To compare pain relief after blocking nerves of legs by 2 types of nerve block

Recruiting

• Conditions: Unspecified fracture of lower leg, (2) ICD-10 Condition: O||Medical and Surgical,

• Registration Number: CTRI/2023/04/051720
• Lead Sponsor: Teerthanker Mahaveer Medical College & Research Centre Moradabad Uttar Pradesh

Brief Summary

After approval from institutional ethical committee, patients will be identified undergoing below knee

orthopedic trauma surgeries and participant will be recruited as per inclusion and exclusion criteria.



Randomization will be done using chit & box method & two groups both including 35 patients will be

created (Group-T & Group-S)



1. Group T- Central Neuraxial Block with hyperbaric bupivacaine 0.5% (15 mg).



2. Group S- S.O.F.T Block guided by Ultrasound .

To block the Femoral nerve, 15mL of bupivacaine 0.25% will be injected.

To block the obturator nerve, 10mL of bupivacaine 0.25% will be injected .

To block the sciatic nerve, 20mL of bupivacaine 0.25% will be injected .

Patients will be preloaded with RL solution at the rate of 10 ml/kg within 15 to 20 mins before

surgery.

After successfully performing the block in both the groups, Hemodynamics (HR, RR, SBP, DBP,

MAP, SP02) vitals will be monitored every 2 mins up to 15mins and thereafter every 5 mins until the

completion of surgery.

Post OP vitals will be monitored at 1, 2, 6, 12, 24, 48 hrs. Sensory block will be tested every 2

minutes interval till the establishment of the block and every 5 mins during the surgery.

In the recovery room , testing has to be conducted every 10 min until the point of two segment

regression of block. Duration of analgesia will be assessed from the onset of sensory block to first

request for rescue analgesia (Visual analog score >4). Pain will be assessed at 1, 3, 6, 12, 18, 24

hrs.

Motor block will be assessed using a modified Bromage scale at every 2 mins till the achievement

of Bromage score 3

Motor block will be assessed and graded at the end of surgery and then at 15-min intervals using

the modified Bromage scale, until full return of lower extremity motor function (Score-0) will be

noted and the patients will be given 15mg/kg Paracetamol for post operative pain, Injection

Tramadol 2 mg/kg IV will be given as rescue analgesia (if VAS >4).

The patients will be observed for first 24 hours for nausea, vomiting, rash, pruritis, seizures and

other complications.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-28
• Last Update Posted: 2023-09-05

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Informed consent .
• ASA physical status I-II Body mass index 18.5-24.9 kg/m2.

Exclusion Criteria

• Patients undergoing bilateral surgery.
• Contraindications to regional anesthesia.
• Patients with unstable vital signs and patients with head or chest trauma.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1 Visual Analogue Score	VAS Score 0,15, 30 minutes | 1, 3, 6, 12, 18 hours | Hemodynamics monitored 2, 4, 6, 8, 10, 12, 15, | 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, | 85, 90 minutes, till completion of surgery. | Sensory characteristics every 2 minutes interval | till the establishment of the block and every 5 | mins till surgery. | Motor characteristics at every 2 mins till the | achievement of Bromage score 3 | ,then at the end of surgery and then at 15-min | intervals till( Bromage Score-0)
2 Hemodynamics	VAS Score 0,15, 30 minutes | 1, 3, 6, 12, 18 hours | Hemodynamics monitored 2, 4, 6, 8, 10, 12, 15, | 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, | 85, 90 minutes, till completion of surgery. | Sensory characteristics every 2 minutes interval | till the establishment of the block and every 5 | mins till surgery. | Motor characteristics at every 2 mins till the | achievement of Bromage score 3 | ,then at the end of surgery and then at 15-min | intervals till( Bromage Score-0)
4 Motor characteristics	VAS Score 0,15, 30 minutes | 1, 3, 6, 12, 18 hours | Hemodynamics monitored 2, 4, 6, 8, 10, 12, 15, | 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, | 85, 90 minutes, till completion of surgery. | Sensory characteristics every 2 minutes interval | till the establishment of the block and every 5 | mins till surgery. | Motor characteristics at every 2 mins till the | achievement of Bromage score 3 | ,then at the end of surgery and then at 15-min | intervals till( Bromage Score-0)
3 Sensory characteristics	VAS Score 0,15, 30 minutes | 1, 3, 6, 12, 18 hours | Hemodynamics monitored 2, 4, 6, 8, 10, 12, 15, | 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, | 85, 90 minutes, till completion of surgery. | Sensory characteristics every 2 minutes interval | till the establishment of the block and every 5 | mins till surgery. | Motor characteristics at every 2 mins till the | achievement of Bromage score 3 | ,then at the end of surgery and then at 15-min | intervals till( Bromage Score-0)

Secondary Outcome Measures

Name	Time	Method
Nausea, vomiting , rash , pruritis , seizures and	other complications.

Trial Locations

Locations (1)

Teerthanker Mahaveer Medical College & Research Centre; 🇮🇳 Moradabad, UTTAR PRADESH, India

Teerthanker Mahaveer Medical College & Research Centre

🇮🇳Moradabad, UTTAR PRADESH, India

Dr Karanbir Singh

Principal investigator

7000486410

karankataria36@gmail.com