| CTRI Number |
CTRI/2024/05/066683 [Registered on: 02/05/2024] Trial Registered Prospectively |
| Last Modified On: |
01/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the postoperative recovery following laparoscopic cholecystectomy between patients receiving Enhanced recovery after surgery (ERAS) and Conventional treatment protocols
|
|
Scientific Title of Study
|
Comparision of Enhanced recovery after surgery (ERAS) Treatment
protocol vs Conventional treatment protocol on postoperative recovery in patients
undergoing laparoscopic cholecystectomy - A Randomized Controlled Trial. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
sanjicka velu |
| Designation |
Post graduate Junior resident |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Pondicherry Institute of Medical
Sciences campus,kalapet
Pondicherry
PONDICHERRY
605014
India
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9487420830 |
| Fax |
|
| Email |
Sanjickav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RAMYAVEL |
| Designation |
Professor |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Pondicherry Institute of Medical
Sciences campus,kalapet
Pondicherry
PONDICHERRY
605014
India
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9487630425 |
| Fax |
|
| Email |
ramyavel1988@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
sanjicka velu |
| Designation |
Post graduate Junior resident |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Pondicherry Institute of Medical
Sciences campus,kalapet
Pondicherry
PONDICHERRY
605014
India
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9487420830 |
| Fax |
|
| Email |
Sanjickav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pondicherry Institute of Medical Sciences
|
|
|
Primary Sponsor
|
| Name |
Pondicherry Institute of Medical Sciences |
| Address |
Pondicherry Institute of Medical Sciences,Ganapathichettikulam
,Kalapet,Puducherry-605014 |
| 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 |
| Sanjicka velu |
Pondicherry Institute of Medical Sciences Hospital |
Department of Anaesthesiology, Pondicherry Institute of Medical
Sciences campus,kalapet
Pondicherry
PONDICHERRY
605014
India
Pondicherry
PONDICHERRY |
9487420830
Sanjickav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS INSTITUTE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional treatment protocol on postoperative recovery in patients undergoing laparoscopic cholecystectomy |
The patient will undergo Conventional treatment protocol during pre operatively intra operatively and post Operatively .
Duration -From the preoperative night to till the time of discharge.
Pre-op:
o Conventional informed consent.
o No ponv assessment, standard pre
medication in the form of T.Pan 40 mg
&T.Emeset 4 mg given.
o No Pre emptive analgesics given.
o NPO as per standard fasting guidelines.
INTRA -OP:
o Balanced Anaesthesia protocol will be
followed.
o Temperature monitoring not done.
However, warmers used.
o Standard fluid administration guidelines
will be followed intraoperatively.
o Standard analgesics will be followed in
discretion with surgeon & anesthioloigest.
POST-OP:
o Standard analgesics will be followed
o No Postop early physiotherapy &exercise
will be done.
The anesthetist will be assessing the following outcome
parameters at the following frequencies.
1) Post-operative Length of hospital stay: The time from postoperative day
0 to till the day of discharge will be taken as postoperative length of hospital
stay.
2) Quality of recovery using QOR-40 Questionnaire: Before surgery
during the pre operative visit the QOR version will be explained and the
questionnaire will be completed once. Postoperatively the questionnaire will
be reevaluated at Day1&2.
3) NRS: Post operatively patient will be assessed for pain for every 2 hours
till first 8 hour and then every 4 hours till first 24 hours using NRS scale.
4) Grading of PONV: After shifting to recovery, patient will be assessed
postoperatively every 4 hourly for the presence of any retching, nausea or
vomiting for 24 hours and will be graded using a scale.
5) Total opioid consumption: The total amount of Tramadol consumed
postoperatively will be recorded.
6) Time to first oral intake: The time to first intake of liquids, solids to be
recorded.
7) Time to first mobilization: The time to first ambulation out of bed to be
recorded. |
| Intervention |
Enhanced recovery after surgery (ERAS) Treatment protocol on postoperative recovery in patients undergoing laparoscopic cholecystectomy
|
The patient will undergo ERAS treatment protocol during pre operatively intra operatively and post operatively.
Duration -From preoperative night to till the time of discharge
PRE-OP: o Pre op counselling given to patient. o Pre op assessment of ponv risk scale, QOR 40 Questionnaire will be assessed. o Pre emptive analgesics given on HS &7am. o Carbohydrate loading will be done at around 10-11 pm and at 5am. INTRA -OP: o Anaesthesia protocol will be followed. o Normothermia will be maintained. o Zero balance fluid therapy approach will be adopted. o Opioids sparing Multimodal analgesics will be given. o Prevention of ponv. POST-OP: o Multimodal analgesia will be given o Postop early physiotherapy &exercise will be done.
The anesthetist will be assessing the following outcome
parameters at the following frequencies.
1) Post-operative Length of hospital stay: The time from postoperative day
0 to till the day of discharge will be taken as postoperative length of hospital
stay.
2) Quality of recovery using QOR-40 Questionnaire: Before surgery
during the pre operative visit the QOR version will be explained and the
questionnaire will be completed once. Postoperatively the questionnaire will
be reevaluated at Day1&2.
3) NRS: Post operatively patient will be assessed for pain for every 2 hours
till first 8 hour and then every 4 hours till first 24 hours using NRS scale.
4) Grading of PONV: After shifting to recovery, patient will be assessed
postoperatively every 4 hourly for the presence of any retching, nausea or
vomiting for 24 hours and will be graded using a scale.
5) Total opioid consumption: The total amount of Tramadol consumed
postoperatively will be recorded.
6) Time to first oral intake: The time to first intake of liquids, solids to be
recorded.
7) Time to first mobilization: The time to first ambulation out of bed to be
recorded.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients belonging to ASA physical status
classification I & II.
Patients scheduled for elective Laparoscopic cholecystectomy procedures
under General Anesthesia. |
|
| ExclusionCriteria |
| Details |
1.Patients with history of motion sickness.
2. Patients with history of chronic pain /prolonged pain medications / Opioid
abuse.
3.Patients with history of use of anti-convulsant.
4.Patients with BMI more than fourty.
5.Pregnant patients.
6.Patients with history of Psychiatric disease/ Drug abuse |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Post-operative Length of hospital stay.
|
The time from postoperative day
0 to till the day of discharge
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of recovery using QOR-40 Questionnaire.
NRS post operative pain.
Grading of PONV.
Total opioid consumption.
Time to first oral intake.
Time to first mobilization. |
From a day prior to surgery to post operative day 2 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/05/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
In comparing the two groups the group in which ERAS treatment protocal was given than conventional treatment protocal had the good post operative recovery, the duration of length of hospital stay were reduced. Thus,patients receiving ERAS treatment protocal has better characteristics than patient’s receiving conventional treatment protocal . |