| CTRI Number |
CTRI/2023/06/053790 [Registered on: 13/06/2023] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
An observational study to compare two nerve blocks, pericapsular nerve group block and Suprainguinal fascia iliaca block, for analgesia of positioning pain during spinal anaesthesia in patients with hip fracture. |
|
Scientific Title of Study
|
Pericapsular nerve group block versus Suprainguinal fascia iliaca block for analgesia during positioning for spinal anaesthesia in patients with hip fracture : an observational study. |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sinyo Kashung |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College Kozhikode |
| Address |
Department of Anaesthesiology,
GOVERNMENT MEDICAL COLLEGE, KOZHIKODE
Kozhikode
KERALA
673008
India |
| Phone |
8403974036 |
| Fax |
|
| Email |
mail.kashung@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Biji K.P. |
| Designation |
Professor ( CAP) |
| Affiliation |
Government Medical College Kozhikode |
| Address |
Department of Anaesthesiology
GOVERNMENT MEDICAL COLLEGE, KOZHIKODE
Kozhikode
KERALA
673008
India |
| Phone |
8943162543 |
| Fax |
|
| Email |
drbijikp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sinyo Kashung |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College Kozhikode |
| Address |
Department of Anaesthesiology ,
GOVERNMENT MEDICAL COLLEGE, KOZHIKODE
Kozhikode
KERALA
673008
India |
| Phone |
8403974036 |
| Fax |
|
| Email |
mail.kashung@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sinyo Kashung |
| Address |
Government Medical College Kozhikode,
Kerala
Pin- 673008 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Sinyo Kashung |
Government medical college, Kozhikode |
Orthopaedic Operation theatre, Government Medical College, Kozhikode
Kozhikode
KERALA |
8403974036
mail.kashung@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Medical College Kozhikode |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S798||Other specified injuries of hip and thigh, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA Status I and II
2. weight 45-70 kg
3. Height 150- 170 cm |
|
| ExclusionCriteria |
| Details |
1. Patient’s refusal to participate
2. Any contraindications to spinal anaesthesia or peripheral nerve block
3. Past history of drug allergy
4. Liver failure
5. Renal insufficiency
6. Known or suspected coagulopathy
7. Pre-existing neurologic or anatomic deficit in the lower extremities
8. Cognitive impairment with difficulties in pain evaluation
9. Severe psychiatric illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the analgesia 30 minutes after the block in terms of numeric rating score at :
1. Rest
2. Passive 15 degree limb elevation
3. Positioning for spinal anaesthesia |
30 minutes after the block. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To measure :
1. Time taken for execution of block
2. Time to first rescue analgesia |
1. Time taken for execution of block I.e. time taken from placement of ultrasound probe to complete deposition of drug.
2. Time to first rescue analgesia I.e. time from injection of drug in the block to the requirement of analgesia for the NRS of more than 3 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/06/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/12/2023 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Spinal anaesthesia is considered as the gold standard for hip surgeries. However severe pain is encountered during positioning of the patients especially for the commonly used hyperbaric spinal. Parenteral opioids, NSAIDS as well as regional nerve blocks like femoral 3 in 1, fascia iliaca blocks etc are being employed to facilitate patient positioning. Good analgesia during positioning reduces the patient’s suffering, decreases incidence of post traumatic stress, and also makes the procedure easy for the Anaesthesiologist.The Pericapsular nerve group block (PENG) and Suprainguinal fascia iliaca block (SIFI-B) are recently introduced blocks for positioning pain. Girón-Arango et al. introduced a new technique,pericapsular nerve group block (PENG), for selective blockade of the articular branches from the femoral, accessory obturator, and obturator nerve. It has demonstrated sufficient analgesic effect and without any quadriceps weakness in patients with hip fracture.The fascia iliaca block has shown good analgesic efficacy for hip fracture patients with the suprainguinal approach showing superior results than the infrainguinal approach, due to better spread of local anaesthetic under the fascia iliaca. These nerve group blocks provides an opportunity for anaesthesiologists to participate in patient’s pain control early on, especially in terms of offering analgesia for effective pain control. The nerve blocks provide superior analgesia with decreased use of opioids and various other benefits. Regional analgesia with neuraxial anesthesia for hip fracture surgery has a multitude of benefits with positive outcomes and will play a major role in pain and perioperative management in the future. Due to the limited literature comparing newer nerve group blocks i.e. PENG and SIFI-B, we decided to conduct the study. |