| CTRI Number |
CTRI/2025/04/084212 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
06/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Spinal anesthesia and nerve blocks: A comparison of their effects on post-surgery recovery after below-knee surgery |
|
Scientific Title of Study
|
Comparative study of Spinal anaesthesia and Peripheral nerve block on Post
operative quality of recovery in below knee surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhishek R |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Anaesthesiology office, 1st floor, Sir Sunderlal hospital, Banaras Hindu University, Pandit Madan Mohan Malaviya Road, Kabir colony, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7760060684 |
| Fax |
|
| Email |
abhiavi2024@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumita Kumari |
| Designation |
Assistant Professsor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Anaesthesiology office, 1st floor, Sir Sunderlal hospital, Banaras Hindu University, Pandit Madan Mohan Malaviya Road, Kabir colony, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8765514029 |
| Fax |
|
| Email |
drsumita.1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumita Kumari |
| Designation |
Assistant Professsor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Anaesthesiology office, 1st floor, Sir Sunderlal hospital, Banaras Hindu University, Pandit Madan Mohan Malaviya Road, Kabir colony, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8765514029 |
| Fax |
|
| Email |
drsumita.1@gmail.com |
|
|
Source of Monetary or Material Support
|
| By Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India 221005 |
|
|
Primary Sponsor
|
| Name |
Banaras Hindu University Varanasi |
| Address |
Department of Anaesthesiology office, 1st floor, Sir Sunderlal hospital, Banaras Hindu University, Pandit Madan Mohan Malaviya Road, Kabir colony, Varanasi, Uttar Pradesh, India 221005 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhishek R |
Institute of Medical Sciences, Banaras Hindu University |
Department of Anaesthesiology office, 1st floor, Sir Sunderlal hospital, Banaras Hindu University, Pandit Madan Mohan Malaviya Road, Kabir colony, Varanasi
Varanasi
UTTAR PRADESH |
7760060684
abhiavi2024@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Of Medical Sciences_ethics_committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Peripheral nerve block |
Comparative group includes two peripheral nerve blocks for below knee surgeries which are popliteal sciatic nerve block and saphenous nerve block. For Popliteal Sciatic nerve block, the patient will be positioned in lateral decubitus position with the operative side upward. A peripheral nerve stimulator will be used to confirm the nerve location. The popliteal fossa will be visualised to identify the tibial and popliteal nerves with the aid of a curvilinear, low frequency ultrasound probe. Using a 100mm Stimuplex A needle, 22ml mixture containing of 20ml Inj. Ropivacaine 0.5% with 2ml Injection Dexamethasone 4mg will be deposited as necessary to obtain circumferential spread around both tibial and common peroneal nerve. For saphenous nerve, block the patient will be in supine position. By similar technique, in supine position, under ultrasound guidance saphenous nerve will be located and 11ml mixture consisting 10ml Injection Ropivacaine 0.2% with 1ml Injection Dexamethasone 4mg will be deposited at the junction between middle and distal third of thigh, lateral to femoral artery and deep to sartorius muscle. Duration of surgery will be 2 hours. |
| Intervention |
Spinal Anaesthesia |
Spinal anaesthesia will be achieved by injecting 2.5ml or 12.5mg of Injection Bupivacaine heavy 0.5% with addition of 0.5ml or 25mcg of Injection Fentanyl under all aseptic precautions at the lumbar vertebral L4-L5 level through a 25G Quincke spinal needle in sitting position and median approach. Duration of surgery will be 2 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
To study and compare peri-operative hemodynamic parameters.
|
To record Heart rate, Systolic and Diastolic Blood pressure, Oxygen saturation, Visual Analog scale for pain at 1hour, 2hour, 4hour, 6hour, 10hour, 16hour, 24hour, 36hour, 48hour, 72hour |
| To study and compare time of onset of Sensory and Motor blockade |
Record time of onset of sensory and motor blockade post procedure.
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will be conducted in Department of anaesthesiology, Institute of
Medical Sciences, Banaras Hindu University, Varanasi. After approval from
hospital research and ethical committee, a Prospective Randomized study will
be conducted on patients coming to Institute of Medical Sciences, BHU, Varanasi.
The cases will be selected according to inclusion and exclusion criteria. A total of
70 patients will be randomly divided into two groups by computer generated
sampling. To ensure equal samples in each group, the block randomisation
method will be used. Group ‘S’ for spinal anaesthesia and Group ‘P’ for
peripheral nerve blocks.
The day before surgery, all patients will undergo thorough examination and
introduced to Visual Analogue Scale (VAS) and QoR-40 questionnaire. All
patients 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 an
18G intravenous cannula will be secured and all ASA standard monitors will be
attached. All patients will receive Inj. Ondansetron 4mg IV 5mins before
procedure.
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 aseptic
precautions at the lumbar L4-L5 level through a 25G Quincke spinal needle in
sitting position and median approach.
In Group P, for the Sciatic nerve block, the patient will be positioned in lateral
decubitus position with the operative side upward. A peripheral nerve
stimulator will be used to confirm the nerve location. The popliteal fossa will be
visualised to identify the tibial and popliteal nerves with the aid of a curvilinear,
low frequency ultrasound probe. Using a ‘100mm Stimuplex A’ needle, 22ml
mixture containing of 20ml Inj. Ropivacaine 0.5% + 2ml Inj.
Dexamethasone(4mg) will be deposited as necessary to obtain circumferential
spread around both tibial and common peroneal nerve. For saphenous nerve
block the patient will be in supine position. By similar technique, in supine
position, under ultrasound guidance saphenous nerve will be located and 11ml
mixture consisting of 10ml Inj. Ropivacaine 0.2% + 1ml Inj. Dexamethasone(4mg)
will be deposited at the junction between middle and distal third of thigh, lateral
to femoral artery and deep to sartorius muscle.
All the nerve blocks will be performed by the investigator. The investigator will
be trained in the technique of anaesthesia and the techniques will be validated
by the guide before study. The onset of block will be evaluated in the operating
theatre for each from 1 min to 30 mins. If a complete block is not achieved in
either Group S/Group P, it will be considered a failed block (drop out) and the
subject will be excluded from the study to avoid bias, but the patient will be
operated on, either by General anaesthesia or Spinal anaesthesia.
During the operative procedure, all patients will receive 4L/min oxygen via face
mask and will be sedated with 1mg Midazolam. For a hypotensive episode,
defined as a decrease in mean arterial pressure of >20% of basal value, the
patient will receive 200ml IV fluid bolus, if not resolved, the patient will receive
Inj. Mephentermine 5mg IV. For an episode of bradycardia defined, defined as a
decrease in heart rate of >20% of base value, the patient will receive Inj. Atropine
10-20mcg/kg.
Vitals will be monitored every 15mins during surgery(<2hrs). After the end of
surgery, the patient will be shifted to Post Anaesthesia Care Unit (PACU), where
patient’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 and
vomiting and other complications, if any will be recorded over 72hrs by the
investigator.
The quality of post operative functional recovery will be assessed using the QoR40 questionnaire, which assess five dimensions of recovery: Physical comfort (12
items), Emotional state (9 items), Physical independence (5 items), Psychological
support (7 items) and 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, POD-1, POD-3 between 8-10pm. The primary outcome of
interest will be POD-1. |