| CTRI Number |
CTRI/2023/03/050377 [Registered on: 06/03/2023] Trial Registered Prospectively |
| Last Modified On: |
03/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
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Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
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Public Title of Study
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To study the action of Dexmedetomidine drug added to Ropivacaine for blocking nerves before below knee surgery
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Scientific Title of Study
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EVALUATION OF THE EFFECT OF DEXMEDETOMIDINE AS ADJUVANT TO ROPIVACAINE IN ULTRASOUND GUIDED POPLITEAL SCIATIC NERVE BLOCK IN BELOW KNEE SURGERY-A ONE YEAR HOSPITAL BASED DOUBLE BLIND RANDOMIZED CLINICAL TRIAL†|
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hridya VN |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Nehru Medical college,Belagavi |
| Address |
Department of Anaesthesiology,Jawaharlal Nehru Medical college,Nehru Nagar,Belagavi-10
ManjimaOralakkottu(H),Kizhakkoth,673572,calicut,Kerala
Belgaum
KARNATAKA
590010
India |
| Phone |
9447988143 |
| Fax |
|
| Email |
hridyavn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVandana A Gogate |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical college,Belagavi |
| Address |
Department of Anaesthesiology,Jawaharlal Nehru Medical college,Nehru Nagar,Belagavi-10
Belgaum
KARNATAKA
590010
India |
| Phone |
9019693125 |
| Fax |
|
| Email |
vandanagogate@gmail.com |
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Details of Contact Person
Public Query
|
| Name |
Hridya VN |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Nehru Medical college,Belagavi |
| Address |
Department of Anaesthesiology,Jawaharlal Nehru Medical college,Nehru Nagar,Belagavi-10
ManjimaOralakkottu(H),Kizhakkoth,673572,calicut,Kerala
Belgaum
KARNATAKA
590010
India |
| Phone |
9447988143 |
| Fax |
|
| Email |
hridyavn@gmail.com |
|
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Source of Monetary or Material Support
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| JawaharlalNehru MedicalCollege,Belagavi-10 |
|
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Primary Sponsor
|
| Name |
Hridya VN |
| Address |
JNMC,Nehru Nagar,Belagavi-10,Karnataka |
| Type of Sponsor |
Other [Self] |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Hridya VN |
JNMC,Belagavi |
2nd Floor,Department of Anaesthesiology,JNMC,Nehru Nagar,Belagavi-10,Karnataka
Belgaum
KARNATAKA |
9447988143
hridyavn@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Instituitional Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Popliteal Sciatic nerve block |
Popliteal Sciatic nerve block is being increasingly used for below knee surgeries.Post operative analgesia produced by commonly used local anaesthetics such as Ropivacaine or Bupivacaine is often limited.
Dexmedetomidine is a newer alpha-2 Agonist which when added to local anaesthetics should improve the quality of intraoperative anaesthesia as well as duration of postoperative analgesia.
Hence this study is being undertaken to determine the effect of addition of Dexmedetomidine to Ropivacaine in Popliteal sciatic nerve block.
After obtaining approval from the ethical committee, written informed consent will be taken from the study participants during Preanaesthetic evaluation.
All patients will be assigned randomly to either of the two groups using a computer generated randomization table.
Group A-will receive 15 mL of 0.75% Ropivacaine+0.5mL(50mcg) Dexmedetomidine.
Group B- will receive 15mL of 0.75% Ropivacaine +0.5mL Normal saline.
A thorough preanaesthetic evaluation is done.All patients will be kept Nil per oral 6 hours before surgery.
On the day of surgery 18/20 G IV cannula will be secured .After taking the patients to the operation theatre,all standard monitors like ECG ,NIBP and pulse oximeter will be attached.Baseline Heart rate,SBP,DBP,MAP and SpO2 will be noted..Oxygen will be supplied by face mask throughout the procedure at 5L/min.
Strict aseptic precautions will be taken.Ultrasound machine will be placed on the opposite side of the limb that has to be blocked.Patient will be laid in prone position.Using a high-frequency linear probe,popliteal fossa will be scanned to identify Tibial Nerve and Common peroneal nerve separately lying superficially and posteriorly to popliteal artery.Then we will move the probe proximally to see these nerves converging to form the Sciatic nerve above the popliteal crease.
