| CTRI Number |
CTRI/2021/07/034570 [Registered on: 05/07/2021] Trial Registered Prospectively |
| Last Modified On: |
03/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of butorphanol versus dexmeditomidine as adjuvants to levobupivacaine in ultrasound guided costoclavicular block. |
|
Scientific Title of Study
|
COMPARISON OF ANALGESIC EFFICACY OF BUTORPHANOL VERSUS DEXMEDITOMIDINE AS ADJUVANTS TO LEVOBUPIVACAINE IN ULTRASOUND GUIDED COSTOCLAVICULAR BLOCK: A PROSPECTIVE RANDOMIZED DOUBLE BLIND STUDY |
| 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 PAMIDI JAHNAVI |
| Designation |
SECONDARY DNB ANAESTHESIA RESIDENT |
| Affiliation |
SRI SATHYA SAI INSTITUTE OF HIGHER MEDICAL SCIENCES |
| Address |
SRI SATHYA SAI INSTITUTE OF HIGHER MEDICAL SCIENCES,
DEPARTMENT OF ANAESTHESIA,
PRASHANTIGRAM,PUTTAPARTHI, ANDHRA PRADESH
Anantapur
ANDHRA PRADESH
515134
India |
| Phone |
9553493338 |
| Fax |
|
| Email |
pamedijahnavi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAJAN ANAND |
| Designation |
Senior Consultant, Head of the department |
| Affiliation |
SRI SATHYA SAI INSTITUTE OF HIGHER MEDICAL SCIENCES |
| Address |
SRI SATHYA SAI INSTITUTE OF HIGHER MEDICAL SCIENCES,
DEPARTMENT OF ANAESTHESIA,
PRASHANTIGRAM,PUTTAPARTHI, ANDHRA PRADESH
Anantapur
ANDHRA PRADESH
515134
India |
| Phone |
9440699330 |
| Fax |
|
| Email |
rajan.a@sssihms.org.in |
|
Details of Contact Person
Public Query
|
| Name |
DR PAMIDI JAHNAVI |
| Designation |
SECONDARY DNB ANAESTHESIA RESIDENT |
| Affiliation |
SRI SATHYA SAI INSTITUTE OF HIGHER MEDICAL SCIENCES |
| Address |
SRI SATHYA SAI INSTITUTE OF HIGHER MEDICAL SCIENCES,
DEPARTMENT OF ANAESTHESIA,
PRASHANTIGRAM,PUTTAPARTHI, ANDHRA PRADESH
Anantapur
ANDHRA PRADESH
515134
India |
| Phone |
9553493338 |
| Fax |
|
| Email |
pamedijahnavi@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI SATHYA SAI INSTITUTE OF HIGHER MEDICAL SCIENCES |
|
|
Primary Sponsor
|
| Name |
DR PAMIDI JAHNAVI |
| Address |
SRI SATHYA SAI INSTITUTE OF HIGHER MEDICAL SCIENCES
PRASHANTIGRAM, ANDHRA PRADESH
|
| Type of Sponsor |
Other [SRI SATHYA SAI INSTITUTE OF HIGHER MEDICAL SCIENCES ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR RAJAN ANAND |
SRI SATHYA SAI INSTITUTE OF HIGHER MEDICAL SCIENCES
PRASHANTIGRAM, ANDHRA PRADESH
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| PAMIDI JAHNAVI |
SRI SATHYA SAI INSTITUTE OF HIGHER MEDICAL SCIENCES |
DEPARTMENT OF ANAESTHESIOLOGY,
PRASHANTIGRAM,PUTTAPARTHY.
515134
Anantapur
ANDHRA PRADESH |
9553493338
pamedijahnavi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SATHYA SAI INSTITUTE OF HIGHER MEDICAL SCIENCES |
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 |
butorphanol compared to
dexmeditomididne as an adjuvant to levobupivacaine |
single dose butorphnanol 1mg/kg compared to
dexmedetidomidine 1mcg/kg as an adjuvant to levobupivacaine in ultrasound guided costoclavicular block |
| Intervention |
ultrasound guided costoclavicular block |
comparing analgesic efficacy of single dose butorphnanol 1mg/kg and dexmedetidomidine 1mcg/kg as an adjuvatnt to levobupivacaine in ultrasound guided costoclavicular block. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are willing to give consent to participate in the study.
2. Patients undergoing upper limb surgeries below elbow.
3. Patients between age : 18 to 60 years
4. ASA Grade I and Grade II patients
|
|
| ExclusionCriteria |
| Details |
1. Patients with history of bleeding disorders.
2. Patients with local infection at the site of block.
3. Patients with epilepsy or other convulsive disorders.
4. Patients with documented neuromuscular disorders.
5. Patients with known allergy to local anaesthetic drugs.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia |
Duration of analgesia was assessed using VAS score till 24 hrs postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Onset of sensory blockade
2. Duration of sensory blockade
3. Onset of motor blockade
4. Duration of motor blockade
5. Hemodynamic variations in pulse rate, systolic blood pressure, diastolic blood pressure, spO2
6. Ramsay Sedation Score
7. Complications if any (nausea, vomiting, sedation, hypotension, bradycardia, respiratory depression)
|
1. Onset of sensory blockade
2. Duration of sensory blockade
3. Onset of motor blockade
4. Duration of motor blockade
5. Hemodynamic variations in pulse rate, systolic blood pressure, diastolic blood pressure, spO2
6. Ramsay Sedation Score
7. Complications if any (nausea, vomiting, sedation, hypotension, bradycardia, respiratory depression)
|
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
05/07/2021 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a e prospectivrandomized double blind study comparision of analgesic efficacy of butorphanol versus dexmeditomidine as adjuvants to levobupivacaine in ultrasound guided costoclavicular block that will be conducted in sri sathya sai institute of higher medical sciences.
The primary outcome measures will be duration of analgesia who have received two different drugs for at 8months.
The secondary outcome will be
1. Onset of sensory blockade 2. Duration of sensory blockade 3. Onset of motor blockade 4. Duration of motor blockade 5. Hemodynamic variations in pulse rate, systolic blood pressure, diastolic blood pressure, spO2 6. Ramsay Sedation Score 7. Complications if any (nausea, vomiting, sedation, hypotension, bradycardia, respiratory depression)
|