CTRI Number |
CTRI/2015/05/005803 [Registered on: 22/05/2015] Trial Registered Retrospectively |
Last Modified On: |
22/05/2015 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparision of ANALGESIC EFFECACY OF ULTRASOUND GUIDED ABDOMINAL BLOCK WITH EPIDURAL ANALGESIA IN PATIENTS UNDERGOING LOWER ABDOMINAL GYNAECOLOGICAL PROCEDURES |
Scientific Title of Study
|
RANDOMISED CONTROL TRIAL TO COMPARE THE ANALGESIC EFFECT OF ULTRASOUND GUIDED TRANSVERSUS ABDOMINUS PLANE BLOCK WITH EPIDURAL ANALGESIA IN PATIENTS UNDERGOING LOWER ABDOMINAL GYNAECOLOGICAL PROCEDURES |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Jeetinder Makkar |
Designation |
Assistant Professor |
Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH, INDIA |
Address |
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE, PGIMER, SECTOR 12 CHANDIGARH DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE
PGIMER, sector 12,CHANDIGARH
Chandigarh CHANDIGARH 160047 India |
Phone |
|
Fax |
|
Email |
jeet1516@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Jeetinder Makkar |
Designation |
Assistant Professor |
Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH, INDIA |
Address |
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE, PGIMER, SECTOR 12, CHANDIGARH DEPARTMENT OFANAESTHESIA AND INTENSIVE CARE
PGIMER, CHANDIGARH
Chandigarh CHANDIGARH 160047 India |
Phone |
9914209510 |
Fax |
|
Email |
jeet1516@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Jeetinder Makkar |
Designation |
Assistant Professor |
Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH, INDIA |
Address |
TF14, PGIMER, Sector 12 DEPARTMENT OFANAESTHESIA AND INTENSIVE CARE
PGIMER, CHANDIGARH
CHANDIGARH 160047 India |
Phone |
|
Fax |
|
Email |
jeet1516@gmail.com |
|
Source of Monetary or Material Support
|
post graduate institute of medical education & research, Chandigarh |
|
Primary Sponsor
|
Name |
Post Graduate Institue of Medical education research |
Address |
PGIMER, SECTOR 12, CHANDIGARH |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
Name |
Address |
AJAY PADMANABANR |
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE
PGIMER
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Ajay |
Post graduate institute of medical education and research |
Department of Anesthesia, 4th Floor, Nehru Hospital Chandigarh CHANDIGARH |
7087009510
nscjk2006@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institute ethics committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
patients undergoing lower abdominal gynecological surgeries, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Control group |
Patients will receive TAP block with 20ml of 0.9% normal saline |
Intervention |
Group TAP |
Ultrasound guided TAP block with 20 ml of bupivacaine 0.25% on both sides after aspiration. |
|
Inclusion Criteria
|
Age From |
35.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Female |
Details |
ASA class I or II undergoing elective total abdominal hysterectomies |
|
ExclusionCriteria |
Details |
Contraindications to epidural anesthesia (coagulopathy, local infection),History of relevant drug allergy, Uncooperative patient, Patients with BMI > 35,History of chronic pain, History of previous surgery
|
|
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 |
to determine the effect of transversus abdominis plane block on the quality of postoperative analgesia as assessed using visual analogue scores (VAS) both at movement (coughing) and at rest |
to determine the effect of transversus abdominis plane block on the quality of postoperative analgesia as assessed using visual analogue scores (VAS) both at movement (coughing) and at rest immediately in the post operative period and then at 30min, 1,2, 4,6,12,24,and 48hrs. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Bedside pulmonary function tests using Wrights respirometer
|
2, 4, 12, 24 hours |
Total epidural local anaesthetic consumption in the 1st 48 hours postoperatively. |
upto 48 hrs |
|
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
|
Phase 4 |
Date of First Enrollment (India)
|
30/03/2012 |
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="5" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Total
abdominal hysterectomy is a routinely performed major surgery that results in
substantial post-operative pain and discomfort.
Poorly controlled acute pain after abdominal hysterectomy is associated
with increased incidence of post-operative complications like atelectasis,
pneumonia, delirium, myocardial ischemia, prolonged hospital stay and an
increased likelihood of chronic pain. For
postoperative pain relief, non-opioid drugs, patient controlled intravenous
strong opioids or central neuroaxial blockade are introduced in a stepwise
fashion in response to reported pain intensity, usually combining two or more
agents to provide adequate relief whilst minimizing adverse effects from any
individual analgesic. Peripheral nerve blockade is an alternative method of
providing pain relief, which offers excellent selective analgesia across a wide
range of surgical procedures. Epidural
analgesia is the gold standard analgesic technique. It is associated with lower
visual analogue pain scores (VAS) and higher patient satisfaction. However undesirable effects like motor blockade and
urinary retention with increasing doses of local anaesthetics have been
reported. A failure rate ranging from 17-37% has also been reported with the
use of this technique. Opioids delivered using
patient controlled analgesia is another modality available. Though patients may
be comfortable at rest, some may experience significant pain on movement.
Adverse effects like sedation, nausea, vomiting, pruritis and respiratory
depression are frequently associated with this technique. Renal toxicity, general bleeding risks are associated with use of non
opioids like non steroidal anti-inflammatory drugs.
Abdominal
wall incision contributes to a significant component of pain experienced by
patients after abdominal surgery. A promising
novel approach to post-operative analgesia is to block the sensory nerve supply
to the anterior abdominal wall using transversus abdominis plane block. TAP
block involves infiltration of local anaesthetic into a plane between the
internal oblique and transverse abdominis muscle, thus blocking the sensory
nerves before their infiltration of the muscles of anterior abdominal wall.The
analgesic efficacy of TAP block has been demonstrated in different surgical
procedures. However, the analgesic efficacy of
sonographically guided TAP block has not been compared with epidural analgesia
previously.
We
hypothesize that co-administration of sonographically guided TAP block with continuous epidural infusion of local
anesthetics as part of a multimodal analgesic technique would result in
superior postoperative analgesia (lower pain scores) and better patient
satisfaction following total abdominal hysterectomy. |