Comparing two different nerve Blocks for Reducing Pain in Patients with Hip Fracture before Positioning for Subarachnoid Block.

Phase 3

Not yet recruiting

• Conditions: Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: M20-M25||Other joint disorders,

• Registration Number: CTRI/2023/07/054945
• Lead Sponsor: Prachi Ranjan

Brief Summary

This study is a Prospective randomized interventional comparative study with an aim to to compare analgesiaprovided by ultrasound guided pericapsular nerve group block with that of suprainguinalfascia iliaca block  in patients withhip fracture before positioning for subarachnoid block.This study will be done in single centre in india. In this study-1.Pre Procedural pain will beassessed during rest as well as movement of 15° passive elevation of affectedlimb and recorded on numeric pain rating scale (NRS) 0=no pain,10=worstimaginable pain.

2. At 30mins after administeringthe block, pain will be measured by NRS at rest and on passive limb elevation of15°. (Primary objective)

If the patient reports a NRSscore ≥4 during 15° passive elevation of affected limb, intravenousfentanyl 0.5 μg/kg body weight will be given and 15° passive elevation ofaffected limb will be re-attempted after 5 minutes. If still NRS score is ≥4then Inj. fentanyl 0.5 μg/kg body weight will be repeated every 5 minutes up tomaximum of 3 doses.

3. Patient will be made tosit up for positioning for subarachnoid block after NRS score on 15 degreepassive limb elevation is < 4 or after 3 doses of fentanyl have been givenand NRS pain score  will be noted onsitting up the patient for positioning for subarachnoid block.

4. Total amount of supplementalfentanyl if required for decreasing NRS pain score on 15° passive elevation of affectedlimb at 30 minutes after administration of block will be noted.

5. The ease of spinal positioning (EOSP) will be assessed on the scale of 0–3 (0 = unable to position, 1 =patient had abnormal posturing due to pain and required support for positioning,2 = mild discomfort but does not require support for positioning, 3 = optimalcondition where the patient was able to position himself without pain).

6. Quality of patientposition for subarachnoid block as assessed by anaesthesiologist performingsubarachnoid block will be evaluated as

0=Unsatisfactory,1=Satisfactory, 2=Good or 3=Optimal.

Subarachnoid  block will be performed using a median orparamedian approach at the L3-L4 or L4-L5 interspace using spinal needle using3 ml of 0.5% bupivacaine + fentanyl 10 µg.

7. Heart rate, non invasiveblood pressure (systolic ,diastolic, Mean), respiratory rate and SpO2will be recorded ; a) at rest at 5, 10 ,20, 30 minutes after performing theblock procedure, b) on  15 degree passivelimb elevation at 30 minutes after performing the block and c) on positioning patient( in sitting up position ) for subarachnoid block.

Intraoperative monitoring of heart rate,noninvasive blood pressure (systolic, diastolic and mean) and SpO2 will bedone.

8. Complications such ashypotension (a decrease of mean blood pressure >20% from preanaestheticbaseline values), bradycardia (HR <40 beats/min), hypoventilation (breathingrate <8 breaths/min), nausea and vomiting and signs of LA toxicity will benoted and treated. After surgery, all patients will be transferred to postanesthesia care unit, and hemodynamic parameters will be monitored. Allpatients will receive paracetamol 1gm intraveously 8 hourly.

9.Patient satisfaction scorewill be noted after positioning patient in sitting up position for subarachnoidblock:

Score 1- Good (Willdefinitely accept the block again in future if required).

Score 2- Poor (will neveraccept the block again in future if required).

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-06-07
• Study Start: 2023-07-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Study will be conducted in patients in age group of 18 to 80 years belonging to American society of Anaesthesiologist (ASA) physical status I and II scheduled for Hip fracture surgery under Subarachnoid block.

Exclusion Criteria

Patients who can sit comfortably without requirement of analgesia Patients having contraindication for Subarachnoid block Patients with known allergy to local anesthetic drugs Patients with Pre-existing peripheral nerve neuropathies and having fractures in multiple bones Patients receiving chronic analgesic Therapy Patients with infection over injection site.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare Analgesia provided by ultrasound guided pericapsular nerve group block with that of suprainguinal fascia Iliaca block measured by numerical rating scale score on passive limb elevation of 15 degrees at 30 minutes post block in patients with hip fracture before positioning for subarachnoid block.	Before the block & at 30 minutes after the block

Secondary Outcome Measures

Name	Time	Method
Total amount of supplemental fentanyl if required to reduce pain on 15 degrees limb elevation at 30 minutes after administration of block.	NRS score on positioning patient for subarachnoid block

Trial Locations

Locations (1)

Vardhman Mahavir College And Safdarjung Hospital; 🇮🇳 South, DELHI, India

Vardhman Mahavir College And Safdarjung Hospital

🇮🇳South, DELHI, India

Prachi Ranjan

Principal investigator

7908277893

prachifcb3@gmail.com