| CTRI Number |
CTRI/2012/12/003187 [Registered on: 06/12/2012] Trial Registered Retrospectively |
| Last Modified On: |
29/09/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [Pain relief] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of ropivacaine (a local anaesthetic) and ropivacaine with fentanyl (an analgesic) injected adjacent to thoracic vertebra to provide pain relief in patients with multiple rib fractures |
|
Scientific Title of Study
|
Continuous paravertebral infusion of ropivacaine with or without fentanyl for pain relief in unilateral multiple fractured ribs - a prospective randomized double blind evaluation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2010/2832 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Medha Mohta |
| Designation |
Associate Professor |
| Affiliation |
University College of Medical Sciences and Guru Teg Bahadur Hospital |
| Address |
Department of Anaesthesiology and Critical Care,
University College of Medical Sciences and Guru Teg Bahadur Hospital
East
DELHI
110095
India |
| Phone |
9868399626 |
| Fax |
|
| Email |
medhamohta@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr L Emeni Ophrii |
| Designation |
DNB student |
| Affiliation |
University College of Medical Sciences and Guru Teg Bahadur Hospital |
| Address |
Department of Anaesthesiology and Critical Care,
University College of Medical Sciences and Guru Teg Bahadur Hospital
East
DELHI
110095
India |
| Phone |
|
| Fax |
|
| Email |
eophrii@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Medha Mohta |
| Designation |
Associate Professor |
| Affiliation |
University College of Medical Sciences and Guru Teg Bahadur Hospital |
| Address |
Department of Anaesthesiology and Critical Care,
University College of Medical Sciences and Guru Teg Bahadur Hospital
East
DELHI
110095
India |
| Phone |
9868399626 |
| Fax |
|
| Email |
medhamohta@hotmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi 110095 |
|
|
Primary Sponsor
|
| Name |
University College of Medical Sciences and Guru Teg Bahadur Hospital |
| Address |
University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, Delhi 110095 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr AK Sethi |
Director Professor and Head,
Department of
Anaesthesiology and Critical Care, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi 110095 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Medha Mohta |
Department of Anaesthesiology and Critical Care, UCMS and GTB Hospital |
Department of Anaesthesiology and
Critical Care, 2nd Floor,
OT Block, University
College of Medical
Sciences and Guru Teg
Bahadur Hospital,
Dilshad Garden
East
DELHI |
9868399626
medhamohta@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Academic and Ethical Committee, Guru Teg Bahadur Hospital, Govt of NCT of Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Unilateral multiple rib fractures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Paravertebral ropivacaine |
A bolus dose of ropivacaine 0.5% 0.3ml/kg followed by continuous infusion of ropivacaine 0.375% + adrenaline 5 µg/ml at a rate of 0.1-0.2 ml/kg/hr through paravertebral catheter until achievement of complete pain relief |
| Intervention |
Paravertebral ropivacaine with fentanyl |
A bolus dose of ropivacaine 0.5% 0.3 ml/kg bolus followed by continuous infusion of ropivacaine 0.2% + adrenaline 5 µg/ml + fentanyl 2 µg/ml at a rate of 0.1-0.2 ml/kg/hr through paravertebral catheter until achievement of complete pain relief |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients having three or more unilateral fractured ribs |
|
| ExclusionCriteria |
| Details |
• Unconscious patients
• Patients with unstable cardiac status or severely altered mental status
• Known liver/kidney disease
• Known allergy to local anaesthetic drugs
• Infection at site of needle insertion
• Pre-existing spinal deformity
• Patients having significant trauma outside chest wall, e.g. acute spine or pelvic fracture, severe traumatic brain or spinal cord injury or abdominal visceral injuries
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rescue analgesic (morphine) requirement |
Throughout study period till VAS score at rest and on coughing was not more than 10 to 15 mm for more than 8 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• VAS pain scores at rest and on coughing
• Respiratory rate
• Peak expiratory flow rate
• Arterial oxygen saturation (SpO2)
• PaO2/FiO2 ratio
|
Before administration of block, 30 min after block, every 6 hours on 1st day and then every 8 hours 2nd day onwards |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
18/03/2010 |
| Date of Study Completion (India) |
Date Missing |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This was a prospective, randomized, double blind, parallel group trial to evaluate and compare the analgesic effect of continuous infusions of either ropivacaine 0.375% with adrenaline 5 µg/ml or a combination of fentanyl 2 µg/ml and ropivacaine 0.2% with adrenaline 5 µg/ml in patients with unilateral multiple rib fractures. Drug related side effects, if any, and the outcome in terms of length of ICU and hospital stay and pulmonary complications in the two groups were also compared.
|