| CTRI Number |
CTRI/2018/05/014334 [Registered on: 31/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
30/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to compare the effects of a drug (dexmedetomidine) in chest wall nerve blocks (Pec 1 and Pec 2 blocks) for pain relief during and after surgery in breast cancer patients. |
|
Scientific Title of Study
|
Dexmedetomidine as an adjuvant to bupivacaine in ultrasound guided Pec 1 and Pec 2 blocks for perioperative analgesia in mastectomy patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijit Kumar |
| Designation |
Junior Resident, second year |
| Affiliation |
King George Medical University Lucknow,UP-226003 |
| Address |
Department of Anaesthesiology and Critical Care
King George Medical University
Lucknow,UP-226003
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9936307388 |
| Fax |
|
| Email |
vijitjaiswal3288@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prem Raj Singh |
| Designation |
Assistant Professor |
| Affiliation |
King George Medical University Lucknow,UP-226003 |
| Address |
Department of Anaesthesiology and Critical Care
King George Medical University
Lucknow,UP-226003
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9918478136 |
| Fax |
|
| Email |
dr.p.rajsingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijit Kumar |
| Designation |
Junior Resident, second year |
| Affiliation |
King George Medical University Lucknow,UP-226003 |
| Address |
Department of Anaesthesiology and Critical Care
King George Medical University
Lucknow,UP-226003
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
|
| Fax |
|
| Email |
vijitjaiswal3288@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Vijit Kumar,
Department of Anaesthesiology and Critical Care,
King George Medical University, Lucknow,UP-226003 |
|
|
Primary Sponsor
|
| Name |
Dr Vijit Kumar |
| Address |
Department of Anaesthesiology and Critical Care, King George Medical University,Lucknow,UP-226003 |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vijit Kumar |
King George Medical University,Lucknow,UP-226003 |
Elective operation theatres of Departments of General Surgery,Oncosurgery and Endocrine Surgery,King George Medical University,Lucknow,UP-226003
Lucknow
UTTAR PRADESH |
9936307388
vijitjaiswal3288@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,King George Medical University, Lucknow-226003 |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
1.Female patients in the age group of 18 to 65 years.
2.ASA Grade I or II
3.Patients posted for elective modified radical mastectomy., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupivacaine alone |
Patients in Group B would receive Pec 1 and Pec 2 block with 30 ml 0.25% bupivacaine alone |
| Intervention |
Dexmedetomidine 0.5 microgram per kilogram body weight. |
Patients in Group Bd would receive Pec 1 and Pec 2 block with 30 ml 0.25% bupivacaine with dexmedetomidine 0.5 microgram per kilogram body weight. |
| Intervention |
Dexmedetomidine 1.0 microgram per kilogram body weight. |
Patients in Group BD would receive Pec 1 and Pec 2 block with 30 ml 0.25% bupivacaine with dexmedetomidine 1.0 microgram per kilogram body weight. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients of ASA Grade I or II.
2.Patients posted for elective modified radical mastectomy. |
|
| ExclusionCriteria |
| Details |
1.Patient is not giving informed consent.
2.Patients with BMI>35 kg/square metres.
3.Patients with sensitivity to local anaesthetics.
4.Patients with bleeding disorders or on anticoagulants.
5.Patients with spine or chest wall deformityor pregnancy.
6.Patients with local infection at the site of block.
7.Patients with significant neurological,cardiac,renal,hepatic or pulmonary disease.
8.Patients planned for breast conservative surgery or simple mastectomy with axillary clearance. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
1.Quality of postoperative analgesia which would be assessed using VAS score.
2.Duration of analgesia (time to first rescue analgesia after administration of block).
3.Intraoperative hemodynamic parameters (mean blood pressure and heart rate).
4.Total analgesic consumption intraoperatively and in first 24 hours after surgery. |
1.The VAS score would be assessed at 0,15,30,60 minutes over first 4 hours postoperatively and then at every 2 hours for first 12 hours and at every 4 hours for next 12 hours.
2.Total analgesic consumption intraoperatively and in first 24 hours after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Presence of any adverse effects like hypotension,nausea,vomiting,respiratory depression and sedation score. |
The secondary outcomes are assessed immediately after surgery and for first 24 hours in postoperative period. |
|
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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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
30/04/2018 |
| 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) |
Open to Recruitment |
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Publication Details
|
Not yet published. |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
The study would be done upon a total of 90 patients after approval of hospital ethics committee and obtaining written informed consent from all the patients.Patients would be randomly assigned to one of the three groups with a total of 30 patients in each group:-
Group B would receive Pec 1 and Pec 2 block with 30 ml 0.25% bupivacaine alone. Group Bd would receive Pec 1 and Pec 2 block with 30 ml 0.25% bupivacaine with dexmedetomidine 0.5 microgram per kilogram body weight. Group BD would receive Pec 1 and Pec 2 block with 30 ml 0.25% bupivacaine with dexmedetomidine 1.0 microgram per kilogram body weight.
On arrival in the operating room, baseline vitals of the patient would be recorded.General anaesthesia would be induced with injection of fentanyl 1 microgram per kg i.v. followed by propofol 1.5-2.0 mg/kg i.v. until loss of verbal response.Vecuronium 0.1 mg/kg i.v. would be used to facilitate tracheal intubation.Anaesthesia would be maintained with nitrous oxide 60% in oxygen and isoflurane 1.0%.
One of the investigators would prepare 30 ml of study drug with either of the aforementioned adjuvants according to the assigned group.The patient would receive ultrasound guided Pec 1 and Pec 2 blocks by an experienced anaesthesiologist who would be blinded to the contents of the drug given.
The primary outcomes would be assessed as follows:- 1.Quality of postoperative analgesia which would be assessed using VAS score. 2.Duration of analgesia (time to first rescue analgesia after administration of block). 3.Intraoperative hemodynamic parameters (mean blood pressure and heart rate). 4.Total analgesic consumption intraoperatively and in first 24 hours after surgery.
The secondary outcomes would be presence of any adverse effects like hypotension,nausea,vomiting,respiratory depression, and sedation score.
Data collected from 90 patients (30 in each study group) would be analysed to arrive at the results.
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