales VAS to be measure. Document time to first request for analgesia. Monitor postoperative adverse effects, including nausea, vomiting, and pruritus. Conduct short-term follow-up to assess any delayed complications or adverse events.

Evaluate patient satisfaction with the anesthesia technique.

Statistical analysis

Statistical analysis was performed by the SPSS version 23rd version. Continuous variables were presented as mean SD and categorical variables were presented as absolute numbers and percentage. Normally distributed continuous variables and categorical variables were compared using appropriate statistical test. P value less than 0.05 was taken as significant.