To compare level of sensory loss resulting in absence of pain sensation and blood pressure stability between supine position and ten degree upward table tilt after administration of spinal block in patients undergoing lower limb arthroscopic surgery.

Phase 3

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/11/059920
• Lead Sponsor: Vardhman Mahavir medical college and Safdarjung Hospital

Brief Summary

This study is a prospective, interventional, comparative randomized study To compare the spinal block characteristics and intraoperative haemodynamic parameters in ten degree reverse Trendelenburg position and supine position in patients undergoing lower limb arthroscopic surgery. In supine (S) group, immediately after the administration of drug into the subarachnoid space the patient will be put into supine position with the operating table parallel to the floor. In reverse Trendelenburg (RT) group, immediately after the administration of drug into the subarachnoid space the patient will be put into supine position with the operating table tilted ten degrees upwards with respect to the floor. The level of spinal block will be assessed bilaterally in the midclavicular line using the cold touch method with an alcohol swab every 30 seconds until onset of sensory block. Maximal level of sensory block defined as number of spinal segments blocked above T12 at 20 min after administration of drug into subarachnoid space. Surgical intervention will begin after adequate level of sensory block is achieved for the surgical procedure. Patients will be monitored throughout the surgery and readings of heart rate, systolic, diastolic and mean arterial pressure and oxygen saturation will be noted at time of spinal block, at 2 mins, 5 mins ,10 mins, 20 mins and 30 mins, thereafter every 15 mins till the end of surgery. Any episode of bradycardia or hypotension will be noted and managed accordingly. Intra operative blood loss, requirement of IV fluids

and blood products will be monitored.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-10-20
• Study Start: 2023-11-28

Recruitment & Eligibility

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

Inclusion Criteria

1.Patients aged 18 to 65 years 2.Belonging to American Society of Anesthesiologists (ASA) physical status class I or II 3.Undergoing lower limb surgery of expected duration less than two hours under spinal anaesthesia.

Exclusion Criteria

1.Patients who are pregnant 2.Obese (BMI > 30 kg/m2) 3.Height <165 cms and >180 cms 4.Known spinal anomaly 5.Local infection 6.Coagulopathies 7.On anticoagulant medication 8.Any contraindication to spinal anaesthesia.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the number of spinal segments blocked above T12 dermatomal level after administration of drug into subarachnoid space in patients undergoing lower limb surgery in ten-degree reverse Trendelenburg position and supine position.	To compare the number of spinal segments blocked above T12 dermatomal level at 20 mins after administration of drug into subarachnoid space in patients undergoing lower limb surgery in ten-degree reverse Trendelenburg position and supine position.

Secondary Outcome Measures

Name	Time	Method
1.To compare the incidence of hypotension & vasopressor requirement.	2.To compare the time taken for regression of spinal block till T12 dermatome level.

Trial Locations

Locations (1)

Vardhman Mahavir medical college and Safdarjung Hospital; 🇮🇳 South, DELHI, India

Vardhman Mahavir medical college and Safdarjung Hospital

🇮🇳South, DELHI, India

Dr Sanmay Panda

Principal investigator

8117825960

sanmaypanda1995@gmail.com