| CTRI Number |
CTRI/2023/01/048883 [Registered on: 11/01/2023] Trial Registered Prospectively |
| Last Modified On: |
10/01/2023 |
| 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
|
PAIN MANAGEMENT IN PERINEAL SURGERIES |
|
Scientific Title of Study
|
A COMPARATIVE EVALUATION OF ULTRASOUND GUIDED CAUDAL BLOCK WITH ROPIVACAINE VERSUS ROPIVACAINE WITH DEXAMETHASONE FOR POST OPERATIVE ANALGESIA IN ADULT PERINEAL SURGERY:A PROSPECTIVE RANDOMISED DOUBLE BLINDED STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR VARSHA GUPTA |
| Designation |
DNB TRAINEE |
| Affiliation |
TATA MOTORS HOSPITAL |
| Address |
OT COMPLEX 1ST FLOOR DEPARTMENT OF ANAESTHESIA TATA MOTORS HOSPITAL KHARANGAJHAR TELCO COLONY JAMSHEDPUR JHARKHAND
OT COMPLEX 1ST FLOOR DEPARTMENT OF ANAESTHESIA TATA MOTORS HOSPITAL KHARANGAJHAR TELCO COLONY JAMSHEDPUR JHARKHAND
Purbi Singhbhum
JHARKHAND
831004
India |
| Phone |
7078137274 |
| Fax |
|
| Email |
varshaguptarocks09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR BHUPENDRA KR SINGH |
| Designation |
CONSULTANT |
| Affiliation |
TATA MOTORS HOSPITAL |
| Address |
OT COMPLEX 1ST FLOOR DEPARTMENT OF ANAESTHESIA TATA MOTORS HOSPITAL KHARANGAJHAR TELCO COLONY JAMSHEDPUR JHARKHAND
OT COMPLEX 1ST FLOOR DEPARTMENT OF ANAESTHESIA TATA MOTORS HOSPITAL KHARANGAJHAR TELCO COLONY JAMSHEDPUR JHARKHAND
Purbi Singhbhum
JHARKHAND
831004
India |
| Phone |
9899204523 |
| Fax |
|
| Email |
bks325918@tatamotors.com |
|
Details of Contact Person
Public Query
|
| Name |
VARSHA GUPTA |
| Designation |
DNB TRAINEE |
| Affiliation |
TATA MOTORS HOSPITAL |
| Address |
OT COMPLEX 1ST FLOOR DEPARTMENT OF ANAESTHESIA TATA MOTORS HOSPITAL KHARANGAJHAR TELCO COLONY JAMSHEDPUR JHARKHAND
OT COMPLEX 1ST FLOOR DEPARTMENT OF ANAESTHESIA TATA MOTORS HOSPITAL KHARANGAJHAR TELCO COLONY JAMSHEDPUR JHARKHAND
Purbi Singhbhum
JHARKHAND
831004
India |
| Phone |
7078137274 |
| Fax |
|
| Email |
varshaguptarocks09@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
TATA MOTORS HOSPITAL |
| Address |
Tata Motors Hospital,Kharangajhar,Telco Colony,Jamshedpur, Jharkhand |
| 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 VARSHA GUPTA |
TATA MOTORS HOSPITAL |
OT COMPLEX 1ST FLOOR DEPARTMENT OF ANAESTHESIA MOTORS HOSPITALTELCO COLONY JAMSHEDPUR 831004
Purbi Singhbhum
JHARKHAND |
7078137274
varshaguptarocks09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE TATA MOTORS JAMSHEDPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R190||Intra-abdominal and pelvic swelling, mass and lump, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
Nil |
| Comparator Agent |
ROPIVACAINE |
20ml(18ml 0.25% ROPIVACAINE + 2ml Normal Saline) given as stat dose Postoperatively in the caudal space via ultrasound guidance. |
| Comparator Agent |
ROPIVACAINE WITH DEXAMETHASONE |
20ml (18ml 0.25% ROPIVACAINE + 8mg DEXAMETHASONE) given as stat dose post-operative Period in the caudal space using ultrasound guidance |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients informed consent
2 Age of patients 18-70 years
3 Patients undergoing perineal surgery
4 ASA GRADE 1 to 3 |
|
| ExclusionCriteria |
| Details |
1 Patient refusal
2 A history of drug allergy or local anaesthetic
systemic toxicity
3 Uncontrolled Diabetes Mellitus
4 Contraindications to caudal block
5 Anatomical abnormality
6 Block failure |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia between the 2 groups. |
Duration of analgesia between the 2 groups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total amount of tramadol consumption. |
24 hours. |
| Pain Score (NRS) |
24 hours |
| Adverse effects and complications |
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)
|
12/01/2023 |
| 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)
|
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)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 09-01-2023 and end date provided 09-02-2024?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Caudal epidural block is a commonly used technique for surgical anaesthesia in children and chronic pain management in adults. Using conventional blind technique, the failure rate of caudal epidural block in adults is high even in experienced hands. This high failure rate could be attributed to anatomical variations that make locating sacral hiatus difficult. With the advent of ultrasonography it has been demonstrated to be highly effective in accurately guiding the needle entering the caudal epidural space and resurgence of interest in caudal block in adult for chronic pain relief and postoperative analgesia. While excellent pain relief, minimal side effects, and high patient satisfaction are the advantages; short duration after a single injection is the single main disadvantage even with long‑acting local anaesthetics such as bupivacaine.Therefore, various adjuvants like opioids, alpha 2 agonist and steroids have been added to prolong the duration of caudal block. Dexamethasone potentiates analgesia of the caudal block by regulating transcription factor nuclear factor-kB and inhibits central sensitization after surgery. This study is designed to compare the analgesic efficacy of plain 20ml of 0.25% ropivacaine versus dexamethasone 8mg added as an adjuvant to ropivacaine for caudal block in adult perineal surgeries, in terms of the duration of post-operative analgesia, patients satisfaction and any side effects. |