“Comparative evaluation of 2 Nerve Blocks (Ultrasound Guided Pericapsular Nerve Group Block with Femoral Nerve Block) for reducing pain associated with positioning for subarachnoid block in patients undergoing hip fracture surgeryâ€.

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2021/08/035976
• Lead Sponsor: Safdarjung hospital and Vardhman Mahavir Medical CollegeNew DelhiIndia

Brief Summary

This prospective randomised study has been designed toevaluate and compare the efficacy of ultrasound guided pericapsular nerve groupblock with that of ultrasound guided femoral nerve block for reducing painassociated with positioning for subarachnoid block in patients undergoingsurgery for hip fracture.

We hypothesise that Ultrasound guided Pericapsular nervegroup block is  more efficacious thanultrasound guided femoral nerve  blockfor reducing pain associated with positioning for subarachnoid block in  patients undergoing surgery for hip fracture.

The study will be conducted on 60 adult patients ( 18-60years of age) of either sex, ASA grades 1 & 2 scheduled  for surgery for  hip fracture undersubarachnoid block.

Patients will be randomly allocated to two groups of 30 eachusing

Computer generated random number table  in two groups P&F. Allocations will beconcealed in sealed numbered opaque envelopes, where F represents groupreceiving femoral nerve block and P represents group receiving PENG block. Oncea patient will consent to enter a trial , an envelope will be opened and thepatient will then be offered the allocated group.

**Group P(N=30) :** Patients will  receiveultrasound guided pericapsular nerve group block with 20 ml of 0.5% ropivacaine.

**Group F(N=30):** Patients  will receiveultrasound guided femoral nerve block with 20 ml of 0.5% ropivacaine . All thepatients will undergo detailed pre anaesthetic checkup and relevantinvestigations.

Patients will be examined one day prior to surgery andsubjected to complete physical as well as systemic examination . All thepatients will be made to fast overnight. The purpose of the

study, advantages and side effects of both the techniques ofthe study will be explained to patients and informed written consent will beobtained.

Preoperatively the patients will be familiarized with visualanalog scale (VAS) pain score and its use in pain assessment.

Upon arrival in the room for block performance, standardmonitoring including heart rate (HR), noninvasive blood pressure (NIBP),electrocardiography (ECG) and pulse oximetry (SpO2) will be established.Intravenous line will be secured with 18 G venous cannula. Ringer lactate  infusion will be started and a nasal cannulawill provide oxygen  (3L/min). Nosedative or analgesic medications will be administered.

Equipment and drugs required for providing generalanaesthesia ,emergency resuscitation, and ultrasound guided nerve blocks willbe kept ready.

Visual Analog Scale (VAS) score will be assessed and notedusing a standard 10 cm VAS with 0 corresponding to no pain and 10 designatingthe worst possible pain before the block at rest and at dynamic hip movement ofaffected limb (straight leg raise of 15degrees above table) .20

Patients will be administered either of the blocks accordingto group allocation.

Heart rate, non invasive blood pressure (systolic ,diastolic,mean), respiratory rate and SpO2 will be recorded at 5,10 and 20 , 30 minutesafter performing the block procedure and at positioning for subarachnoid block andmonitored continuously while performing the block and during perioperativeperiod.

**Procedure:For ultrasound guided Pericapsular nerve group block**

The regional block will be performed with the patient in thesupine position. Using strict aseptic precautions a curvilinear low-frequencyultrasound probe (2-5 MHz, M Turbo, SonoSite Inc., USA) will be initially placedin the transverse plane over the anterior inferior iliac spine and then alignedwith the pubic ramus by rotating the probe counterclockwise approximately 45degrees. In this view the iliopubic eminence, the iliopsoas muscle and tendon,the femoral artery and pectineus muscle will be observed. A skin wheal of localanaesthetic will be made 1 cm away from the lateral edge of the ultrasoundprobe. A 22-gauge, 100-mm long echogenic needle will be inserted from lateralto medial in an in-plane approach to place the tip in the musculofascial planebetween the psoas tendon anteriorly and the pubic ramus posteriorly. Followingnegative aspiration, the local anaesthetic solution (20 ml of 0.5% ropivcaine)will be injected in 5-mL increments while observing for adequate fluid spreadin this plane.13

**Procedure:For ultrasound guided femoral nerve group block**

Femoral block will be performed  with the patient in the supine position.Using strict aseptic precautions a linear transverse high frequency probe(8-18MHz M Turbo Sonosite)  will be positionedover the femoral crease to identify the femoral artery and nerve. If the nerveis not immediately apparent lateral to the artery,  the transducer will be tilted proximally ordistally to highlight the nerve from the iliacus muscle and the moresuperficial adipose tissue. In doing so, an effort will be made to identify theiliacus muscle and its fascia, as well as the fascia lata. Once the femoralnerve is identified, a skin wheal of local anaesthetic will be made 1 cm away fromthe lateral edge of the transducer. The 80mm long , 22 gauge echogenic  needle will be inserted in-plane in a lateral to medial orientation and advanced towardthe femoral nerve after piercing fascia lata and layer of fascia iliaca. Afternegative aspiration 20 ml of 0.5% ropivacaine will be injected and spread ofthe drug will be noted by displacement of the femoral nerve.19

After 20 min patient will be moved to operating room. Patientwill be made to sit up for positioning for subarachnoid block 30 minutes after administrationof the analgesic  block.

