| CTRI Number |
CTRI/2016/08/007201 [Registered on: 17/08/2016] Trial Registered Prospectively |
| Last Modified On: |
17/08/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
study of addition of tramadol(analgesic) to ropivacaine(local anaesthetic) for wound infiltration in spine
surgeries on postoperative pain relief
|
|
Scientific Title of Study
|
A comparative study of addition of two different doses of tramadol to ropivacaine for wound infiltration in spine
surgeries on postoperative analgesia
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aparna |
| Designation |
Post graduate resident |
| Affiliation |
SVIMS |
| Address |
Department of Anaesthesiology and critical care
SVIMS
Tirupati
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9490713247 |
| Fax |
|
| Email |
appu1021@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aloka Samantaray and Dr B Aparna |
| Designation |
Additional Professor and PG student |
| Affiliation |
Sri Venkateswara institute of Medical Sciences |
| Address |
Department of Anaesthesiology and critical care
SVIMS
Tirupati 517507
Department of Anaesthesiology and critical care
SVIMS
Tirupati 517507
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9493547653 |
| Fax |
|
| Email |
aloksvims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aloka Samantaray |
| Designation |
Additional Professor |
| Affiliation |
|
| Address |
Department of Anaesthesiology and critical care
SVIMS
Tirupati
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
|
| Fax |
|
| Email |
aloksvims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateswara Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Department of Anaesthesiology and Critical care
Sri Venkateswara Institute of Medical Sciences
Tirupati. 517507
|
| Type of Sponsor |
Government 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 Aloka Samantaray |
Sri Venkateswara Institute of Medical Sciences |
Department of Anaesthesiology and Critical care.
Tirupati 517507
Chittoor
ANDHRA PRADESH |
9493547653
aloksvims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
• All patients belonging to American society of Anesthesiologists physical status grade I and II
• Age between 18 to 60 years.
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group 1(RN) |
Wound infiltration with 17 ml of ropivacaine 0.75%20, 21 + normal saline. |
| Intervention |
Group 2(RT1) |
Wound infiltration with 17 ml of ropivacaine 0.75% + tramadol 1 mg/kg. |
| Intervention |
Group 3(RT2) |
Wound infiltration with 17 ml of ropivacaine 0.75 % + tramadol 2 mg/kg. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)All patients belonging to American society of Anesthesiologists physical status grade I and II
2)Age between 18 to 60 years.
|
|
| ExclusionCriteria |
| Details |
1)Allergy to any of study drugs.
2)Patients on treatment with chronic opioids or study drugs.
3)Who have cardiovascular, pulmonary, renal, neurological and metabolic diseases.
4)Inability to comprehend numerical rating scale.
5)Who undergo cervical spine surgeries.
6)Patients unwilling to participate in the study.
7)Pregnant and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome variable will be determined as the time to first analgesic administration by recording numerical rating scale every hour postoperatively after infiltration of the study drug. |
Time frame 24 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any adverse effects observed with ropivacaine and tramadol will be determined as secondary outcome |
Time frame 24 hours after surgery |
|
|
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)
|
19/09/2016 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Wound infiltration by local anaesthetics has become increasingly
common for postoperative analgesia owing to its simplicity, safety and
effectiveness and its provision of effective postoperative analgesia, particularly
after surgical procedures. Tramadol
Hydrochloride is a synthetic analogue of codeine when added as an adjuvant to
local anaesthetic agents, causes an effect similar to that of clonidine and it
can modify the effects of local anaesthetics by directly or indirectly
effecting sodium channels, thus contributing to more effective analgesia. Combination
of ropivacaine and tramadol for wound infiltration after spine surgeries may
provide superior analgesic effects compared with the sole administration of ropivacaine
through the same route. However the optimum dose of tramadol as an adjuvant has
not been defined conclusively. The present study is aim to assess the analgesic
efficacy of two different doses of tramadol added to ropivacaine for wound
infiltration in spine surgeries. Patients will be randomized to receive their study drugs after the
spinal surgery and before closing the incision line .The study drug as per
group allocation will be injected over the incision line on the paravertebral
muscles, cutaneous and subcutaneous tissue with equal volume on either sides.
This will be followed by reversal of residual neuro-muscular block and after
meeting extubation criteria patient will be extubated and shifted to recovery
room. Post operatively pulse rate , blood pressure, respiratory rate, oxygen
saturation , numerical rating score(NRS), sedation score will be monitored
every hourly till the patient complains of pain or NRS > or equal to 4
.Level of sedation will be assessed by Ramsay sedation score. Time to first analgesic requirement will be the time since wound
infiltration done to the time when the patient complains of pain or NRS > or
equal to 4. At that time patients will be administered additional analgesia
with inj fentanyl 1mcg/kg IV. Postoperatively all patients will be given inj
paracetamol 15mg/kg IV every 6th hourly.
Post operatively patients will be monitored for adverse
cardiovascular and respiratory event, nausea, vomiting and any other side
effects will be noted within 24 hours. |