| CTRI Number |
CTRI/2023/10/058940 [Registered on: 20/10/2023] Trial Registered Prospectively |
| Last Modified On: |
19/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To assess analgesic efficacy of Dexmedetomidine as an adjuvant to bupivacaine in Ultrasound Guided Femoral Nerve Block in Patients Undergoing Elective Surgery for Fracture Shaft of Femur in department of Anaesthesia, SMS Medical college Jaipur |
|
Scientific Title of Study
|
Randomized control study to assess the analgesic efficacy of Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound Guided Femoral Nerve Block in Patients Undergoing Elective Surgery for Fracture Shaft of Femur in department of Anaesthesia, SMS Medical college Jaipur |
| 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 Mamta Khandelwal |
| Designation |
Senior professor |
| Affiliation |
SMS MEDICAL COLLEGE |
| Address |
Department of Anesthesia, SMS Medical college, Jaipur.
Jaipur
RAJASTHAN
302004
India |
| Phone |
9929338174 |
| Fax |
|
| Email |
drmamtakhandelwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Khandelwal |
| Designation |
Senior professor |
| Affiliation |
SMS MEDICAL COLLEGE |
| Address |
Department of Anesthesia, SMS Medical college, Jaipur.
RAJASTHAN
302004
India |
| Phone |
9929338174 |
| Fax |
|
| Email |
drmamtakhandelwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja |
| Designation |
Junior Resident |
| Affiliation |
SMS MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Anesthesia, SMS Medical college, Jaipur.
Jaipur
RAJASTHAN
302004
India |
| Phone |
8053172487 |
| Fax |
|
| Email |
marodiapuja59@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology SMS Medical College and attached Hospitals, Jaipur |
|
|
Primary Sponsor
|
| Name |
Sawai man singh medical college |
| Address |
Department of Anesthesia,second floor, Dhanwantri OPD block,SMS medical college, Jaipur. |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mamta Khandelwal |
SMS Medical college and Hospitals |
Second floor, Dhanwantri OPD block, SMS Medical college, JAipur Rajasthan
Jaipur
RAJASTHAN |
9929338174
drmamtakhandelwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the Ethics Committee, SMS Medical College and Attached Hospitals |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, (2) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
15ml of 0.25% bupivacaine and 1 ug /kg of dexmedetomidine in 2ml of NS in 45 patients |
patient will receive ultrasound guided femoral nerve block by using 15ml of 0.25% bupivacaine and 1 ug /kg of dexmedetomidine in 2ml of NS.NRS score will be assessed at every 1 min interval up to 20 min until the NRS is 3.This time will be noted. In the postoperative
period, the analgesic efficacy
will be assessed at various
intervals for 24 hours |
| Comparator Agent |
15ml of 0.25% bupivacaine and 2ml NS in 45 patients |
Patients will receive ultrasound
guided Femoral nerve block by using 15ml of 0.25% bupivacaine and 2ml NS.NRS score will be assessed at every 1 min interval up to 20 min until the NRS is 3.This time will be noted. In the postoperative period, the analgesic efficacy will be assessed at various intervals for 24 hours |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient undergoing elective surgery for fracture shaft of femur.
Patients consenting to participate.
Adult patients aged 20-70 Years.
Patients belonging to American Society of Anesthesiologists (ASA) grade I, II and III
|
|
| ExclusionCriteria |
| Details |
Patients with psychiatric illness, anxious, agitated.
Patients with peripheral sensorineural deficit.
Patients allergic to local anesthetics.
Patients with contraindications to regional anaesthesia.
Patients with suspected compartment syndrome in lower limbs.
Patients on analgesia within 8 hours before performing nerve block.
Block failure cases(If NRS score is not < 3 within 20 min of performing peripheral nerve block)
|
|
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Method of Generating Random Sequence
|
Random Number Table |
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Method of Concealment
|
On-site computer system |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
1.To assess & compare the difference in mean time of first rescue analgesia in both groups by using NRS score.
2.To observe change in NRS at one minute interval maximum up to 20 minutes after administration of block until NRS 3 for positioning of patient for spinal anaesthesia in both groups
3.To determine the difference in mean dose of analgesic required for 24 hours in both groups.
|
24 hours post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess quadriceps muscle strength using Oxford muscle strength grading.
2.To determine the change in the hemodynamic parameters (HR,SBP,DBP,MAP & SpO2) in both groups.
3.To observe side effect or complication, if any.
|
24 hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/11/2023 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
After obtaining Institutional Ethics Committee approval and written informed consent, 90 patients fulfilling inclusion criteria and undergoing elective surgery for fracture shaft of femur under spinal anaesthesia will be included. Preoperative visit will be conducted on the previous day of surgery and detailed Pre-anaesthetic checkup (PAC) will be done. In the operation theatre, patient will be identified and received, written and informed consent, PAC, and fasting status will be checked. Routine non-invasive monitors will be attached and vital parameters like pre-operative pulse rate, non-invasive blood pressure, and oxygen saturation will be noted. Peripheral venous access will be established in upper limb with 18G IV cannula and intravenous Ringer Lactate solution will be started. Patient randomization will be performed using opaque sealed envelope method. GROUP A (n=45): Patients will receive ultrasound guided Femoral nerve block with 15 ml of 0.25% bupivacaine and 2ml NS (total volume 17 ml) GROUP B (n=45): Patients will receive ultrasound guided Femoral nerve block with 15 ml of 0.25% bupivacaine and 1ug /kg of dexmedetomidine dilute in NS to make 2 ml (Total volume 17 ml) Depending on the allotted group, under all aseptic precautions, patients will receive the respective block under ultrasound guidance in the Operation Theatre. NRS score will be assessed at every 1 min interval up to 20 min until the NRS is <3. This time will be noted. When NRS will be < 3 under all aseptic precautions subarachnoid block will be given in sitting position in L3-L4 space with 0.5% hyperbaric bupivacaine 12.5 mg +25 microgram of fentanyl using 25G Quincke’s needle. When adequate sensory and motor blockade will be achieved, surgery will be started. Intraoperative parameters such as Heart Rate, SBP, DBP, MAP and SpO2 will be monitored according to proforma. When surgery will be completed patients will be shifted to PACU. Inj. Tramadol 100 mg will be given as rescue analgesic and vitals will be monitored for 24 hours. Side effects, if any, will be noted, and managed accordingly. In postoperative period - NRS score will be assessed at hourly interval for 6 hours then at every 2 hour interval for 12 hours and then 4 hour interval for 24 hours.
- Time for need for first rescue analgesia will be recorded. This time will be calculated from the time of administering the block to request of first rescue analgesia by patient at NRS score >3.
- The mean dose of analgesic required for 24 hours in both groups will be noted.
- Quadriceps muscle strength will be assessed.
- Sedation score and Patient satisfaction will be assessed.
- Haemodynamic parameters will be monitored as per proforma.
- Side effects/complications if any will be recorded.
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