| CTRI Number |
CTRI/2011/09/001998 [Registered on: 09/09/2011] Trial Registered Retrospectively |
| Last Modified On: |
06/09/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of the efficacy of three different formulations of local anaesthetics during thyroid surgery |
|
Scientific Title of Study
|
Comparison of three different formulations of local anaesthetics for cervical epidural anaesthesia during thyroid surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gaurav Jain |
| Designation |
Assistant Professor |
| Affiliation |
Teerthankar Mahaveer Medical college |
| Address |
Department of anaesthesia, Teerthankar Mahaveer Medical college, Delhi Road, Bagarpur, Moradabad
E-203,Faculty block, Teerthankar Mahaveer Medical College, Delhi Road, Bagarpur,Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
915912360170 |
| Fax |
|
| Email |
gauravhld@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gaurav Jain |
| Designation |
Assistant Professor |
| Affiliation |
Teerthankar Mahaveer Medical college |
| Address |
Department of anaesthesia, Teerthankar Mahaveer Medical college, Delhi Road, Bagarpur, Moradabad
E-203,Faculty block, Teerthankar Mahaveer Medical College, Delhi Road, Bagarpur,Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
915912360170 |
| Fax |
|
| Email |
gauravhld@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gaurav Jain |
| Designation |
Assistant Professor |
| Affiliation |
Teerthankar Mahaveer Medical college |
| Address |
Department of anaesthesia, Teerthankar Mahaveer Medical College, Delhi Road, Bagarpur, Moradabad
E-203,Faculty block, Teerthankar Mahaveer Medical College, Delhi Road, Bagarpur,Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
915912360170 |
| Fax |
|
| Email |
gauravhld@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Other [Nil] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Gaurav Jain |
Department of anaesthesia, Banaras Hindu university |
Sir Sunder lal Hospital,Banaras Hindu University-244001
Varanasi
Varanasi
UTTAR PRADESH |
9936871711
gauravhld@gmail.com |
| Gaurav Jain |
Department of anaesthesia, Teerthankar Mahaveer medical college |
Department of anaesthesia, Teerthankar Mahaveer medical college, Delhi road, bagarpur, moradabad
Moradabad
UTTAR PRADESH |
9936871711
gauravhld@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Banaras Hindu university |
Approved |
| Institutional ethical commitee, Teerthankar mahaveer medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Posted for thyroid surgeries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
bupivacaine (0.25%) |
10 ml of drug injected via epidural cathetor for cervical epidural anaesthesia |
| Intervention |
Cervical epidural cathetor placement |
On arrival to operative room, patients were placed in the right lateral decubitus position with the neck flexed and chin on chest. The cervical epidural space was identified with an 18 gauge Tuohy epidural needle, at C7 – T1 interspace using loss of resistance technique via a midline cephalad approach. A 19-gauge end-holed catheter was then introduced 4 cm into the epidural space. After negative aspiration, catheter was tunnelled subcutaneously and patients were laid supine. The cephalad position of the catheter’s tip was confirmed radiographically using Omnipaque dye (2ml). |
| Comparator Agent |
lidocaine (1%) |
10 ml of drug injected via epidural cathetor for cervical epidural anaesthesia |
| Comparator Agent |
ropivacaine (0.5%) |
10 ml of drug injected via epidural cathetor for cervical epidural anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
euthyroid cases of ASA Physical Status I - III,
height 145-165 cm,
body mass index 25±10%,
posted for thyroid surgeries |
|
| ExclusionCriteria |
| Details |
deranged coagulation profile,
H/o allergy to any local anaesthetic drugs,
retrosternal goitre,
cardiorespiratory disease,
any contraindication to regional anaesthesia. |
|
|
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 |
| pulmonary [vital capacity (VC), peak expiratory force (PEF), and fraction of the vital capacity expired during the first second of a forced expiration (FEV1)] and hemodynamic parameters (Heart rate, Mean arterial pressure) |
At baseline, 30 min post-CEA and end of the surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| blockade quality, and complications |
The block profile was evaluated at 5 min intervals for first 30 min after the induction of CEA and at 1hr intervals thereafter. Complication evaluated during perioperative period |
|
|
Target Sample Size
|
Total Sample Size="81"
Sample Size from India="81"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2009 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Objective: To compare the efficacy and safety of local anaesthetics using lidocaine (1%), bupivacaine (0.25%) and ropivacaine (0.5%) under cervical epidural anaesthesia (CEA) for thyroid surgery.
Material and Methods: In a prospective, randomized fashion, 81 cases were selected for thyroid surgery under CEA. They were assigned to one of three groups: group L, B &R to receive 10 ml of 1% lidocaine; 0.25% bupivacaine, and 0.5% ropivacaine, respectively. We compared their efficacy in terms of pulmonary and hemodynamic parameters, blockade quality, and complications.
Results: Of the total, 74 cases completed the study successfully. Sensory block attained the median dermatomal range of C2-T4/T5 in all the groups. Motor block was intense in ropivacaine group. Cardiorespiratory parameters decreased significantly in all the groups; however, none of the patients had any major complications except for bradycardia in 2 cases. Among the measured variables, the decrease in HR and PEF was more in lidocaine group while FVC and FEV1 declined to a greater extent in ropivacaine group. The lidocaine group required significantly more epidural top-ups compared to the other two groups.
Conclusion: We conclude that cervical epidural route can be safely used for thyroid surgery of patients without pre-existing cardiorespiratory disease, using either of local anaesthetics chosen for our study. Under the selected dose and concentrations, the decrease in cardiorespiratory parameters was lesser with bupivacaine.
Note: Trial was headed by the principal investigator in 2 different hospitals but not simultaneously. Initially the trial was started in BHU from Aug 2009 - Dec 2010 (55 cases) and then at Teerthankar Mahaveer Medical College (26 cases). |