| CTRI Number |
CTRI/2020/01/022973 [Registered on: 27/01/2020] Trial Registered Prospectively |
| Last Modified On: |
03/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of pain relief in the postoperative period with Continuous epidural infusion and Patient controlled epidural device for patients undergoing major abdominal oncologic surgeries |
|
Scientific Title of Study
|
Comparison of patient controlled epidural analgesia (PCEA) with continuous epidural analgesia (CEA) for postoperative pain management after major abdominal oncologic surgeries :A Prospective Randomised Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ROSY JACOB |
| Designation |
Junior Resident |
| Affiliation |
St. Johns Medical College |
| Address |
Department of Anaesthesiology, St. Johns Medical College, Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
7829316825 |
| Fax |
|
| Email |
rosyjeevanjacob@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bindu George |
| Designation |
Professor and HOD |
| Affiliation |
St. Johns Medical College |
| Address |
Department of Anaesthesiology, St. Johns Medical College, Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9342552324 |
| Fax |
|
| Email |
bindu575@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ROSY JACOB |
| Designation |
Junior Resident |
| Affiliation |
St. Johns Medical College |
| Address |
Department of Anaesthesiology, St. Johns Medical College, Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
7829316825 |
| Fax |
|
| Email |
rosyjeevanjacob@gmail.com |
|
|
Source of Monetary or Material Support
|
| St. Johns Medical College |
|
|
Primary Sponsor
|
| Name |
St Johns Medical College |
| Address |
Bangalore, Karnataka 560034 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Rosy Jacob |
St. Johns Medical College Hospital |
Department of Anesthesiology, St. Johns National Academy of Health Sciences,Bangalore , Karnataka 560034
Bangalore
KARNATAKA |
7829316825
rosyjeevanjacob@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, St. Johns Medical College and Hospital,Sarjapur Road,, Bangalore 560034 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, (2) ICD-10 Condition: C55||Malignant neoplasm of uterus, partunspecified, (3) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, (4) ICD-10 Condition: C19||Malignant neoplasm of rectosigmoidjunction, (5) ICD-10 Condition: C20||Malignant neoplasm of rectum, (6) ICD-10 Condition: C259||Malignant neoplasm of pancreas, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Continuous Epidural Analgesia |
Epidural infusion of 5-6ml with 0.125% Bupivacaine plus 2 mcg fentanyl will be administered intraoperatively using a B Braun Perfusor Compact,USA, will be maintained for patients for the 48 hours at rate of 5-6ml/hr with increments of 1-1.5ml if patient complains of pain. |
| Intervention |
Patient Controlled Epidural Analgesia |
Epidural catheter will be connected to a Patient Controlled Analgesia (PCA) device (B Bruan Spacer Perfusion, USA) ,All patients will be maintained on a background infusion of 4ml/hr and will be allowed to inject themselves with a bolus of 2ml of 0.125% Bupivacaine plus 2 mcg Fentanyl,Lockout interval will be set at 20 minutes. Maximum dose of epidural will be 6ml in one hour. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Patients above age of 18 years to 59 years belonging to ASA I, II, III undergoing major abdominal oncologic surgery in St. John’s Medical College Hospital during the study period. |
|
| ExclusionCriteria |
| Details |
Patients who have a clinical or laboratory contraindication to the placement of an epidural catheter like bleeding diathesis, severe hypovolemia, elevated intracranial pressure (particularly with an intracranial mass), severe aortic stenosis, severe mitral stenosis and infection at the site of injection.
Inability to use the PCEA device
Patient posted for Gastrectomy.
Patients who have a known allergy to the local anaesthetic or opioid used
Patient refusal
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of PCEA and CEA in post op pain management in terms of
a) VAS scores measured hourly for 48 hours.
b) Requirement of rescue analgesia
c) Cumulative dose of local anaesthetic at the end of 48 hours.
|
To compare the efficacy of PCEA and CEA in post op pain management in terms of
a) VAS scores measured hourly for 48 hours.
b) Requirement of rescue analgesia
c) Cumulative dose of local anaesthetic at the end of 48 hours.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) To compare patient satisfaction in PCEA with CEA in the postoperative period
b) To compare the incidence of side effects (Hypotension, Motor Weakness, Numbness. Nausea and Vomiting, Sedation, Pruritus, Respiratory depression, Postoperative ileus)
|
At the end of 48 hours |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
31/01/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Objective of the is to compare the postoperative pain
relief provided by two different modalities-Patient Controlled Epidural
Analgesia (PCEA) and Continuous Epidural Analgesia (CEA) in patients undergoing
major abdominal oncologic surgeries.
Studies comparing PCEA with CEA have often been
retrospective in design. The non-randomised nature of these studies resulted in
an uneven distribution between the groups and possible bias- the effect of the
PCEA may be due to the psychological factor of ‘self-control’ resulting in less
complaints, nurses may call pain service earlier in case of CEA, or delay
because of the hassle involved in a top up dose. Hence validation through a
prospective randomised controlled trial is required.
Many hospitals and anaesthesiologists continue using
CEA for reasons of simplicity, scarcity of PCA pumps and intricacy of handling
these pumps. In our institution, CEA is the standard of care. Supervision and
monitoring of CEA given the logistics of a large hospital and teaching centre
with regards to response time, time to contact a physician to do a top up and
assessment of side effects and dosage of drug consumed is difficult. PCEA if
established as a standard of care, can reduce the requirement for top ups,
incidence of side effects and overall dose of local anaesthetic and/or opioid.
Identification of an effective postoperative
analgesic modality in patients undergoing major abdominal oncologic surgeries
can in turn be useful in prescribing pain relief in patients undergoing
gynaecologic, genitourinary, orthopaedic and thoracic surgeries.
Identification of a safe, practical and effective
pain relief method can help in early recovery after surgery and anaesthesia,
prevent pharmacological side effects, lead to early ambulation of the patient
and fulfilment of discharge criteria. |