| CTRI Number |
CTRI/2018/12/016782 [Registered on: 26/12/2018] Trial Registered Prospectively |
| Last Modified On: |
22/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Regional block vs Analgesics for post operative pain relief in abdominal hysterectomy. |
|
Scientific Title of Study
|
Study of effect of transversus abdominis plane block for post operative analgesia in abdominal hysterectomy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chidanand Nazirkar |
| Designation |
2nd year Resident in MD Anaesthesia |
| Affiliation |
MGM Hospital,Aurangabad |
| Address |
Resident hostel,room no 6, MGM Medical college and Hospital,N6,CIDCO,Aurangabad
MGM Hospital,N6,CIDCO,Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9503720889 |
| Fax |
|
| Email |
cnazirkar01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramod Bhale |
| Designation |
Professor of Anaesthesia,Dept of Anaesthesia,MGM Aurangabad |
| Affiliation |
MGM Hospital,Aurangabad |
| Address |
Plot no 2,Ekta housing society,Near Mayur park road, opp Krishna mangal karyalay,Harsul area,Aurangabad
Dept of Anaesthesia, MGM Medical college and Hospital, N6,cidco,Aurangabad
Aurangabad
MAHARASHTRA
431008
India |
| Phone |
8888819021 |
| Fax |
|
| Email |
Pramod.bhale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chidanand Nazirkar |
| Designation |
Resident in MD Anaesthesia |
| Affiliation |
MGM Hospital,Aurangabad |
| Address |
Residents hostel, room no 6, 3rd floor,MGM medical college and Hospital, N6,cidco,Aurangabad
MGM Hospital,N6,cidco,Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9503720889 |
| Fax |
|
| Email |
cnazirkar01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Chidanand Nazirkar Resident, dept of Anaesthesia, Resident hostel, room no 6,3rd floor, MGM Medical college and Hospital, Aurangabad |
|
|
Primary Sponsor
|
| Name |
Dr Chidanand Nazirkar |
| Address |
Room no 6,Resident hostel,3rd floor,
MGM Hospital,
N6,CIDCO,Aurangabad,MH |
| Type of Sponsor |
Other [Self] |
|
|
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 Chidanand Nazirkar |
MGM Hospital |
Department of Anaesthesia,OT complex,Aurangabad,431003
Aurangabad
MAHARASHTRA |
9503720889
cnazirkar01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM Ethics Committee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, (2) ICD-10 Condition: N859||Noninflammatory disorder of uterus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine Analgesic methods post hysterectomy |
Group N patients will receive Inj Diclofenac 75 mg i.v. in 100 ml NS after skin closure |
| Intervention |
Study of effect of addition of dexamethasone to transversus abdominis plane block for post operative analgesia in abdominal hysterectomy |
Study of effect of addition of dexamethasone to transversus abdominis plane block for post operative analgesia in abdominal hysterectomy |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
ASA grade 1 or 2
Under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
Patient not willing
Allergy to Ropivacaine
Compromised renal and liver function
Uncontrolled DM
Severe CVS or Respiratory disease
Coagulation disorder
BMI more than 35 |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the degree of analgesia achieved by TAP block |
24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess duration of post operative analgesia
To assess requirement of rescue analgesics after TAP block within 24 hrs
|
24 hrs |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
27/12/2018 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Total abdominal hysterectomy(TAH) is
commonly performed major surgical procedure. It results in substantial post
operative pain and discomfort. These patients require multimodal post operative
pain treatment regimen.
Inadequate control of
post operative pain leads to unwanted side effects like discomfort, thromboembolic phenomenon and
pulmonary complications
Conventional methods like use of NSAIDS
although provide satisfactory
analgesia are associated with unwanted side effects like gastric irritation,bleeding. Epidural analgesia is
used to reduce pain after surgeries, but it might be contra indicated in some patients. TAP
block is novel type of truncal nerve block that
involves innervation of anterolateral abdominal wall derived from T6 to L1. It provides adequate
post operative pain relief following various abdominal surgeries. Advantages of
TAP block includes preservation of lower limb motor function,hemodynamic stability and less invasiveness. This
prospective randomised control double blind study is designed to test the
hypothesis that TAP block with dexamethasone will provide effective analgesia
after TAH in comparison to
use of conventional methods like NSAIDS. |