| CTRI Number |
CTRI/2025/01/079207 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To find the difference between two drugs given by erector spinae block, which decreases pain after total laparoscopic hysterectomy surgery. |
|
Scientific Title of Study
|
Comparison of Analgesic Efficacy of Dexamethasone and Dexmedetomidine as an Adjuvant to 0.375 percent Ropivacaine in Lower Thoracic Erector Spinae Plane Block for Total Laparoscopic Hysterectomy: A Prospective, Randomised, Double blind Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Beena Thada |
| Designation |
Associate professor |
| Affiliation |
JLN MEDICAL COLLEGE, AJMER, RAJASTHAN |
| Address |
Department of Anaesthesia,New ot, 1st floor,JLN Hospital, Kalabhag, Ajmer, Rajasthan. PIN code 305001
Ajmer
RAJASTHAN
305001
India |
| Phone |
9352260425 |
| Fax |
|
| Email |
drbeenaverma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Beena Thada |
| Designation |
Associate professor |
| Affiliation |
JLN MEDICAL COLLEGE, AJMER, RAJASTHAN |
| Address |
Department of Anaesthesia,New ot, 1st floor,JLN Hospital, Kalabhag, Ajmer, Rajasthan. PIN code 305001
Ajmer
RAJASTHAN
305001
India |
| Phone |
9352260425 |
| Fax |
|
| Email |
drbeenaverma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Beena Thada |
| Designation |
Associate professor |
| Affiliation |
JLN MEDICAL COLLEGE, AJMER, RAJASTHAN |
| Address |
Department of Anaesthesia,New ot, 1st floor,JLN Hospital, Kalabhag, Ajmer, Rajasthan. PIN code 305001
Ajmer
RAJASTHAN
305001
India |
| Phone |
9352260425 |
| Fax |
|
| Email |
drbeenaverma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology,JLN Medical College, kalabhag, Ajmer Rajasthan. 305001 |
|
|
Primary Sponsor
|
| Name |
JLN Medical College |
| Address |
Kalabhag, Ajmer, Rajasthan , India 305001 |
| 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 Manjunath M Doddaganiger |
JLN Medical College and Hospital, Ajmer, Rajasthan |
Department of anaesthesiology, new ot, 1st floor, JLN hospital, Kalabhag, Ajmer, Rajasthan
Ajmer
RAJASTHAN |
8904232737
manjunathd889@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical 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 |
| Intervention |
Group A - Bilateral erector spinal plane block using injection ropivacaine 0.375% (20 ml)+ injection dexmedetomidine 0.5 mcg/kg (1ml), total 21 ml is given |
Patients receives bilateral erector spinae plane block using injection ropivacaine 0.75% 10 ml is diluted to 20 ml using normal saline mixed with injection dexmedetomidine 0.5mcg/kg diluted to 1 ml using normal saline, total 21 ml of above solution is given at the level of T10 spinous process under ultrasound guidance |
| Comparator Agent |
Group B - Bilateral erector spinar plane block using injection ropivacaine 0.375% (20ml) + injection dexamethasone 4 mg (1ml), total 21 ml is given |
Patients receives bilateral erector spinae plane block using injection ropivacaine 0.75% 10 ml is diluted to 20 ml using normal saline mixed with inj dexamethasone 4 mg (1 ml), total 21 ml of solution is given at the T10 spinous process under ultrasound guidance |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Patients belonging to ASA PS class I and II.
Patients undergoing Total laparoscopic hysterectomy of duration 1.5-2 hours in operation theatre with haemoglobin at least 9 gm/dl.
Patients free from any associated acute or chronic systemic illness. |
|
| ExclusionCriteria |
| Details |
Uncooperative patients.
Patients with chronic pain or on long term analgesics.
Any known hypersensitivity or contraindication to ropivacaine.
Local pathology at the site of injection or disability limiting the performance of block (deformity of spine).
Patients receiving beta blockers or cardiac drugs .
History of convulsions, allergy to drugs used , bleeding disorder, severe neurological deficits, thyroid disorder.
Patient with a history of respiratory, cardiac, hepatic, or renal disease ( necessitating classification in ASA class III or above.
Patients having a history of significant neurological, psychiatric, or neuromuscular disorder.
Patients with deranged PT-INR . |
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare postoperative time to first tramadol request . |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess and compare :
Visual analogue scale (VAS) score at rest and movement.
Total amount of tramadol consumption in first 48 hours postoperatively.
Onsets of sensory block.
Duration of sensory block.
Intraoperative fentanyl consumption.
Haemodynamic parameters (HR,SBP,DBP,MBP).
Sedation score.
Any side effects ( nausea, vomiting, bradycardia, hypotension, respiratory depression). |
VAS score 1-10
Time in hours.
|
|
|
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 2 |
|
Date of First Enrollment (India)
|
02/02/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to compare the analgesic efficacy of dexamethasone and dexmedetomidine as an adjuvant to 0.375% ropivacaine in lower thoracic erector spinae plane block for total laparoscopic hysterectomy. This study will be conducted in patients undergoing anaesthesia for elective total laparoscopic hysterectomy at Jawaharlal Nehru Medical College, Ajmer, Rajasthan. This is hospital based prospective randomised double blind study of total sample size 90 and conducted in two groups A and B (45 each), after computer generated randomisation and concealed allocation. Patients with age between 40-60 years old , belonging to ASA PS class I and II, with haemoglobin at least 9 gm/dl, and free from acute or chronic illness.
Primary objective is to assess and compare the postoperative time to opioid request. Secondary objectives are pain score at rest and movement, total amount of opioid consumption in first 48 hours postoperatively, duration of sensory block, sedation score and any side effects noted.
In this study, total 90 patients undergoing total laparoscopic hysterectomy are allocated randomly into two groups (45 in each group ) and one group receives injection 4 mg dexamethasone mixed with injection ropivacaine and another group receives injection dexmedetomidine 0.5 mcg/Kg mixed with injection ropivacaine given bilaterally in the erector spinae plane identified under ultrasound guidance and after 15-20 mins the sensory effect is checked by pin prick method, along with the onset of sensory block.
Followed by administration of general anaesthesia and Intraoperative requirement of opioid analgesic is noted and change in hemodynamic parameters like blood pressure, mean arterial pressure, oxygen saturation by 20% above the baseline is noted.
After extubation patients are shifted to postoperative care unit, where they are monitored, opioid requirement, duration of sensory block, any side effects like nausea, vomiting, bradycardia, hypotension noted.
Data will be stored in Ms-Excel and will analyse with STATA version 14. The results between two groups will be compared using unpaired t-test or Wilcoxan signed rank test as per the data shape. The results were statistical significant based on p value < 0.05.
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