| CTRI Number |
CTRI/2024/06/068792 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
12/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
An observational study to evaluate the onset of effect of spinal anesthesia with addition of the drug Buprenorphine in the drug Ropivacaine 0.75% in lower abdominal surgeries and to study the duration of its effect during and after surgery |
|
Scientific Title of Study
|
AN OBSERVATIONAL STUDY TO EVALUATE ONSET OF SENSORY AND MOTOR BLOCKADE AND DURATION OF SENSORY AND MOTOR BLOCKADE WITH HYPERBARIC ROPIVACAINE(0.75%) WITH BUPRENORPHINE AS AN ADJUVANTS FOR LOWER ABDOMINAL SURGERIES UNDER SPINAL ANAESTHESIA |
| 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 Vaibhavi Hajariwala |
| Designation |
Professor |
| Affiliation |
Shree Krishna Hospital, Pramukh Swami Medical College |
| Address |
Department of Anaesthesiology
Shree Krishna Hospital,
Pramukh Swami Medical College
Gokal Nagar
Karamsad, Dist. Anand
Anand GUJARAT 388325 India |
| Phone |
9909977446 |
| Fax |
|
| Email |
vaibhavih@charutarhealth.org |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vaibhavi Hajariwala |
| Designation |
Professor |
| Affiliation |
Shree Krishna Hospital, Pramukh Swami Medical College |
| Address |
Department of Anaesthesiology
Shree Krishna Hospital,
Pramukh Swami Medical College
Gokal Nagar
Karamsad, Dist. Anand
GUJARAT 388325 India |
| Phone |
9909977446 |
| Fax |
|
| Email |
vaibhavih@charutarhealth.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Akshita Patel |
| Designation |
Resident Doctor |
| Affiliation |
Shree Krishna Hospital, Pramukh Swami Medical College |
| Address |
Department of Anaesthesiology
Shree Krishna Hospital,
Pramukh Swami Medical College
Gokal Nagar
Karamsad, Dist. Anand
Anand GUJARAT 388325 India |
| Phone |
8200002140 |
| Fax |
|
| Email |
akshita.ap.patel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Shree Krishna Hospital,
Gokal Nagar, Karamsad,
Dist. Anand, Gujarat, India 388325 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Shree Krishna Hospital,
Pramukh Swami Medical College,
Gokal Nagar,
Karamsad, Dist. Anand |
| Type of Sponsor |
Private medical college |
|
|
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 Akshita Patel |
Shree Krishna Hospital, karamsad |
ROOM NO 112 , Department of Anaesthesiology ,Shree Krishna Hospital,
Pramukh Swami Medical College,
Gokal Nagar,
Karamsad, Dist. Anand Anand GUJARAT |
08200002140
akshita.ap.patel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-2,bhaikaka university , karamsad, anand |
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 |
| Intervention |
Addition of Buprenorphine in Hyperbaric Ropivacaine 0.75% in spinal anesthesia for lower abdominal surgeries |
23 G Quincke’s spinal needle will be inserted. After confirmation of needle tip in the subarachnoid space by free flow of cerebrospinal fluid, spinal anaesthesia will be given with hyperbaric ropivacaine (0.75%) 3 ML with buprenorphine 150mcg in L2-L3/L3-L4 space through a midline/paramedian approach |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with physical status of ASA(American society of Anaesthesiologists) ASA I to ASA III, Patients undergoing above mentioned lower abdominal surgeries
|
|
| ExclusionCriteria |
| Details |
Patients refusal to spinal anaesthesia, Infection at site of spinal needle insertion, Patients having allergy to local anesthetic drug or drug used in the study, Coagulopathy or bleeding disorder, Increased intracranial pressure, Patients having instrumentation at the site of spinal needle insertion
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the sensory and motor onset and duration of sensory and motor blockade of hyperbaric ropivacaine with buprenorphine in lower abdominal surgeries under spinal anaesthesia |
0 minutes, 10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe post operative time of rescue analgesia, time of first micturition and time of mobilisation after hyperbaric Ropivacaine with Buprenorphine in lower abdominal surgeries under spinal anaesthesia |
From the time of completion of surgery till 24 hours |
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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 1 |
|
Date of First Enrollment (India)
|
24/06/2024 |
| 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
|
After
obtaining ethical committee approval and obtaining written and informed
consent, patients of ASA I to ASA
III who are undergoing elective lower abdominal surgeries such as
abdominal hysterectomy, vaginal hysterectomy, open inguinal hernia repair ,open appendisectomy ,TURP etc. under spinal anaesthesia will be recruited to
participate in this observational study.
Pre anesthetic check up will be
done in all patients with detailed history, general and systemic examination
and investigations. After checking the adequate hours of nil by mouth, arrival
to the pre-operative room heart rate, respiratory rate, blood pressure and spo2
will be recorded in all patients, an intravenous line will be checked and
patients will be preloaded with iv fluids half an hour before anaesthesia.
The patients will be placed in
sitting/lateral
position, under all aseptic precautions skin
and subcutaneous tissue will be infiltered with 2ml of 2% lignocaine. 23 G
Quincke’s spinal needle will be inserted. After confirmation of needle tip in
the subarachnoid space by free flow of cerebrospinal fluid, spinal anaesthesia
will be given with hyperbaric ropivacaine
(0.75%) 3 ML with buprenorphine
150mcg in
L2-L3/L3-L4 space through a
midline/paramedian approach. Our goal will to achieve the level of block at T8
level. After injection, patients will be placed in supine position immediately.
Sensory effect will be assessed by pin prick method and motor effect will be
assessed by modified bromage scale (grade 0- no loss of motor power to grade 4-
complete paralysis).
Using a preformed structured
proforma the following parameters will be recorded: onset
of sensory blockade, onset of motor blockade (Bromage scale 1), maximum
dermatomal level of sensory blockade attained and the time to achieve it,
maximum grade of motor blockade attained and the time to achieve it, total
duration of analgesia and the duration of motor blockade (regression to bromage
0). Other parameters such as total duration of surgery, total intraoperative
fluid given, hemodynamic monitoring till the full recovery of sensory and motor
blockade will be noted. Patients will be also monitored for any adverse effects
like bradycardia, hypotension, nausea, vomiting, headache, pruritus, urinary
retention and any hypersensitivity reactions to drug.[4]
In Post anaesthesia care unit, patients will be monitored for 30 minutes
and then transferred to ward. Iv fluid for 6 hours will be given. Post operative pain will be recorded at 6,12
and 24 hours after surgery using visual analogue score |