| CTRI Number |
CTRI/2020/12/029557 [Registered on: 03/12/2020] Trial Registered Prospectively |
| Last Modified On: |
28/11/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ultrasound guided Erector spinae plane block with Versus without Clonidine for perioperative breast analgesia. |
|
Scientific Title of Study
|
Ultrasound guided Erector spinae plane block with Versus without Clonidine for opioid sparing perioperative breast analgesia: A Prospective Double-Blinded Randomized Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
kulbhushan saini |
| Designation |
assistant professor |
| Affiliation |
pgimer, chandigarh |
| Address |
department of anaesthesia,
4th floor, A block, Nehru hospital, pgimer
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9968856948 |
| Fax |
|
| Email |
kulbhushansaini007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
kulbhushan saini |
| Designation |
assistant professor |
| Affiliation |
pgimer, chandigarh |
| Address |
department of anaesthesia,
4th floor, A block, Nehru hospital, pgimer
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9968856948 |
| Fax |
|
| Email |
kulbhushansaini007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
kulbhushan saini |
| Designation |
assistant professor |
| Affiliation |
pgimer, chandigarh |
| Address |
department of anaesthesia,
4th floor, A block, Nehru hospital, pgimer
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9968856948 |
| Fax |
|
| Email |
kulbhushansaini007@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
pgimer |
| Address |
pgimer, Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 kulbhushan saini |
nehru hospital, ot complex, 4th floor, general surgery ot |
pgimer chandigarh
Chandigarh
CHANDIGARH |
9968856948
kulbhushansaini007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICAL COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C501||Malignant neoplasm of central portion of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A : Patients will receive Erector Plane Block with LA 0.3% Ropivacaine Alone. |
The block will be performed after induction of general anaesthesia. With the patient in the prone position, USG-guided ESPB will be performed using a linear array probe of 6-13 MHz frequency. Initially the T4 spinous process will be marked marked with skin, by counting downwards from the C7 spinous process. Then the probe will be placed in longitudinal parasagittal orientation 3 cm lateral to the midline to identify the tip of the transverse process . The Epidural (Tuohy) needle 18 G will be inserted in the cranial to caudal direction in-plane with the ultrasound beam to gently contact the Transverse process. . Correct needle tip position will be verified by injection of 0.5 to 1 ml of 0.9% normal saline and visualisation of linear spread of injectate solution separating the erector spinae muscle from the transverse processes . Then, either 20 ml of ropivacaine 0.375% Alone will be injected just below the erector spinae muscle, just above the transverse process. |
| Intervention |
The patients selected for the study will be randomly divided into two Groups A and B using
Group A : Patients will receive Erector Plane Block with LA Alone.
Group B: Patients will receive Erector Plane Block with Local Anesthetic 0.3% ropivacaine and added clonidine
|
The block will be performed after induction of general anaesthesia. With the patient in the prone position, USG-guided ESPB will be performed using a linear array probe of 6-13 MHz frequency. Initially the T4 spinous process will be marked marked with skin, by counting downwards from the C7 spinous process. Then the probe will be placed in longitudinal parasagittal orientation 3 cm lateral to the midline to identify the tip of the transverse process . The Epidural (Tuohy) needle 18 G will be inserted in the cranial to caudal direction in-plane with the ultrasound beam to gently contact the Transverse process. . Correct needle tip position will be verified by injection of 0.5 to 1 ml of 0.9% normal saline and visualisation of linear spread of injectate solution separating the erector spinae muscle from the transverse processes . Then, either 20 ml of ropivacaine 0.375% with adjuvant clonidine will be injected just below the erector spinae muscle, just above the transverse process. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. ASA grade I-II healthy Adults
2. Patients above the age of 18 years to 65 years
3. Patients who can understand the VAS scale.
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal to participate
2. Patient unable to co-operate
3. Local sepsis at the site of block
4. Coagulability/ patient on anti-coagulants
5. Known hypersensitivity to local anaesthetics or morphine
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The duration of opioid free analgesia of Erector Spinae Plane Block with local anesthetic alone versus local anesthetic mixture with added clonidine for perioperative pain relief in patients undergoing Breast surgeries |
00 hours, 02 hours, 06 hours, 12 hours, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the total rescue opioid or opioid equivalent drugs required in the first 24 hours after surgery.
2. To compare the complications associated with the this regional anaesthetic technique.
|
24 hours |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2020 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will assess the significance of adding clonidine to the anesthetic mixture for women undergoing breast surgery under ESPB in terms of opioid and other analgesic consumption. secondary objectives were to assess pain scores, perioperative hemodynamic stability , return to daily activity. |