| CTRI Number |
CTRI/2018/01/011163 [Registered on: 05/01/2018] Trial Registered Prospectively |
| Last Modified On: |
04/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of abdominal block for postoperative pain relief after total abdominal hysterectomy. |
|
Scientific Title of Study
|
Evaluation of Efficacy of Ultrasound Guided Transversus Abdominis Plane Block in Multimodal Regimen for Postoperative Analgesia after Total Abdominal Hysterectomy done under Combined Spinal Epidural Anaesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Motaka Mayurkumar |
| Designation |
DNB trainee |
| Affiliation |
Tata Motors Hospital |
| Address |
Department of Anaesthesiology
Tata Motors Hospital,
Telco colony, Near Kharangajar,Jamshedpur.
Purbi Singhbhum
JHARKHAND
831004
India |
| Phone |
8092612434 |
| Fax |
|
| Email |
mayur71039@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SS Parida |
| Designation |
Chief Consultant |
| Affiliation |
Tata Motors Hospital |
| Address |
Department of Anaesthesiology, Tata Motors Hospital, Telco colony, Near Kharangajar, Jamshedpur.
Purbi Singhbhum
JHARKHAND
831004
India |
| Phone |
9234500701 |
| Fax |
|
| Email |
ssparida@tatamotors.com |
|
Details of Contact Person
Public Query
|
| Name |
Motaka Mayurkumar |
| Designation |
DNB trainee |
| Affiliation |
Tata Motors Hospital |
| Address |
Department of Anaesthesiology, Tata Motors Hospital, Telco colony, Near Kharangajar, Jamshedpur.
Purbi Singhbhum
JHARKHAND
831004
India |
| Phone |
8092612434 |
| Fax |
|
| Email |
mayur71039@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Motors Hospital |
| Address |
Telco colony,
Near Kharangajar,
Jamshedpur. |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Motaka Mayurkumar |
Tata Motors Hospital |
OT complex, Department of Anaesthesiology,
Telco colony,
Near Kharangajar,
Jamshedpur
Purbi Singhbhum
JHARKHAND |
8092612434
mayur71039@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TataMotorsMedical |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Postoperative pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No TAP Block |
Postoperative standard analgesic treatment consist of routine 75 mg diclophenac doses and epidural 3 ml drug (Bupivacaine 0.125% + Morphine 2.4 mg) will be given. |
| Intervention |
Ultrasound guided Transversus Abdominis Plane (TAP) Block |
Ultrasound guided TAP block will be given at end of surgery using 0.375% ropivacaine 20 ml on both sides apart from Postoperative standard analgesic treatment consist of routine 75 mg diclophenac doses and epidural 3 ml drug (Bupivacaine 0.125% + Morphine 2.4 mg) will be given. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
All patients undergoing total abdominal hysterectomy under combined spinal epidural anaesthesia after obtaining informed consent.
ASA grade I-III.
Total abdominal hysterectomy performed via lower abdominal transverse (Pfannenstiel) incision. |
|
| ExclusionCriteria |
| Details |
Patient refusal.
A history of drug allergy or local anaesthetic toxicity.
BMI >35kg/m2 (to limit maximum Ropivacaine dose to 3mg/kg)
Contraindications to regional anaesthesia (bleeding diathesis, infection at the site of block and peripheral neuropathy)
Change of anaesthetic technique to general anaesthesia.
Failure or complication in epidural catheter insertion.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia |
0,2,4,6,8,10,12,18 and 24 hr. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Epidural morphine consumption.
Severity of pain.
Incidence / severity of nausea-vomiting, pruritus, sedation and respiratory depression.
Complications of TAP block.
Adverse effects of local anaesthetics.
Patient satisfaction.
|
0,2,4,6,8,10,12,18 and 24 hr. |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
15/01/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, double blind, parallel group, evaluating efficacy of Ultrasound guided Transversus Abdominis Plane (TAP) block in multimodal regimen after total abdominal hysterectomy patients done under combined spinal epidural aneasthesia technique in India. Subjects randomized in to two groups, Control group will receive standard postoperative analgesic treatment while study group will receive standard postoperative analgesic treatment and TAP block. The primary outcome measure will be assessment of duration of analgesia postoperatively within 24 hours. Secondary outcomes will be epidural morphine consumption, pain severity using visual analogue scores, Incidence of nausea-vomiting, pruritus, sedation and respiratory depression, complication of TAP block, Adverse effect of drug and patient satisfaction at 0, 2, 4, 6, 8, 10, 12, 18 and 24 hours.
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