| CTRI Number |
CTRI/2022/09/045393 [Registered on: 09/09/2022] Trial Registered Prospectively |
| Last Modified On: |
06/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of addition of buprenorphine or dexamethasone or dexmedetomidine to levobupivacaine on postoperative analgesia in transversus abdominis plane block in patients undergoing unilateral inguinal hernia repair |
|
Scientific Title of Study
|
“Effect of Addition of Buprenorphine or Dexamethasone or Dexmedetomidine to Levobupivacaine on Postoperative Analgesia in Ultrasound guided transversus abdominis plane block in patients undergoing unilateral Inguinal Hernia Repair: a Prospective Randomized Double Blind Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
E Lavanya |
| Designation |
associate professor |
| Affiliation |
srilakshmi narayana institute of medical sciences |
| Address |
department of anesthesiology
Pondicherry
PONDICHERRY
605006
India |
| Phone |
09629181969 |
| Fax |
|
| Email |
dr.lavanya08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
E Lavanya |
| Designation |
associate professor |
| Affiliation |
srilakshmi narayana institute of medical sciences |
| Address |
department of anesthesiology and critical care,
slims,puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
09629181969 |
| Fax |
|
| Email |
dr.lavanya08@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
E Lavanya |
| Designation |
associate professor |
| Affiliation |
srilakshmi narayana institute of medical sciences |
| Address |
department of anesthesiology
Pondicherry
PONDICHERRY
605006
India |
| Phone |
09629181969 |
| Fax |
|
| Email |
dr.lavanya08@gmail.com |
|
|
Source of Monetary or Material Support
|
| sri lakshmi narayana institute of medical sciences department of anesthesiology,osudu lake kudapakkam post,puducherry |
|
|
Primary Sponsor
|
| Name |
srilakshmi narayana institute of medical sciences |
| Address |
puducherry |
| 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 |
| elavanya |
srilakshmi narayana institute of medical sciences |
department of anesthesiology and critical care
Pondicherry
PONDICHERRY |
09629181969
dr.lavanya08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(human studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
asa 1 and 2 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
levobupivacaine and buprinorphine |
20 ml 0.25% levobupivacaine + 0.3 mg (1 ml) buprenorphine
2, 4, 6, 8, 10 12, 15, 18, 21, and 24 hr the pain rating was found by using NRS |
| Comparator Agent |
levobupivacaine with dexamethasone |
20 ml 0.25% levobupivacaine + 4 mg (1 ml) dexamethasone,
2, 4, 6, 8, 10 12, 15, 18, 21, and 24 h. If the pain rating was found to be NRS |
| Comparator Agent |
levobupivacaine with dexmedetomidine |
20 ml of levobupivacaine and 1ml of dexmedetomidine
2, 4, 6, 8, 10 12, 15, 18, 21, and 24 h. If the pain rating was found to be NRS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to participate in the study
ASA I &II.
Elective surgery under general anesthesia with endotracheal intubation cases
|
|
| ExclusionCriteria |
| Details |
ASA 3 or more
Patients with history of risk factors for perioperative aspiration of gastric contents,
history of chronic obstructive pulmonary disease, asthma,
history of recent respiratory infections,
duration of surgery more than 3 h were excluded from the study.
Pregnant and lactating mother
|
|
|
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 |
| The primary outcomes of the study were the time taken for the first analgesic dose |
2, 4, 6, 8, 10 12,
15, 18, 21, and 24 h. aftter tap block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| total rescue analgesic doses in the first 24 h, and the NRS score. |
24 hrs postoperatively |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/09/2022 |
| 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="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
yet to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Effect of addition of buprenorphine or dexamethasone
or dexmedetomidine to levobupivacaine on postoperative analgesia in ultrasound
guided transversus abdominis plane block in patients undergoing unilateral
inguinal hernia repair: a prospective randomized double blind controlled trial is the study. 90 patients aged between 18
to 70 years with the American Society of Anesthesiologists classification (ASA)
class 1 and 2 candidates for elective surgery under regional anesthesia at Sri
Lakshmi Narayana Institute Of Medical Sciences with Inclusion
criteria :Patients willing to participate in the study,ASA I &II,Patient age 18-70 years of either sex and Elective surgery under general anesthesia with
endotracheal intubation cases Exclusion
criteria : has ASA 3 or more,Patients with history of risk factors
for perioperative aspiration of gastric contents,history of chronic obstructive pulmonary
disease, asthma,history of recent respiratory
infections,duration of surgery more than 3 h were
excluded from the study, Pregnant and lactating mother and with study variables include General parameters i.e. Age, Gender, weight, height
and Duration of surgery and duration of
anesthesia.the time taken to request for the first analgesic,total
rescue analgesic doses in the first 24 h, and the NRS score(0 = no pain, 10 =
intolerable pain) just after the TAP block and at intervals of e at intervals of 0,2,4,6,8,10,12,15,18,21and 24
hrs postoperatively.Statistical analysis were performed using the
IBM Statistical Package for the Social Sciences (SPSS) for windows, version
22.0 (SPSS Inc., USA). Numerical data were analyzed by using an unpaired
Students t-test. Categorical data were analyzed by the chi square test or
Fisher’s exact test as appropriate. The differences among the 3 groups were
analyzed by using the one-way analysis of variance (ANOVA) test. |