Spinal anesthesia and nerve blocks: A comparison of their effects on post-surgery recovery after below-knee surgery

Phase 3

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2025/04/084212
• Lead Sponsor: Banaras Hindu University Varanasi

Brief Summary

This study will be conducted in Department of anaesthesiology, Institute ofMedical Sciences, Banaras Hindu University, Varanasi. After approval fromhospital research and ethical committee, a Prospective Randomized study willbe conducted on patients coming to Institute of Medical Sciences, BHU, Varanasi.The cases will be selected according to inclusion and exclusion criteria. A total of70 patients will be randomly divided into two groups by computer generatedsampling. To ensure equal samples in each group, the block randomisationmethod will be used. Group ‘S’ for spinal anaesthesia and Group ‘P’ forperipheral nerve blocks.The day before surgery, all patients will undergo thorough examination andintroduced to Visual Analogue Scale (VAS) and QoR-40 questionnaire. Allpatients will receive the following premedication Tab. Ranitidine 150mg per oral,Tab. Metoclopramide 10mg per oral, Tab. Alprazolam 0.25mg per oral. After an 8hr fast, the patients will be taken into the operation theatre, where an18G intravenous cannula will be secured and all ASA standard monitors will beattached. All patients will receive Inj. Ondansetron 4mg IV 5mins beforeprocedure.In Group S, Spinal anaesthesia will be achieved by injecting 2.5ml(12.5mg) of Inj.Bupivacaine heavy 0.5% + 0.5ml(25mcg) Inj. Fentanyl under all asepticprecautions at the lumbar L4-L5 level through a 25G Quincke spinal needle insitting position and median approach.In Group P, for the Sciatic nerve block, the patient will be positioned in lateraldecubitus position with the operative side upward. A peripheral nervestimulator will be used to confirm the nerve location. The popliteal fossa will bevisualised to identify the tibial and popliteal nerves with the aid of a curvilinear,low frequency ultrasound probe. Using a ‘100mm Stimuplex A’ needle, 22mlmixture containing of 20ml Inj. Ropivacaine 0.5% + 2ml Inj.Dexamethasone(4mg) will be deposited as necessary to obtain circumferentialspread around both tibial and common peroneal nerve. For saphenous nerveblock the patient will be in supine position. By similar technique, in supineposition, under ultrasound guidance saphenous nerve will be located and 11mlmixture consisting of 10ml Inj. Ropivacaine 0.2% + 1ml Inj. Dexamethasone(4mg)will be deposited at the junction between middle and distal third of thigh, lateralto femoral artery and deep to sartorius muscle.All the nerve blocks will be performed by the investigator. The investigator willbe trained in the technique of anaesthesia and the techniques will be validatedby the guide before study. The onset of block will be evaluated in the operatingtheatre for each from 1 min to 30 mins. If a complete block is not achieved ineither Group S/Group P, it will be considered a failed block (drop out) and thesubject will be excluded from the study to avoid bias, but the patient will beoperated on, either by General anaesthesia or Spinal anaesthesia.During the operative procedure, all patients will receive 4L/min oxygen via facemask and will be sedated with 1mg Midazolam. For a hypotensive episode,defined as a decrease in mean arterial pressure of >20% of basal value, thepatient will receive 200ml IV fluid bolus, if not resolved, the patient will receiveInj. Mephentermine 5mg IV. For an episode of bradycardia defined, defined as adecrease in heart rate of >20% of base value, the patient will receive Inj. Atropine10-20mcg/kg.Vitals will be monitored every 15mins during surgery(<2hrs). After the end ofsurgery, the patient will be shifted to Post Anaesthesia Care Unit (PACU), wherepatient’s hemodynamic parameters, pain status will be monitored. When VAS>/= 4 rescue analgesia will be provided in the form of intermittent boluses of Inj.Diclofenac 1-1.5mg/kg IV. For intolerable nausea and vomiting, Inj.Metoclopramide 10mg IV will be given. Time to first rescue analgesic request,supplemental rescue analgesic requirements, post operative nausea andvomiting and other complications, if any will be recorded over 72hrs by theinvestigator.The quality of post operative functional recovery will be assessed using the QoR40 questionnaire, which assess five dimensions of recovery: Physical comfort (12items), Emotional state (9 items), Physical independence (5 items), Psychologicalsupport (7 items) and Pain (7 items). Each item will be rated on a 5 Point Likertscale: none of the time, some of the time, usually, most of the time and all of thetime. The total score on the QoR-40 ranges from 40 (poorest quality of recovery)to 200 (best quality of recovery). The QoR-40 will be studied three times: the daybefore surgery, POD-1, POD-3 between 8-10pm. The primary outcome ofinterest will be POD-1.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-05
• Last Update Posted: 2025-06-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 1.Patients undergoing below knee surgery 2.American society of Anaesthesiologists grade 1 and 2 3.
• Mini Mental State Examination score more than 24 4.
• Duration of surgery less than 2 hours.

Exclusion Criteria

1.Patients allergic to local anaesthetic agents 2.Bleeding disorders 3.Localised infections 4.Neurological disease 5.Anatomical abnormalities of spinal column 6.Respiratory/cardiac disease 7.Body mass index more than 32kg/m2 8.Patient not giving consent 9.Patients with polytrauma, cardiothoracic, CNS injury.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study and compare Spinal Anaesthesia and Peripheral nerve blocks Popliteal Sciatic and Saphenous nerve block on Post operative quality of recovery in below knee surgery	Intraoperatively vitals will be recorded every 15 minutes. Postoperatively, The quality of post operative functional recovery will be assessed using the QoR40 questionnaire, which assess five dimensions of recovery which are 1. Physical comfort (12 items), 2. Emotional state (9 items), 3. Physical independence (5 items), 4. Psychological support (7 items) and 5.Pain (7 items). Each item will be rated on a 5 Point Likert scale: none of the time, some of the time, usually, most of the time and all of the time. The total score on the QoR-40 ranges from 40 (poorest quality of recovery) to 200 (best quality of recovery). The QoR-40 will be studied three times: the day before surgery, Post operative day-1 and 2 between 8-10pm.

Secondary Outcome Measures

Name	Time	Method
To study and compare peri-operative hemodynamic parameters.
To study and compare time of onset of Sensory and Motor blockade	Record time of onset of sensory and motor blockade post procedure.

Trial Locations

Locations (1)

Institute of Medical Sciences, Banaras Hindu University; 🇮🇳 Varanasi, UTTAR PRADESH, India

Institute of Medical Sciences, Banaras Hindu University

🇮🇳Varanasi, UTTAR PRADESH, India

Dr Abhishek R

Principal investigator

7760060684

abhiavi2024@gmail.com