At this level, 23 G Quincke’s spinal needle will be advanced using in-plane needling approach.With direct ultrasonographic visualization and after negative aspiration ,the LA mixture will be deposited below and above the Sciatic nerve where the Tibial nerve and Common peroneal nerve unite.
Onset of Nerve blockade will be assessed by pin prick testing.In patients with failure to achieve adequate surgical anaesthesia after 20 minutes of administration of block,will be considered as block failure and will be excluded from the study.
Haemodynamic parameters will be monitored and recorded at regular intervals of 10 minutes.
Duration of Sensory and motor Block will be noted by using Cold swab test and Modified Bromage scale respectively.Postoperatively, Pain will be assessed by using VAS Scale.
|
| Comparator Agent |
Popliteal Sciatic nerve block with adding Dexmedetomidine |
The popliteal sciatic nerve block is a form of regional anesthesia used for surgeries below the knee.
Profound analgesia during both the operative and post-operative time periods and the avoidance of systemic complications are also potential benefits of the popliteal nerve block.It is also beneficial in medically compromised patients.
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA grade I,II and III
2.Age between 18-70years undergoing Below knee surgry |
|
| ExclusionCriteria |
| Details |
1)Patient refusal.
2)ASA grade IV or more
3)History of any Allergy to study drug.
4)Any contraindication for regional anaesthesia
5)Infection at intended site of injection
6)Pregnant patients
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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An Open list of random numbers |
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Blinding/Masking
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Double Blind Double Dummy |
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Primary Outcome
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| Outcome |
TimePoints |
| To evaluate the effect of Dexmedetomidine as adjuvant to Ropivacine in ultrasound guided Popliteal Sciatic nerve block in below knee surgery. |
1st 24 hours post surgery |
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Secondary Outcome
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| Outcome |
TimePoints |
To determine the effect on intraoperative hemodynamic parameters.
To determine the time to 1st dose of analgesic in the postoperative period.
To determine the total analgesic requirement in 1st 24 hours post surgery
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1st 24 hours post surgery
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Target Sample Size
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Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
|
06/03/2023 |
| 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 |
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Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
None yet |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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The popliteal sciatic nerve block is a form of regional anesthesia used for surgeries below the knee. Profound analgesia during both the operative and post-operative time periods and the avoidance of systemic complications are also potential benefits of the popliteal nerve block.It is also beneficial in medically compromised patients.¹ Regional anaesthesia with long-acting local anaesthetics (LAs), such as ropivacaine, is beneficial for effective postoperative pain control, but the duration of sensory block is still not sufficient to avoid the postoperative use of opioids. Perineural catheters and continuous infusion are an effective alternative to prolong the analgesic effects, but they can present challenges related to patient management, catheter displacement and the potential for increased infection risk.So the use of adjuvants, such as adrenaline, clonidine, opioid and steroids, with local anaesthetics for early onset and for prolonging the duration of blocks has been practiced for many years and remains the subject of much interest.² Dexmedetomidine, a highly selective alpha-2 adrenergic receptor agonist that has an alpha-2 to alpha-1 selectivity ratio 7 times greater than that of clonidine, has recently been investigated for its analgesic effects and has the potential to become an alternative to clonidine. Dexmedetomidine seems to exhibit synergism with local anaesthetics, prolonging their duration of action. The clinical evidence for the use of dexmedetomidine as an adjuvant to local anaesthetic for peripheral nerve blocks was limited to few animal and human studies. Many trials of dexmedetomidine as adjuvant to local anaesthetics in Brachial plexus block,TAP block,Femoral block etc have been published,thus prompting a re-examination specifically to assess the role of dexmedetomidine in prolonging the action of Ropivacaine in Popliteal block.³ So in this randomized study,we want to evaluate the effect of Dexmedetomidine in onset and duration of sensory and motor block as adjuvant to Ropivacaine in popliteal sciatic nerve block.Also its effect on hemodynamic parameters and Post operative pain relief will be studied.
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