| CTRI Number |
CTRI/2013/10/004042 [Registered on: 03/10/2013] Trial Registered Retrospectively |
| Last Modified On: |
19/09/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
effect of addition of clonidine to bupivacaine in transversus abdoninis plane block on postoperative pain after lower segment cesarean section |
|
Scientific Title of Study
|
a randomized controlled trial to evaluate the effect of addition of clonidine to bupivacaine in transversus abdoninis plane block on postoperative pain after lower segment cesarean section |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ranju Singh |
| Designation |
Professor, Anesthesia |
| Affiliation |
Lady Hardinge Medical College |
| Address |
B-2/532, Ekta Gardens,
I. P. Extension, Patparganj
Delhi
Shaheed Bhagat Singh Marg
New Delhi
DELHI
110092
India |
| Phone |
09811151285 |
| Fax |
|
| Email |
ranjusingh1503@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Snehlata Meena |
| Designation |
Post graduate student, Anesthesia |
| Affiliation |
Lady Hardinge Medical College |
| Address |
28, NSB Hostel,
Lady Hardinge Medical College,
Shaheed Bhagat Singh Marg
New Delhi
28, NSB Hostel,
Lady Hardinge Medical College,
Shaheed Bhagat Singh Marg
New Delhi
New Delhi
DELHI
110001
India |
| Phone |
|
| Fax |
|
| Email |
slmeena001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranju Singh |
| Designation |
Professor, Anesthesia |
| Affiliation |
Lady Hardinge Medical College |
| Address |
B-2/532, Ekta Gardens,
I. P. Extension, Patparganj
Delhi
Shaheed Bhagat Singh Marg
New Delhi
DELHI
110092
India |
| Phone |
09811151285 |
| Fax |
|
| Email |
ranjusingh1503@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical College and other Assosciated Hospitals |
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical College |
| Address |
Lady Hardinge Medical College
Shaheed Bhagat Singh Marg,
New Delhi,110001
110001 |
| Type of Sponsor |
Government 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 Ranju Singh Professor Anaesthesia |
Department of anaesthesia,Main OT complex, |
Department of Anaesthesia,
Shaheed Bhagat Singh Marg, Cannaught Place,New Delhi
Central
DELHI |
9811151285
ranjusingh1503@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| instituitonal ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Healthy Parturients coming for LSCS under spinal anesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
bupivacaine |
20 ml 0f 0.25% bupivacaine given as a single injection , once as TAP block, after LSCS in the operation theatre |
| Intervention |
clonidine 1µgkg-1 added to TAP block with bupivacaine |
clonidine 1µgkg-1, bilaterally, added to 20ml of 0.25% bupivacaine,
given once as a single injection,in TAP block,
following LSCS in the operation theatre |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
100 healthy parturients (ASA physical status I and II) carrying a singleton fetus at term, scheduled to undergo elective LSCS under spinal anaesthesia, followed by a TAP block to relieve postoperative pain |
|
| ExclusionCriteria |
| Details |
Patients who refused spinal anaesthesia, had any contraindication to regional anaesthesia, had any major co-morbidity or if they were unable to communicate in either English or Hindi language were excluded from this study. |
|
|
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 outcome will be the duration of postoperative analgesia, defined as the time (in hours) from the giving of the bilateral TAP block with clonidine 1µgkg-1 with 0.25% bupivacaine 20 ml bilaterally or 0.25% bupivacaine 20ml alone to the time to first analgesic request in the postoperative period. |
time (in hours) from the giving of the bilateral TAP block with clonidine 1µgkg-1 with 0.25% bupivacaine 20 ml bilaterally or 0.25% bupivacaine 20ml alone to the time when patient first demands analgesia in the postoperative period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•the total requirement of analgesics in the first 24hours postoperatively
•patients satisfaction and
•possible clonidine side effects (nausea and vomiting, sedation, dry mouth , hypotension & bradycardia) |
. after TAP block, observed every 30 minutes for the first 2 hours, then every hour for next 10 hours and thereafter every 2 hours till the patient demands first dose of analgesia. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2012 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Caesarean section is one of the most commonly performed surgical procedures. Most procedures are carried out under spinal anesthesia and patients typically receive spinal or systemic opioids or a combination of the two as a component of multimodal analgesia in the postoperative period. The analgesic regimen in these patients needs to meet the goal of providing safe, prolonged and effective analgesia with minimal side effects for the mother and her child. Therefore regional anesthesia techniques that reduce systemic analgesic requirement may be of benefit in this population. Transversus abdominis plane (TAP) block is a new, rapidly expanding regional anesthetic technique that blocks the abdominal wall neural afferents (T7 - L1) by introducing local anesthetic agent into this neurofascial plane. It is simple, efficacious and preserves bladder and lower limb motor function, thereby enabling early mobilization after surgery. TAP block is not associated with any hemodynamic instability unlike epidural anesthesia. Importantly, TAP block can be performed in sedated patients with no risk of neuraxial injury.
TAP block in caesarean section has been given with local anesthetic like bupivacaine and ropivacaine with limited duration of action. To the best of our knowledge there is yet no published literature regarding the use of additives like clonidine to bupivacaine in TAP block for caesarean section. Therefore the present study has been planned to investigate whether addition of 1.0 µgkg-1 clonidine to bupivacaine in TAP block increases the duration of postoperative analgesia in lower segment caesarean section or not as compared to plain bupivacaine.
HYPOTHESIS
Addition of clonidine to bupivacaine in TAP block increases the duration of postoperative analgesia in lower segment caesarean section, as compared to plain bupivacaine.
PRIMARY OBJECTIVE
To study the duration of postoperative analgesia with 1.0 µgkg-1 clonidine added to 20ml of 0.25% bupivacaine in bilateral TAP block for lower segment caesarean section and compare it with 20 ml of 0.25 % of plain bupivacaine
SECONDARY OBJECTIVES
To compare:
· the analgesic requirement in the first 24 hours postoperatively between the two groups.
· the difference in patient satisfaction scores between the three groups and
· side effects of clonidine.
METHODOLOGY- After the detailed pre-anesthetic check-up and investigations, written informed consent will be taken from the patient before their participation in the study (Annexure-II). Patients will be randomized to one of the two groups. Randomization will be done in the operating room prior to giving spinal anesthesia.
Group B (n=50) : TAP block with 20ml of 0.25% bupivacaine bilaterally
Group BC (n=50) : TAP block with 20ml of 0.25% bupivacaine + 0.5µgkg-1 clonidine bilaterally (total dose - 1.0 µgkg-1 )
Patients will receive a standard anesthetic comprising of hyperbaric 0.5% bupivacaine 1.8ml with 25µg fentanyl. TAP block will be performed under all asepsis, in the lumbar triangle of Petit bilaterally at the end of the surgical procedure and once the sensory block has receded to T10 level by pin prick. The TAP block will be performed by an investigator who has had an experience of giving at least 10 blocks prior to the investigation.The duration of postoperative analgesia, defined as the time (in hours) from the giving of the TAP block to the time to the first analgesic request in the postoperative period will be recorded. Degree of pain will be observed using the VAS every 30 minutes for the first 2 hours, then every hour for next 10 hours and thereafter every 2 hours till the patient demands first dose of analgesia. VAS score at the time of first analgesic request will be recorded. Patients will be given inj. diclofenac 1mg/kg IV (to a maximum of 3mg/kg/day) on demand or if the VAS score is ≥3. Sedation will be evaluated using a four point ordinal scale. A modified four point patient satisfaction score will also be noted. Other associated side effects will be observed.
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