| CTRI Number |
CTRI/2021/07/035222 [Registered on: 28/07/2021] Trial Registered Prospectively |
| Last Modified On: |
27/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effect of drugs,Levobupivacaine and Levobupivacaine with clonidine in erector spinae plane block for post operative pain management in patients undergoing open cholecystectomy. |
|
Scientific Title of Study
|
Comparison between 0.25% Levobupivacaine and 0.25% Levobupivacaine with Clonidine in erector spinae plane block in patients undergoing open cholecystectomy: A prospective randomized double blinded study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swagatika Sahoo |
| Designation |
Post Graduate Trainee,MD Anaesthesiology |
| Affiliation |
Midnapore Medical College and Hospital |
| Address |
Department of Anaesthesiology, Midnapore Medical College and Hospital, Vidyasagore Road, Midnapore town, Paschim Medinipur
Medinipur
WEST BENGAL
721101
India |
| Phone |
9337339851 |
| Fax |
|
| Email |
dr.swagatikalipi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Debasish Bhar |
| Designation |
Associate Professor, Department of Anaesthesiology |
| Affiliation |
Midnapore Medical College and Hospital |
| Address |
Department of Anaesthesiology, Midnapore Medical College and Hospital, Vidyasagore Road, Midnapore town, Paschim Medinipur
Medinipur
WEST BENGAL
721101
India |
| Phone |
8617753967 |
| Fax |
|
| Email |
debasish77bhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Asim Kumar Maiti |
| Designation |
Assistant Professor, Department of Anaesthesiology |
| Affiliation |
Midnapore Medical College and Hospital |
| Address |
Department of Anaesthesiology, Midnapore Medical College and Hospital, Vidyasagore Road, Midnapore town, Paschim Medinipur
Medinipur
WEST BENGAL
721101
India |
| Phone |
9233304769 |
| Fax |
|
| Email |
maitiasim1603@gmail.com |
|
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Source of Monetary or Material Support
|
| Office of the Principal,Midnapore Medical College and Hospital, Vidyasagar Road, Midnapore Town,West medinipur, PIN-721101 |
|
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Primary Sponsor
|
| Name |
Office of the Principal Midnapore Medical College And Hospital |
| Address |
Midnapore Medical College and Hospital,Vidyasagore Road, Midnapore Town, paschim Medinipur |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Swagatika sahoo |
Midnapore Medical College and Hospital |
Department of General Surgery, General Surgery Operation Theatre
Medinipur
WEST BENGAL |
9337339851
dr.swagatikalipi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF MIDNAPORE MEDICAL COLLEGE AND HOSPITAL |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.25% levobupivacaine and 0.25% levobupivacaine with clonidine as adjuvant in erector spinae plane block. |
50 patients posted for elective open cholecystectomy will receive 0.25% levobupivacaine and 50 patients will receive clonidine as adjuvant along with levobupivacaine in erector spinae plane block. |
| Intervention |
Erector spinae plane block in patients undergoing open cholecystectomy with levobupivacaine and levobupivacaine with clonidine as adjuvant. |
50 patients will receive 0.25% levobupivacaine and 50 patients will receive 0.25% levobupivacaine with clonidine as adjuvant in erector spinae plane block who are posted for elective open cholecystectomy.Drug volume will be 20 ml and is to be given 4 ml in each space from t5 to t9 on right side. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) ASA physical status grade I grade II
2) Age group between 18-60 years of both sexs
3) Body Mass Index between 18.5 and 24
4) Patients scheduled for elective open cholecystectomy surgery |
|
| ExclusionCriteria |
| Details |
1)Patients with severe cardio-respiratory disease
2)Patients with hepatic and renal disease
3)Patients with neurologic disorder
4)Patients with endocrine disorder
5)Patients with psychiartic problem
6)Thyroid disease
7)Diabetes mellitus
8)Pregnancy
9) Drug allergy to study drugs |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of levobupavacaine only and levobupivacaine with clonidine in erector spinae plane block for post operative anaigesia in patients undergoing open cholesystectomy.Using clonidine as adjuvant may increase the period of postoperative analgesia. |
The quality of post operative analgesia will be assessed by using VAS at 15 min, 30 min and thereafter every 30 minutes till patient complains of VAS more than 4.Inj pentazocin 0.5 mg/kg will be administered intramuscularly when patients complains of VAS more than 4. If pain is not relieved 45 mins after pentazocin then 75 mg of diclofenac sodium will be administered intramuscularly as rescue analgesia.Total dose of analgesic drug will be calculated for first 24 hrs of after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to find out total amount of analgesic drugs used by patient in postoperative period in first 24 hrs. |
VAS score will be assessed at 15 mins, 30 mins and thereafter every 30 minutes till the VAS score becoms more than 4.then toatl amount of analgesics drugs will be calculated in first 24 hrs after completion of surgery. |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/08/2021 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NO PUBBLICATION YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
PROPOSED TOPIC OF RESEARCH:
COMPARISON BETWEEN 0.25%
LEVOBUPIVACAINE AND 0.25% LEVOBUPIVACAINE WITH CLONIDINE IN
ERECTOR SPINAE PLANE BLOCK IN PATIENTS UNDERGOING OPEN
CHOLECYSTECTOMY: A PROSPECTIVE RANDOMIZED DOUBLE BLINDED
STUDY.
OBJECTIVE OF PROPOSED RESEARCH:
Comparison between duration and dosage
of post-operative analgesia in first 24 hours with 0.25% levobupivacaine with and without
clonidine in erector spinae block in open cholecystectomy.
BACKGROUND OF PRESENT STUDY:
Patients undergoing elective open
cholecystectomy under general anesthesia, experience varying degrees of pain and discomfort
at the site of surgery during post-operative period despite of using systemic opioid and
nonopioid analgesics. Post-operative subcostal pain impairs respiratory dynamics resulting in
postoperative respiratory complications. So, patients usually require supplementation of local
anaesthetic in various methods like local infiltration, intercostals nerve block etc. to decrease
post-operative pain and discomfort in addition to general anaesthesia. The erector spinae
plane block is a newer regional anaesthetic technique that can be used to provide analgesia
for many surgical procedures or to manage acute or chronic pain.
METHODOLOGY:
This is a hospital based, double blinded, prospective, randomized
study on patients posted for open cholecystectomy under general anaesthesia with 0.25 %
levobupivacaine as an agent for erector spinae plane block with or without clonidine as an
adjuvant in surgical operating rooms and post-operative ward of the general surgery
department of Midnapore Medical College & Hospital, Paschim Medinipur for a period of 12
months.
EXPECTED OUTCOME:
Erector spinae plane block will increase the duration of
post-operative analgesia and reduce the use of post-operative analgesic drugs. We
expect patients receiving clonidine as adjuvant with levobupivacaine (group B) will have
a longer duration post-operative analgesia compared to patients receiving only
levobupivacaine (group A) |