| CTRI Number |
CTRI/2017/05/008654 [Registered on: 25/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
08/06/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to find out if giving pain medication through small tubes placed under lower belly muscle is as good as giving pain medicine through tube placed in the lower back after belly operation . |
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Scientific Title of Study
|
Comparison of Analgesic Efficacy of Continuous Bilateral Transversus Abdominis Plane Catheter Infusion with that of Lumbar Epidural for Post Operative Analgesia in patients undergoing Lower Abdominal Surgeries |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Srinivasan Swaminathan |
| Designation |
Assistant Professor |
| Affiliation |
JIPMER |
| Address |
Department of Anesthesiology and critical care, JIPMER, Puducherry-605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
91-9626493045 |
| Fax |
|
| Email |
srinidnb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srinivasan Swaminathan |
| Designation |
Assistant Professor |
| Affiliation |
JIPMER |
| Address |
Department of Anesthesiology and critical care, JIPMER, Puducherry-605006
PONDICHERRY
605006
India |
| Phone |
91-9626493045 |
| Fax |
|
| Email |
srinidnb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sabina Regmi |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department of Anesthesiology and critical care, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry
Room no 117, Blackwell 2, Hostel Complex, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry-605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
91-9786974607 |
| Fax |
|
| Email |
sappu.r@gmail.com |
|
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Source of Monetary or Material Support
|
| Intramural Fund, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri Nagar, Gorimedu, puducherry 605006 |
|
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Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Dhanvantri Nagar, Gorimedu, puducherry 605006 |
| Type of Sponsor |
Research institution and hospital |
|
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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 |
| Dr Srinivasan Swaminathan |
JIPMER hospital |
Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER),Dhanvantri
Nagar, Puducherry,605006.
Pondicherry
PONDICHERRY |
9626493045
srinidnb@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
All ASA 1 and 2 patients of age 18-70 years posted for lower abdominal surgeries with incision at or below the level of umbilicus
, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Insertion of B/l transversus abdominis plane (TAP) catheter |
The skin will be prepared with 2% chlorhexidine solution. An ultrasound probe will be placed in the anterior abdominal wall. After identification of the fascial plane between the internal oblique and the transversus abdominis muscle, a 16 gauge TAP needle will be inserted anteriorly in the plane of ultrasound beam and directed towards the transversus abdominis plane. On entering the fascial plane, 10 ml of normal saline 0.9% will be used to open up the potential space (hydrodissection). The injectate can be observed spreading in the tranversus abdominis plane as a dark oval shape. TAP catheter will then be threaded into the TA plane. Both the catheters will then be attached to an infusion pump |
| Comparator Agent |
Insertion of lumbar epidural catheter |
Under standard aseptic conditions lumbar epidural catheter will be inserted. Position confirmed with administration of test dose lignocine 45mg with 1:2,00,000 adrenaline. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 patients posted for lower abdominal surgeries with incision at and below the level of umbilicus |
|
| ExclusionCriteria |
| Details |
Contraindications to regional anaesthesia (coagulopathy and patient refusal), Renal or hepatic derangement, Known hypersensitivity to drugs used, Pregnancy, Abdominal wall abscess,Obese patients (BMI > 35)
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Visual analogue score at rest and on coughing |
1,4,8,12 and 24 hrs after surgery |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Rescue morphine dose requirement |
During the period of 24 hrs after surgery |
| Sensory dermatome block by pin prick and cold perception |
1,4,8,12,24 hours |
| Incidence of hypotension taken as systolic fall in BP of more than 20% of baseline value |
During the period of 24 hrs after surgery |
| Post operative nausea and vomiting |
During 24 hrs after surgery |
| Patients satisfaction scale using Likerts scale |
At the end of 24 hrs |
|
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Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
03/12/2015 |
| 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="2"
Months="6"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Neuraxial blockade is associated with higher degree of complications. If same analgesic efficacy can be achieved with TAP block catheters, then with enough evidence it can be included in a post operative pain management protocol. Also single shot local anaesthetic post operatively have shown to act for 6-8 hours. Using a continuous infusion would be more rational for prolonged post operative analgesia.We are expecting that TAP infusion has comparable analgesic efficacy to continuous epidural infusion. Thus in the future TAP catheter infusions can be included in multi model post operative analgesia in place of epidural once enough evidence is available. Our research hypothesis is continuous bilateral Transversus Abdominis Plane (TAP) catheter infusion is as efficacious as continuous lumbar epidural infusion in post operative pain management.
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