| CTRI Number |
CTRI/2018/10/015912 [Registered on: 05/10/2018] Trial Registered Prospectively |
| Last Modified On: |
13/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of peri-operative intravenous lidocaine infusion in postoperative pain and recovery following laparoscopic renal surgeries. |
|
Scientific Title of Study
|
Role of peri-operative intravenous lidocaine infusion in postoperative pain and recovery following laparoscopic renal surgeries: A randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR DINESH J PRAJAPATI |
| Designation |
CONSULTANT ANESTHESIOLOGIST |
| Affiliation |
MULJIBHAI PATEL UROLOGICAL HOSPITAL, |
| Address |
Dept. of Anesthesiology
Muljibhai Patel Urological Hospital,
Near, Dr Virendra Desai Road,
Nadiad.
Kheda
GUJARAT
387001
India |
| Phone |
9879399866 |
| Fax |
|
| Email |
dr_djp2011@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DINESH J PRAJAPATI |
| Designation |
CONSULTANT ANESTHESIOLOGIST |
| Affiliation |
MULJIBHAI PATEL UROLOGICAL HOSPITAL, |
| Address |
Dept. of Anesthesiology,
Muljibhai Patel Urological Hospital,
NEAR, DR VIRENDRA DESAI ROAD,
NADIAD-387001
NEAR, DR VIRENDRA DESAI ROAD,
NADIAD-387001
Kheda
GUJARAT
387001
India |
| Phone |
9879399866 |
| Fax |
|
| Email |
dr_djp2011@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DINESH J PRAJAPATI |
| Designation |
CONSULTANT ANESTHESIOLOGIST |
| Affiliation |
MULJIBHAI PATEL UROLOGICAL HOSPITAL, |
| Address |
Dept of Anesthesiology,
Muljibhai Patel Urological Hospital,
NEAR, DR VIRENDRA DESAI ROAD,
NADIAD-387001
Kheda
GUJARAT
387001
India |
| Phone |
9879399866 |
| Fax |
|
| Email |
dr_djp2011@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Muljibhai Patel Urological Hospital, Nadiad |
|
|
Primary Sponsor
|
| Name |
Muljibhai Patel Urological Hospital Nadiad |
| Address |
Near Dr Virendra Desai Road,
Nadiad-387001 |
| 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 SHAILESH SONI |
MULJIBHAI PATEL UROLOGICAL HOSPITAL |
Department of Anesthesiology,
Muljibhai Patel Urological Hospital
NEAR DR VIRENDRA DESAI ROAD,
NADIAD
Kheda
GUJARAT |
9408599474
sonishail@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Muljibhai Patel Society for Research in Nephro-Urology Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, (2) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
lidocaine 2% preservative free
with placebo control. |
Intravenous Lignocaine 2 % infusion will be started 30 minutes before skin incision and continue it till sugery is over.
Intravenous lidocaine dose is 1.5mg/kg bolus over 10-15minutes follow by infusion 1.5mg/kg/hour.
|
| Comparator Agent |
Plecebo control: Normal saline |
We will compare the outcome of intravenous lidocaine as compare to placebo. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.American Society of Anesthesiologists (ASA) physical status I-III,
2.Undergoing laparoscopic renal surgeries under general anesthesia
|
|
| ExclusionCriteria |
| Details |
1.Allergic to local anesthetics
2.Patients with severe underlying cardiovascular disease,
3.Impaired kidney or liver function,
4.History of drug or alcohol abuse,
5.History of chronic pain or daily intake of analgesics,
6.Uncontrolled medical disease (diabetes mellitus and hypertension),
7.History of intake of non-steroidal anti-inflammatory drugs within 24 hours before surgery,
8.Patients with a history of psychiatric disorder, arrhythmia or seizures.
9.Nephrectomy for renal transplantation
10.Morbid obesity (BMI > 40)
|
|
|
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 |
| The primary outcome are the requirement of inhalational agent, postoperative pain intensity and bowel function. |
Patient will observed till discharged from the hospital. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient comfort and total hospital stay |
first followup |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/11/2018 |
| 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="19"
Months="8"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
1. Apfel CC, Heidrich FM, Jukar-Rao S, et al. Evidence-based analysis of risk factors for postoperative nausea and vomiting. Br J Anaesth. 2012;109:742–7.
2. Suarez MA, Seddighi R, Egger CM, et al. Effect of fentanyl and lidocaine on the end-tidal sevoflurane concentration preventing motor movement in dogs. Am J Vet Res. 2017. January;78(1):12–16. [PubMed]
3. Ortega M, Cruz I. Evaluation of a constant rate infusion of lidocaine for balanced anesthesia in dogs undergoing surgery. Can Vet J. 2011;52:856–860. [PMC free article] [PubMed]
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients will be randomized into two groups using computer-generated randomization tables to receive either intraoperative systemic lidocaine infusion (group L) or normal saline (0.9% NaCl) infusion (group C).Approximately 30 minutes before skin incision, patients in group L (n = 40) received an IV bolus (1.5 mg/kg) of 2% lidocaine. This will be followed by a continuous IV infusion of lidocaine at the rate of 1.5 mg/kg/hr until skin closure.The control group (n = 40) will be received the same volume of bolus and continuous infusion of normal saline. |