CTRI Number |
CTRI/2019/02/017736 [Registered on: 20/02/2019] Trial Registered Prospectively |
Last Modified On: |
19/02/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Other |
Public Title of Study
|
Effect of adding dexmedetomidine to local anaesthetic wound infiltration for post surgery pain relief |
Scientific Title of Study
|
The effect of dexmedetomidine as an adjuvant to ropivacaine for wound infiltration in providing postoperative analgesia for open abdominal surgeries. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Sumadhu |
Designation |
PG |
Affiliation |
Sri venkateswara institute of medical sciences |
Address |
Department of anaesthesiology,SVIMS University,Tirupathi
Chittoor ANDHRA PRADESH 517507 India |
Phone |
9177704349 |
Fax |
|
Email |
sumadhu13121991@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Aloka Samantaray |
Designation |
Professor and head of the department |
Affiliation |
Sri venkateswara institute of medical sciences |
Address |
Department of anaesthesiology,SVIMS,Tirupathi
Chittoor ANDHRA PRADESH 517507 India |
Phone |
9493547653 |
Fax |
|
Email |
aloksvims@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Aloka Samantaray |
Designation |
Professor and head of the department |
Affiliation |
Sri venkateswara institute of medical sciences |
Address |
Department of anaesthesiology,SVIMS,Tirupathi
Chittoor ANDHRA PRADESH 517507 India |
Phone |
9493547653 |
Fax |
|
Email |
aloksvims@gmail.com |
|
Source of Monetary or Material Support
|
Sri Venkateswara institute of medical sciences,Alipiri road,Tirupathi,517507,Andhra Pradesh,India |
|
Primary Sponsor
|
Name |
Svims |
Address |
SVIMS, Alipiri road,Tirupathi,Chittoor |
Type of Sponsor |
Research institution |
|
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 |
DrSumadhu |
svims |
Department of Anesthesiology,
Sri venkateswara institute of medical sciences, Tirupati,
Andhra Pradesh, INDIA Chittoor ANDHRA PRADESH |
9177704349
sumadhu13121991@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institute ethics committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K918||Other intraoperative and postprocedural complications and disorders of digestive system, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Tramadol and Fentanyl |
post-operatively if Numerical Rating Scale (NRS)Score 4, patients will be prescribed inj.Tramadol 2mg/kg intravenously followed by additional doses if requested by patient after an interval of 12 hours. pain between 2 doses of tramadol will be treated with inj.fentanyl 0.5mcg/kg intravenously.NRS Score will be assessed at 0hr,2hr,4hr,6hr,12hr&24hr. |
Comparator Agent |
Two different doses of Dexmedetomidine with ROpivacaine |
patients will be divided into three groups to recieve different doses of Dexmeditomedine(Group R will recieve Normal saline,Group RD1 will recieve 0.5mcg/kg Dexmeditomedine & Group RD2 will recieve 1mcg/kg Dexmeditomedine) along with 30 ml of 0.75% Ropivacaine for Wound infiltration.The total drug volume will be made to 60ml with Normal Saline and will be infiltrated by the surgeon into the surgical wound edges ONE time at the end of surgery. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1.Patients scheduled to undergo elective open abdominal surgeries at SVIMS.
2.Patients belonging to ASA physical status 1,2 and 3.
3.Age group between 18 and 65 years.
|
|
ExclusionCriteria |
Details |
1.Patient refusal to participate in the study.
2.Severe hepatic/cardiac/renal disorders.
3.Pre existing neurological deficits/psychiatric illness/metabolic disorders.
4.Allergic reaction to the study drugs.
5.History of chronic analgesic usage(on oral analgesics for more than one month).
6.Pregnant and lactating mothers.
7.Patients who cannot understand and interpret NRS.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Double Blind Double Dummy |
Primary Outcome
|
Outcome |
TimePoints |
The magnitude of pain using NRS at fixed time interval |
At 0hr,2hr,4hr,6hr,12hr&24hr. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Analgesic requirement in first 24 hours after surgery.
The time to the first request of rescue analgesia.
|
6 months |
|
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
|
Phase 1 |
Date of First Enrollment (India)
|
21/02/2019 |
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 Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
none yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
An incision made in the abdominal wall contributes to severe postoperative pain which may cause the decreased function of the immune system, decreased healing and painful suffering, these changes may probably negatively affect the postoperative recovery pain. Wound infiltration with local anesthetics is one of the multimodal approaches to control postoperative pain after open abdominal surgeries. Ropivacaine is a long-acting amide– local anesthetic, s-enantiomer mainly used for surgery and postoperative pain relief.4 At high doses, it produces surgical anesthesia and at lower doses, it produces analgesia mainly sensory block with a limited and non-progressive motor block. Ropivacaine has a slightly prolonged duration of action than bupivacaine and less cardiotoxic effects. Dexmedetomidine is a strong and highly selective α2-adrenoreceptor agonist which has sedative, analgesic, and sympatholytic properties. It enhances the analgesic efficacy of local anesthetics when added as an adjuvant for wound infiltration. Different doses of dexmedetomidine has been tried as adjuvant to local anaesthetics to prolong post operative analgesia.6,7,8However the optimum dose of dexmedetomidine is yet to be
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