CTRI Number |
CTRI/2020/04/024743 [Registered on: 20/04/2020] Trial Registered Prospectively |
Last Modified On: |
17/04/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
Evaluation of effects of lignocaine infusion on postoperative pain relief for abdominal surgery. |
Scientific Title of Study
|
Evaluation of effects of intravenous lignocaine infusion on postoperative analgesia after upper abdominal surgery. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Lokvendra Singh Budania |
Designation |
Associate Professor |
Affiliation |
Kasturba Medical College, Manipal, Manipal Academy Of Higher Education |
Address |
Department of Anaesthesiology
Main OT Complex(Division)
Room- OR offfice
Kasturba Medical College, Manipal, Manipal Academy Of Higher Education, Manipal.
Udupi KARNATAKA 576104 India |
Phone |
9901628947 |
Fax |
|
Email |
drbudania@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Eeshwar M V |
Designation |
Junior Resident |
Affiliation |
Kasturba Medical College, Manipal, Manipal Academy Of Higher Education |
Address |
Department of Anaesthesiology
Main OT Complex(Division)
Room- OR offfice
Kasturba Medical College, Manipal, Manipal Academy Of Higher Education, Manipal.
Udupi KARNATAKA 576104 India |
Phone |
9740122272 |
Fax |
|
Email |
eeshwar.kmc@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Lokvendra Singh Budania |
Designation |
Associate Professor |
Affiliation |
Kasturba Medical College, Manipal, Manipal Academy Of Higher Education |
Address |
Department of Anaesthesiology
Kasturba Medical College, Manipal, Manipal Academy Of Higher Education, Manipal.
KARNATAKA 576104 India |
Phone |
9901628947 |
Fax |
|
Email |
drbudania@gmail.com |
|
Source of Monetary or Material Support
|
Kasturba Hospital , Manipal
Manipal Academy of Higher Education, Manipal,Karnataka , India.PIN 576104 |
|
Primary Sponsor
|
Name |
NA |
Address |
NA |
Type of Sponsor |
Private medical college |
|
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 Lokvendra Singh Budania |
Kasturba Hospital,Manipal |
Department of Anaesthesiology
Main OT Complex(Division)
Room- OR offfice
Kasturba Medical College, Manipal, Manipal Academy Of Higher Education, Manipal. Udupi KARNATAKA |
9901628947
drbudania@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, Kasturba Hospital, Manipal |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (2) ICD-10 Condition: K566||Other and unspecified intestinal obstruction, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Group Lignocaine ( Group L) |
Patients allotted to lignocaine (group L) will receive bolus dose of lignocaine 1.5 mg/kg through a dedicated intravenous line followed by an infusion@ 1.5mg/kg/hr. Infusion will continue intraoperatively at the same rate until skin closure, following which the rate will be reduced to 1 mg/kg/hr and continue in postoperative period for 24 hours |
Comparator Agent |
Group Saline ( Group S) |
Patients allotted to Saline (Group S) will receive bolus dose of Saline 1.5 mg/kg through a dedicated intravenous line followed by an infusion@ 1.5mg/kg/hr. Infusion will continue intraoperatively at the same rate until skin closure, following which the rate will be reduced to 1 mg/kg/hr and continue in postoperative period for 24 hours. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
Patients in age groups 18- 70
Healthy patients belonging to ASA PS I and II
Patients undergoing elective upper abdominal surgery.
|
|
ExclusionCriteria |
Details |
Inability to understand preoperative instructions regarding use of PCA pump or pain score
Planned elective postoperative mechanical ventilation
Patients known to be on anti-arrhythmic drug therapy
History of COPD, cardiac, hepatic, renal or nervous system disorder
Known allergy to lignocaine
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
TIME INTERVAL between skin closure and first morphine PCA request.
TOTAL MORPHINE CONSUMPTION at the end of 2nd, 6th, 12th, 24th and 36th postoperative hour.
|
Immediate postoperative period
36 hours after surgery
|
|
Secondary Outcome
|
Outcome |
TimePoints |
PAIN SCORE (NRS) at rest, on deep inspiration, cough and movement (side to side or leg raising) at the end of 2nd, 6th, 12th, 24th and 36th postoperative hour.
Any complaints of –perioral numbness, light headedness.
Sedation level
|
Immediate postoperative period
36 hours after surgery |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
20/04/2020 |
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="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Not Yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
The pain and
discomfort after major surgical procedures are well known. Despite advances in
knowledge of pathophysiology, pharmacology of analgesics and the development of
more effective techniques for post-operative pain control, many patients
continue to experience appreciable discomfort. Patients undergoing major
abdominal operations experience severe pain and marked respiratory impairment
because of pain in the postoperative period.4
We are
increasingly becoming aware of the risks associated with the use of invasive
techniques in the treatment of postoperative pain. Epidural infusions are
certainly more expensive, cumbersome and invasive than intravenous infusions.
Furthermore, modern thromboprophylaxis practice with low molecular weight
heparins often preclude the use of continuous epidural therapy because of
concern over risk of epidural bleeding and hematoma. It is becoming
increasingly apparent that local anaesthetic such as lignocaine in the systemic
circulation can profoundly alter post-operative pain. Intravenous lignocaine in the therapeutic
dose as used for cardiac arrhythmias treatment, have been shown to reduce
postoperative pain scores and opioid consumption; the presence of these drugs
in the circulation for only a few hours can suppress pain for days after surgery.
Therefore, intravenous lignocaine is appealing as a simple and inexpensive
method to gain the same benefits as more invasive and costly techniques. |