| CTRI Number |
CTRI/2015/10/006283 [Registered on: 20/10/2015] Trial Registered Prospectively |
| Last Modified On: |
08/10/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pain relief after chest surgery |
|
Scientific Title of Study
|
A randomized evaluation of intercostal block as an adjunct to epidural analgesia for post-thoracotomy pain |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priya Ranganathan |
| Designation |
Associate Professor |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
Department of Anaesthesia
Tata Memorial Hospital
Department of Anaesthesia
Tata Memorial Hospital
Mumbai
MAHARASHTRA
400012
India |
| Phone |
919967971878 |
| Fax |
912224146937 |
| Email |
drpriyaranganathan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asharab Tadvi |
| Designation |
Junior registrar |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
Department of Anaesthesia
Ernest Borges Road
Parel
Tata Memorial Hospital
Mumbai
MAHARASHTRA
400012
India |
| Phone |
91-22-24177000 |
| Fax |
912224146937 |
| Email |
asharab@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priya Ranganathan |
| Designation |
|
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
Department of Anaesthesia
Tata Memorial Hospital
Department of Anaesthesia
Tata Memorial Hospital
MAHARASHTRA
400012
India |
| Phone |
919967971878 |
| Fax |
912224146937 |
| Email |
drpriyaranganathan@gmail.com |
|
|
Source of Monetary or Material Support
|
| applied for intramural funding from TATA MEMORIAL HOSPITAL, PAREL, MUMBAI 400012 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Not applicable] |
|
|
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 |
| Priya Ranganathan |
Tata Memorial Hospital |
Department of Anaesthesia, Tata memorial Hospital,Ernest Borges Road, Parel, MUmbai 400012
Mumbai
MAHARASHTRA |
919967971878
912224146937
drpriyaranganathan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-I, Tata Memorial Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
undergoing postero-lateral thoracotomy for tumours of the thoracic cavity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
No intervention |
| Intervention |
Intercostal block group |
Intercostal block with 0.25% bupivacine on four intercostal nerves, each of the two nerves above and below the level of thoracotomy, with 2 ml per nerve using a 22-gauge needle. The intercostal nerve block will be given by the operating surgeon under direct vision, between the dorsal end of the parietal pleura incision and the costovertebral junction. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I, II and III patients undergoing standard posterolateral thoracotomy
|
|
| ExclusionCriteria |
| Details |
1. Refusal of consent
2. Contra-indication to epidural
3. Contra-indication to any of the study drugs (lignocaine, bupivacaine, fentanyl, diclofenac, paracetamol)
4. Additional surgical incisions during the same sitting (except mediastinoscopy)
5. Previous thoracotomy/ thoracoscopy
6. Use of pain medications in the pre-operative period
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain score
|
2 to 4 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain score |
18 to 24 hours after surgery |
| Analgesic requirements |
first 24 hours after surgery |
| Maximum volume achieved on spirometry |
18 to 24 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2015 |
| Date of Study Completion (India) |
17/11/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Intercostal block with local anaesthetic has been suggested as an alternative to epidural analgesia for post-thoracotomy pain. We hypothesize that the addition of intercostal block to epidural analgesia in patients undergoing open postero-lateral thoracotomy will reduce pain scores and post-operative analgesic requirements |