| CTRI Number |
CTRI/2019/09/021391 [Registered on: 24/09/2019] Trial Registered Prospectively |
| Last Modified On: |
24/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Study of Effectiveness of Ultrasound Guided Posterior Transversus Abdominis Plane(TAP) Block Vs Epidural Analgesia For Postoperative Pain Relief in Lower Abdominal Surgeries. |
|
Scientific Title of Study
|
A Comparative Study of Effectiveness of Ultrasound Guided Transversus Abdominis Plane(TAP) Block Vs Epidural Analgesia For Postoperative Pain Relief in Lower Abdominal Surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Santosh Bhagasara |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. S. N. Medical College, Jodhpur |
| Address |
Department Of Anaesthesiology and Critical Care,
Dr. S. N. Medical College, Jodhpur.
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9414112844 |
| Fax |
|
| Email |
drsantoshbhagasara@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelam Meena |
| Designation |
Associate Professor |
| Affiliation |
Dr. S. N. Medical College, Jodhpur |
| Address |
Department Of Anaesthesiology and Critical Care,
Dr. S. N. Medical College, Jodhpur.
Jodhpur
RAJASTHAN
342003
India |
| Phone |
8302537601 |
| Fax |
|
| Email |
drneelamsiddhimeena@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhilasha Thanvi |
| Designation |
Assistant Professor |
| Affiliation |
Dr. S. N. Medical College, Jodhpur |
| Address |
Department Of Anaesthesiology and Critical Care,
Dr. S. N. Medical College, Jodhpur.
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9799855177 |
| Fax |
|
| Email |
abhilashathanvi@ymail.com |
|
|
Source of Monetary or Material Support
|
| DR. S.N. MEDICAL COLLEGE, JODHPUR |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| Santosh Bhagasara |
Mahatma Gandhi Hospital/Mathura Das Mathur Hospital |
Main OT, New Gyne in MDM Hospital, Main OT in MGH
Jodhpur
RAJASTHAN |
9414112844
drsantoshbhagasara@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. SNMC Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N400||Benign prostatic hyperplasia without lower urinary tract symptoms, (2) ICD-10 Condition: K400||Bilateral inguinal hernia, with obstruction, without gangrene, (3) ICD-10 Condition: N813||Complete uterovaginal prolapse, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GROUP A |
GROUP A patients will be positioned supine. After skin closure, under strict asepsis and under USG guidance 20 ml 0.2% Ropivacaine will be injected with 22 G Quincke’s needle on each side of the abdominal wall in the plane between transversus abdominis and internal oblique muscles after hydro dissection with 0.9 % saline (2-5 ml). |
| Comparator Agent |
GROUP B |
GROUP B patients will be positioned in lateral decubitus or sitting position and under strict asepsis lumbar epidural catheter will be placed at vertebral levels (as clinically indicated). After injection of a test dose of 2ml of 2 % Lignocaine with 1:200,000 epinephrine, the patient will be induced and the surgery continued.10 ml of 0.2% Ropivacaine will be administered at skin closure. |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA GRADE I, II,
Weight 50kg to 90kg,
Elective Lower Abdominal Surgeries, |
|
| ExclusionCriteria |
| Details |
Patient refusal.
Patients ASA grade III ,IV
Age >80 years
Patients on chronic opioid usage
Patients with allergies to local anaesthetics
Patients with significant coexisting diseases like ischemic heart disease, hypertension, cardiovascular diseases, impaired renal functions and severe liver disease.
Any existence of contraindications to regional anaesthesia in the presence of anti-platelet, anticoagulant drug use, bleeding/clotting disorders.
Evidence of any neurological impairment.
Cases with failed blocks.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) TO COMPARE THE QUALITY OF ANALGESIA AND DURATION OF ANALGESIA.
2) TOTAL OPIOID CONSUMPTION IN FIRST TWENTY FOUR HOURS. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) TO COMPARE THE EFFECT OF TAP BLOCK ON HEMODYNAMIC PARAMETERS AND OTHER VITAL PARAMETERS IN TERMS OF HEART RATE, BLOOD PRESSURE, OXYGEN SATURATION(SPO2) AND RESPIRATORY RATE.
2) POSTOPERATIVE COMPLICATIONS INCLUDING LOCAL ANESTHETIC TOXICITY,POSTOPERATIVE NAUSEA AND VOMITING,HEMODYNAMIC INSTABILITY, HEMATOMA AT THE SITE OF INJECTION ETC.
3) PATIENT’S SATISFACTION |
24 hours |
|
|
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)
|
29/09/2019 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
70 PATIENTS OF AGE 18 TO 80 YEARS OF BOTH SEXES UNDERGOING LOWER ABDOMINAL SURGERY WILL RANDOMLY ASSIGNED INTO TWO GROUPS (GROUP A & GROUP B) FOR POSTOPERATIVE ANALGESIA USING ULTRASONOGRAPHY GUIDED POSTERIOR TRANSVERSUS ABDOMINS PLANE BLOCK AND EPIDURAL BLOCK .EACH GROUP HAVING EQUAL NUMBER OF PATIENTS. RANDOMIZATION WILL BE DONE BY A COMPUTER GENERATED RANDOMIZATION. PATIENTS OF GROUP A WILL BE GIVEN TAP BLOCK WITH ROPIVACAINE AND PATIENTS OF GROUP B WILL BE GIVEN EPIDURAL BLOCK WITH ROPIVACAINE.
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