Subarachnoid block will be performed using a median orparamedian approach at the L3-L4 or L4-L5 interspace using spinal needle.

PENG block and femoral nerve blocks will be given by an anaesthesiologistwho would have performed both the blocks 10 times before starting the studycases. Observation for various parameters will be done by otheranaesthesiologists blinded to the type of block given.

If the patient reports a VAS score ≥4 during positioning,procedure will be stopped,intravenous fentanyl 0.5 μg/kg will be given and  positioning will be re-attempted after 5minutes. reduction of VAS to less than 4 by giving intravenous  0.5 μg/kg of inj. fentanyl every 5 minutes repeatedup to maximum of 3 doses..

 Primary objective is to compare the analgesia providedby  ultrasound guided pericapsular nervegroup block with that of ultrasound guided femoral nerve block on positioningfor subarachnoid block in patients undergoing surgery for hip fracture usingvisual analog scale (VAS)  score forpain.

Secondary objective: Quality of patient’s position forsubarachnoid block , Total amount of fentanyl required during positioning forsubarachnoid block, Time taken for performing subarachnoid block, Patient’s satisfactionwith the  nerve block .

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-09
• Last Update Posted: 2021-08-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.Patients with American Society of Anaesthesiologist (ASA) physical status grade I & II scheduled for surgery for hip fracture under subarachnoid block.

Exclusion Criteria

• 1.Patients who can sit comfortably 2.
• Having contraindication for subarachnoid bock 3.Known allergy to local anesthetic drugs 4.Pre-existing peripheral nerve neuropathies 5.Having multiple fractures 6.Receiving chronic analgesic therapy 7.With infection over injection site 8.
• Hypotension 9.
• Impaired cognition.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) score is a standard 10 cm line with 0 corresponding to no pain and 10 designating the worst possible pain.	1.Before the administration of Peripheral nerve block at rest and dynamic hip movement. | 2.After the administration of Peripheral nerve block at rest | 3.After the administration of Peripheral nerve block at 5 min | 4.After the administration of Peripheral nerve block at 10 min. | 5.After the administration of Peripheral nerve block at 20 min. | 6.After the administration of Peripheral nerve block at 30 min. | 7.While positioning for subarachnoid block.
VAS will be assessed and noted before the administration of block at rest and at dynamic hip movement of affected limb by straight leg raise of 15 degrees above table . VAS after the administration of the block will be assessed at rest at 5, 10, 20 and 30 minutes and then during positioning for subarachnoid block 30 minutes after the block.	1.Before the administration of Peripheral nerve block at rest and dynamic hip movement. | 2.After the administration of Peripheral nerve block at rest | 3.After the administration of Peripheral nerve block at 5 min | 4.After the administration of Peripheral nerve block at 10 min. | 5.After the administration of Peripheral nerve block at 20 min. | 6.After the administration of Peripheral nerve block at 30 min. | 7.While positioning for subarachnoid block.

Secondary Outcome Measures

Name	Time	Method
Total amount of fentanyl required for decreasing VAS to less than 4 during positioning for subarachnoid block will be noted.	While positioning for subarachnoid block.
Quality of patient position for subarachnoid block as assessed by anesthesiologist performing subarachnoid block will be evaluated.	While performing subarachnoid block.
Time taken for performing subarachnoid block measured from the start of positioning maneuvers to the spinal needle removal.	While performing subarachnoid block.
Heart rate, non invasive blood pressure( systolic ,diastolic, Mean), respiratory rate and SpO2 will be recorded at 5,10 and 20 , 30 minutes after performing the block procedure and at positioning for subarachnoid block.	Before block;5,10,20,30 min after block; While positioning for subarachnoid block
Patient satisfaction score will be noted after 24 hours of performance of analgesic block	24 hours after the block.
Complications such as hypotension (a decrease of mean blood pressure 20% from preanaesthetic baseline values), bradycardia (HR 50 beats/min), hypoventilation (breathing rate 8 breaths/min), nausea and vomiting and signs of LA toxicity will be noted and treated.After surgery, all patients will be transferred to post anesthesia care unit, and hemodynamics will be monitored.	Post surgery observation.

Trial Locations

Locations (1)

Safdarjung Hospital; 🇮🇳 Delhi, DELHI, India

Safdarjung Hospital

🇮🇳Delhi, DELHI, India

Animesh Tah

Principal investigator

7982575566

animeshtah1995@gmail.com