| CTRI Number |
CTRI/2023/04/051463 [Registered on: 11/04/2023] Trial Registered Prospectively |
| Last Modified On: |
30/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing pain relief between dexmedetomidine and dexamethasone with ropivacaine after costotransverse block in patients undergoing breast surgeries. |
|
Scientific Title of Study
|
Comparative evaluation of Dexmedetomidine versus Dexamethasone as adjuvant to ropivacaine 0.75% in ultrasound guided single shot costotransverse block for analgesia in unilateral breast
surgeries: A Randomized Clinical Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Geetanshu Gupta |
| Designation |
Post Graduate Student |
| Affiliation |
Government Medical College and Hospital, Sector 32 Chandigarh. |
| Address |
Department of Anaesthesia and Intensive care, Block D, Level 5,
GMCH, Sector 32B, Chandigarh
Chandigarh
CHANDIGARH
160030
India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9946643043 |
| Fax |
|
| Email |
dr.geetanshugupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital, Sector 32 Chandigarh. |
| Address |
Department of Anaesthesia and Intensive care, Block D, Level 5,
GMCH, Sector 32B, Chandigarh
Chandigarh
CHANDIGARH
160030
India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646004171 |
| Fax |
|
| Email |
swatirohitjindal604@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital, Sector 32 Chandigarh. |
| Address |
Department of Anaesthesia and Intensive care, Block D, Level 5,
GMCH, Sector 32B, Chandigarh
Chandigarh
CHANDIGARH
160030
India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646004171 |
| Fax |
|
| Email |
swatirohitjindal604@gmail.com.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive care, Block D, Level 5, GMCH, Sector 32B,
Chandigarh |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia and Intensive care |
| Address |
Department of Anaesthesia and Intensive care, Block D, Level 5,
GMCH, Sector 32B, Chandigarh |
| 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 Geetanshu Gupta |
Government Medical College and Hospital, Sector 32B, Chandigarh |
Department of
Anaesthesia and
Intensive care, Block D,
Level 5, GMCH, Sector
32B, Chandigarh
Chandigarh
CHANDIGARH
Chandigarh
CHANDIGARH |
9946643043
dr.geetanshugupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
Dexamethasone as an adjuvant
to ropivacaine |
Patients randomized to this
group will receive single shot
costotransverse block with 0.75%
ropivacaine and
dexamethasone 0.1 mg/kg and will be
observed for 24hours
postoperatively.
Dose of Dexamethasone- 0.1mg/kg
Frequency- Single shot
Route- Costotransverse block
Duration- observation for 24hours. |
| Intervention |
Dexmedetomidine as an
adjuvant to ropivacaine |
Patients randomized to this
group will receive single shot
costotransverse block with 0.75%
ropivacaine and
dexmedetomidine 1mcg/kg and
will be observed for 24hours
postoperatively.
Dose of Dexmedetomidine- 1mcg/kg
Frequency- Single shot
Route- Costotransverse block
Duration- observation for 24hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
American Society of Anesthesiologists (ASA) class I-II
Age more than 18 years at the date of inclusion
Females posted for breast surgery
Who have received thorough information and have signed the informed written consent form |
|
| ExclusionCriteria |
| Details |
Patient refusal
ASA III- IV including patient with severe respiratory,cardiovascular, liver and metabolic or pre-existing neurological deficit
Skin infection at puncture site
Allergy to study drugs
Recent history of use of analgesic/steroid drugs
Pregnant patient
History of psychiatric illness and substance abuse.
Morbid obesity BMI >40 kg/m2
Coagulation abnormalities (INR>1.5,thrombocytopenia) |
|
|
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 evaluate the efficacy of dexmedetomidine
versus dexamethasone as an adjuvant to
ropivacaine on pain relief after costotransverse
block by determining the quality of recovery assessed using Quality of Recovery(QoR-15) scale at 24 hour post operatively. |
At 24 hrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the time for first requirement of analgsia.
Total cumulative dose of rescue analgesic
(tramadol) consumption in the 24 h after surgery.
VAS scores at rest and on arm movements.
Patient satisfaction with block.
Future willingness to undergo repeat peripheral nerve block.
Note any side effects. |
1hr, 4hr, 8hr, 12hr, 24hr. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
15/04/2023 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Breast surgery is one of the most commonly performed surgery in women. With the recently introduced Costotransverse block (CTB), this study is designed to establish the postoperative analgesic efficacy of single shot CTB by adding either dexmedetomidine or dexamethasone as adjuvant with ropivacaine. 30 patients will be allocated into each group. Intervention group 1 (Group CTB-SONE): Patients will receive single shot costotransverse block with 15 ml of 0.75%ropivacaine with 0.1mg/kg dexamethasone to make total volume of 18ml. Intervention group 2 (Group CTB-DINE): Patients will receive single shot costotransverse block with 15ml of 0.75%ropivacainewith dexmedetomidine 1 mcg/kg to make total volume of 18ml. On the day of surgery, an intravenous (IV) line will be started at 2ml/kg through 20 G cannula. Basic monitoring including electrocardiogram, peripheral oxygen saturation (spo2), non-invasive blood pressure (NIBP), heart rate (HR) and capnography (after intubation) will be done. The block will be given after the induction of anaesthesia and before the start of the surgical procedure. The same general anaesthesia plan will be applied to all patients in both groups. Tyhe patient will be induced with propofol (2-3mg/kg), fentanyl (1.5-2ug/kg) followed by vecuronium bromide (0.1ug/kg) to facilitate endotracheal intubatuion. Anaesthesia will be maintained with oxygen, nitrous oxide, sevoflurane (0.6-1 MAC) or propofol infusion (50-150 ug/kg/min). The patients’s HR, NIBP, SpO2 will be recorded before the block, at the time of block and every 5 min up to 30 min after the block. All the patients will be reversed and after extubation will be shifted to the post-operative anaesthesia care unit and monitored for 2 h, after which patient will be shifted to ward and will be monitored upto 24 h postoperatively. The primary outcome measure of the study is to determine the quality of recovery, assessed using the Quality of Recovery (QoR-15) scale at 24 h post operatively. The time from institution of block to the time for the first analgesic request in the post-opeartive period will be recorded. the pain score on a VAS at rest and on arm movement will be monitored and the patient satisfaction and future willingness to undergo repeat peripheral nerve block will also be recorded at regular intervals for a period of 24 h.
|