| CTRI Number |
CTRI/2016/12/007544 [Registered on: 07/12/2016] Trial Registered Retrospectively |
| Last Modified On: |
21/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Other (Specify) [pain relief] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
to study intraperitoneal use of clonidine(alpha agonist), as additive to local anaesthetic) for postoperative pain relief and sideeffects after abdominal uterus removal |
|
Scientific Title of Study
|
Postoperative analgesic effect of intravenous (i.v.) clonidine compared with clonidine administration in wound infiltration for total abdominal hysterectomy – a randomized control study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Gupta |
| Designation |
DNB student |
| Affiliation |
Mata Chanan Devi Hospital |
| Address |
C-1 block
Janakpuri
West
DELHI
110058
India |
| Phone |
9990925895 |
| Fax |
|
| Email |
darydivs@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramod Mangwana |
| Designation |
Head of Department and Senior consultant |
| Affiliation |
Mata Chanan Devi Hospital |
| Address |
G- 17
Pocket 2
behind Saraswati balmandir
Naraina Vihar
C-1 block
Janakpuri
Delhi 110058
West
DELHI
110028
India |
| Phone |
9810956411 |
| Fax |
|
| Email |
drpmangwana@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya Gupta |
| Designation |
DNB student |
| Affiliation |
Mata Chanan Devi Hospital |
| Address |
C-1 block
Janakpuri
West
DELHI
110058
India |
| Phone |
9990925895 |
| Fax |
|
| Email |
darydivs@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Mata Chanan Devi Hospital |
|
|
Primary Sponsor
|
| Name |
Mata Chanan Devi Hospital |
| Address |
C-1 block, Janakpuri
Delhi 110058 |
| Type of Sponsor |
Other [charitable trust] |
|
|
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 Divya Gupta |
Mata Chanan Devi Hospital |
Operation theatre
2nd floor
C-1 block,Janakpuri
West
DELHI |
9990925895
darydivs@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mata Chanan Devi Hospital Ethical Committee |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
ASA I & II patients aged 35 to 60 yrs for elective total abdominal hysterectomy after ruling out use of adrenoreceptor agonists,antagonists or narcotics before surgery, hypersensitivity to study drug., (1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
intraperitoneal Clonidine |
Clonidine given intraperitonealy at the dose of 3mcq/kg along with 30 ml of 0.25% Bupivicaine before peritoneal closure |
| Comparator Agent |
intravenous clonidine |
clonidine given intravenously at the time of peritoneum closure at the dose of 3mcq/kg along with 0.25% bupivicaine 30 ml(total volume) intraperitoneal as well as skin insition site |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
•60 ASA grade I and II female patients
•Age between 35 to 60 years
•scheduled for elective total abdominal hysterectomy surgery under general anaesthesia.
•Patient willing to give written informed consent for participation in the study.
|
|
| ExclusionCriteria |
| Details |
1) Patients with – ASA grade 3 or above.
2) Age more than 60 yrs or less than 35 yrs. 3) Patients with morbid obesity, Raynaud’s disease.
4) Patients receiving adrenoreceptor agonists,antagonists, or narcotics before operation.
5) Patient’s refusal to participate in the study.
6) Known hypersensitivity to the study drug
7) H/o cardiovascular, respiratory, hepatic, renal, neurological or endocrine disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the analgesic efficacy of clonidine in wound infiltration with bupivacaine and to compare the same with Intravenous administration in terms of postoperative analgesic requirement and side-effects (nausea, sedation, bradycardia and hypotension) |
for heart rate and blood pressure- at peritoneal closure, 15,30,45,60,90,120 minutes after it.
for pain,sedation,nausea- at post anaesthesia care unit arrival,2,4,6,12,24hours after it |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time of opioid requirement |
noted for first 24 hours postoperatively. |
| Dose of opioid needed |
over first 24 hours. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/08/2014 |
| 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="1"
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
|
Our objective in this study was to assess the analgesic efficacy and side effects of intraperitoneal clonidine. 60 females were randomly divided into 2 groups. Group I- patients received 3mcq/kg clonidine intravenously at the time of peritoneal closure along with 30ml of 0.25% bupivacaine intraperitoneally as well as at skin incision site. Group II- patients received both 3mcq/kg clonidine and 30 ml of 0.25% bupivacaine intraperitoneally and at skin incision site. Pain scores as well as heart rate, blood pressure, nausea and sedation scores were noted at predetermined intervals. Breakthrough pain was treated with fentanyl i.v. and total opioid dose required was noted. It was hypothesised that the analgesic efficacy and side efffects of intraperitoneal clonidine are similar to intravenous clonidine. |