| CTRI Number |
CTRI/2024/07/070242 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study comparing two routes for giving two classes of drugs by comparing postoperative quality of recovery using a 15 point questionnaire after cancer surgeries of abdomen under general anaesthesia. |
|
Scientific Title of Study
|
Quality of Recovery (q0R 15) following administration of intravenous vs epidural opioids and non opioids in oncological abdominal surgeries under GA. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arpita Thombre |
| Designation |
PG Resident 2nd year |
| Affiliation |
Pt JNM Medical College |
| Address |
Department of anaesthesiology and pain medicine, Pt JNM Medical College, Raipur, C.G.
Raipur
CHHATTISGARH
492001
India |
| Phone |
8839671949 |
| Fax |
|
| Email |
arpi.thombre@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratibha Jain Shah |
| Designation |
HOD and professor |
| Affiliation |
Pt JNM Medical College, Raipur, C.G. |
| Address |
Department of anaesthesiology and pain medicine, Pt JNM Medical College, Raipur, C.G.
Raipur
CHHATTISGARH
492001
India |
| Phone |
9827276620 |
| Fax |
|
| Email |
prati_jain@redifffmaail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arpita Thombre |
| Designation |
PG Resident 2nd year |
| Affiliation |
Pt JNM Medical College, Raipur, C.G. |
| Address |
Department of anaesthesiology and pain medicine, Pt JNM Medical College, Raipur, C.G.
Raipur
CHHATTISGARH
492001
India |
| Phone |
8839671949 |
| Fax |
|
| Email |
arpi.thombre@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Anaesthesiology and Pain Medicine Pt JNM Medical College, Raipur, C.G.,India 492001 |
|
|
Primary Sponsor
|
| Name |
Arpita Thombre |
| Address |
Department of anaesthesiology and pain medicine, Pt JNM Medical college, Raipur, C.G., India, 492001 |
| 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 Arpita Thombre |
Dr Bhim Rao Ambedkar Memorial Hospital |
Dept of anaesthesiology and pain medicine Pt JNM Medical college, Raipur, C.G.
Raipur
CHHATTISGARH |
8839671949
arpi.thombre@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE PT JNM MEDICAL COLLEGE, RAIPUR C.G. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C179||Malignant neoplasm of small intestine, unspecified, (2) ICD-10 Condition: C55||Malignant neoplasm of uterus, partunspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Epidural and Intravenous opioids and non opioids |
To evaluate quality of recovery postoperatively after administration of IV fentanyl, IV paracetamol, Epidural Bupivacaine, Epidural bupivacaine with fentanyl. |
| Comparator Agent |
Epidural nonopioid |
Inj. Bupivacaine 0.25% 8ml via epidural catheter |
| Comparator Agent |
Epidural opioid |
Inj Bupivacaine 0.25% with Inj fentanyl 0.3 mcg/kg as adjuvant after placement of epidural catheter |
| Comparator Agent |
Intravenous non opioids |
Inj. Paracetamol 1gm IV as premedication followed by repeat analgesia as per duration of action and rescue analgesia when NRS more than 4 postoperatively |
| Comparator Agent |
Intravenous opioids |
Inj. Fentanyl 1-2mcg IV as premedication followed by repeat analgesia as per duration of action and then rescue analgesia when NRS more than 4 postoperatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Known gastrointestinal or genitourinary cancer patients
ASA grade III-IV
Patients undergoing oncological abdominal surgeries under general anaesthesia
|
|
| ExclusionCriteria |
| Details |
1) Patient refusal 2) BMI ≥ 30 kg/m 2
3) Clinically significant neurologic, psychiatric, CVS 4) Critically ill patient
renal, respiratory and hepatic disease
5) Coagulation abnormalities 6) Local infection (for epidural)
7) Allergy to study drugs, pregnancy, drug abuse/ 8) Those who received analgesic, anxiolytic, antipschyciatric substance abuse medication within 6 hours before surgery
9) Redo surgery
10)Failure of extubation within 6 hours of surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Postoperative Quality of recovery using QoR 15 score
|
1 week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Immediate Aldrete score
Return of bowel function in terms of peristalsis
Time taken for first enteral feed
Duration of hospital stay
Incidence of drug related side effectsÂ
|
Postoperative Quality of recovery using QoR 15 score every 24h till hospital stay.
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective randomized controlled study comparing postoperative quality of recovery using QoR 15 questionnaire after administration of intravenous versus epidural opioids or non opioids in patients undergoing oncological abdominal surgeries under general anaesthesia. There are fours groups i.e. Group A will receive intravenous fentanyl 1-2 mcg as premedication, Group B will receive intravenous paracetamol 1 gm, Group C will receive Inj Bupivacaine 0.25% 8ml via epidural catheter, Group D will receive Inj Bupivacaine 0.25% with fentanyl 0.3mcg/kg via epidural catheter. General anaesthesia will be given as per standard technique. Repeat analgesia will be given as per duration of action of respective mode of analgesia given.The patients will then be transferred to the post anaesthesia care unit and monitored for pain at regular time intervals using an 11 point Numerical Rating Scale(NRS). If NRS> 4, then rescue analgesia will be given as per the group assigned. The patients will be followed up every 24 hours for 1 week to assess the quality of recovery using QoR 15 score. |