| CTRI Number |
CTRI/2016/02/006692 [Registered on: 29/02/2016] Trial Registered Prospectively |
| Last Modified On: |
23/02/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of combination of drugs on pain relief in patients undergoing surgery for fracture of lower limb |
|
Scientific Title of Study
|
Efficacy of preemptive multimodal analgesia for post operative pain relief in trauma patients undergoing lower limb surgery-A Randomised trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jeetinder kaur |
| Designation |
Additional Professor |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
| Address |
Department of Anesthesia
Nehru Hospital
PGIMER Sector 12, Chandigarh India Chandigarh CHANDIGARH 160012 India |
| Phone |
7087009510 |
| Fax |
|
| Email |
jeet1516@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Jeetinder kaur |
| Designation |
Additional Professor |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
| Address |
Department of Anesthesia
Nehru Hospital
PGIMER Sector 12, Chandigarh India
CHANDIGARH 160012 India |
| Phone |
7087009510 |
| Fax |
|
| Email |
jeet1516@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Jeetinder kaur |
| Designation |
Additional Professor |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
| Address |
Department of Anesthesia
Nehru Hospital
PGIMER Sector 12, Chandigarh India
CHANDIGARH 160012 India |
| Phone |
7087009510 |
| Fax |
|
| Email |
jeet1516@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education & Research, Sector 12, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute Of Medical Education Research |
| Address |
Sector 12, Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Jeetinder kaur makkar |
Advanced trauma centre |
Post Operative recovery room, 3rd floor, Advanced trauma centre, Post Graduate institute of Medical Education and research, Sector 12 Chandigarh CHANDIGARH |
7087009510
jeet1516@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 |
ASA status I to II patients undergoing post traumatic long bone surgeries of femur and tibia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group C |
Will not receive any premedication |
| Intervention |
Group PE |
This group will receive preemptive multimodal pharmacologic agents ;Intravenous diclofenac 75 mg, intravenous morphine 3mg, 1gm of intravenous acetaminophen and 75mg pregabalin per orally one hour before the start of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing post traumatic long bone surgeries of femur and tibia. |
|
| ExclusionCriteria |
| Details |
History of associated head injury, blunt trauma abdomen or blunt trauma chest 2) allergy and contraindications to any of the medications being used 3) history of being on chronic pain medications (i.e. slow-release preparations of opioids) 4) rheumatoid arthritis 4)psychiatric disorder 5) a history of diabetes with impaired renal function 6) morbid obese 7) patients unable or unwilling to use patient-controlled epidural analgesia (PCEA). (8) prior use of the investigated medications (9) current use of anticoagulants or antiplatelet medication |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean number of boluses of PCA or PCEA |
At 24 and 48 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean VAS scores in post operative period
Postoperative nausea, vomiting, sedation scores |
30 min, 1 hr, 2 hrs, 4hrs, 8hrs, 12 and 24 hrs and on postoperative day 2. |
|
|
Target Sample Size
|
Total Sample Size="250" Sample Size from India="250"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/03/2016 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Group PE will receive the following preemptive multimodal
pharmacologic agents-,Intravenous diclofenac 75 mg, intravenous morphine
3mg, 1gm of intravenous acetaminophen and 75mg pregabalin per orally.
After assessing for eligibility,
patients will be explained about the study protocol, the use of the PCA pump, numerical
rating score (NRS) and written informed consent will be obtained. All patients will be
explained to report pain intensity on a VAS score of 0-10 where 0= no pain and
10= worst possible pain. For descriptive purposes, pain score between 0-3 will
be taken as mild pain, 4-7 as moderate pain, 7-9 as severe pain and 10 as
intolerable pain.
One hour prior to surgery, the sealed
envelope will be opened and the card inside will determine the group allocation.
The drugs will
be administered at least 1 hour before surgery by a blinded anesthesiologist
who will not participate in post operative assessment.
After securing intravenous cannula and
adequate hydration with Ringer lactate , spinal anesthesia would be initiated
with 3ml of 0.5% hyperbaric bupivacaine. In case general anesthesia is required, standard institute protocol shall be followed. All patients will be managed
intraoperatively with combined spinal epidural anesthesia or general anesthesia with the same
perioperative departmental protocol. Type of surgery, duration of surgery,
baseline haemoglobin, blood loss, no of hypotensive episodes, intraoperative
blood transfusion, intraoperative use of opoids and NSAIDS will be noted. The
attending anesthesiologist will not be involved in the patients’ evaluation
post-operatively.
All patients will be connected to a patient-controlled epidural analgesia
pump (PCEA Plus; Abbott, Chicago, IL, USA) or Patient controlled analgesia upon arrival in the post-anesthesia
care unit.. The patients will be instructed to push
the button of the PCEA system or PCA each time they felt pain. The patient-controlled
analgesia will be set at a bolus of 5 ml of 0.2 % ropivacaine with 2μgm/ml of
fentanyl with a lockout time of 30 min in or 2ml of 1mg/kg morphine At any point of time, if patient
complains of pain with NRS>3, morphine 3mg will be given as rescue analgesia
and time recorded..
Postoperative NRS scores will be recorded when the patient is admitted to the
trauma recovery room, after 30 min, 1 hr, 2 hrs, 4hrs, 8hrs, 12 and 24 hrs and
on postoperative day 2. Postoperative nausea, vomiting, sedation scores will be
assessed at arrival time, 6 hrs and 24 hrs. Any episodes of respiratory
depression, apnea, hypoventilation, desaturation will be noted.
|