| CTRI Number |
CTRI/2018/04/013293 [Registered on: 16/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
08/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the postsurgical pain relieving effects of three groups of drugs in patient of open inguinal hernia repair posted under regional anaesthesia. |
|
Scientific Title of Study
|
Comparative study of preoperative oral pregabalin alone,pregabalin with dexamethasone and pregabalin with Vitamin B complex for postoperative analgesic requirement in open inguinal hernia repair under subarachanoid block. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepak Gupta |
| Designation |
DNB Resident (Secondary) |
| Affiliation |
Bhagat Phool Singh Government Medical College Khanpur(Kalan),Sonipat |
| Address |
Main Operation Theatre Complex,
Department of Anaesthesia
Bhagat Phool Singh Government Medical College For Women Khanpur Kalan,Sonipat,Haryana
Main Operation Theatre complex,Department of Anaesthesia Bhagat Phool Singh Government Medical College For Women Khanpur Kalan,Sonipat,Haryana
Sonipat
HARYANA
131305
India |
| Phone |
8059779684 |
| Fax |
|
| Email |
deepakgupta_lko@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Meenu Agrawal |
| Designation |
Associate Professor Department of Anaesthesia |
| Affiliation |
Bhagat Phool Singh Government Medical College For Women Khanpur Kalan,Sonipat,Haryana |
| Address |
Main Operation Theatre complex,
Department of Anaesthesia,
Bhagat Phool Singh Government Medical College For Women Khanpur Kalan,Sonipat,Haryana
29-A Sujan Singh Park
Old D.C.Road,Near Gurudwara
Sonipat,
Haryana
Sonipat
HARYANA
131305
India |
| Phone |
9467823780 |
| Fax |
|
| Email |
meenu297@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepak Gupta |
| Designation |
DNB Resident (Secondary) |
| Affiliation |
Bhagat Phool Singh Government Medical College For Women Khanpur Kalan,Sonipat,Haryana |
| Address |
Main Operation Theatre complex,
Department of Anaesthesia,
Bhagat Phool Singh Government Medical College For Women Khanpur Kalan,Sonipat,Haryana
Main Operation Theatre complex,
Department of Anaesthesia,
Bhagat Phool Singh Government Medical College For Women Khanpur Kalan,Sonipat,Haryana
Sonipat
HARYANA
131305
India |
| Phone |
8059779684 |
| Fax |
|
| Email |
deepakgupta_lko@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Bhagat Phool Singh Government Medical College For Women
Khanpur(Kalan),Sonipat |
|
|
Primary Sponsor
|
| Name |
Bhagat Phoot Singh Government Medical College For Women KhanpurKalan SonipatHaryana |
| Address |
Bhagat Phool Singh Government Medical College For Women Khanpur (Kalan) Sonipat,Haryana |
| Type of Sponsor |
Government 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 |
| Deepak Gupta |
Bhagat Phool Singh Government Medical College For Women Khanpur Kalan,Sonipat,Haryana |
Main Operation Theatre complex,Department of Anaesthesia
Bhagat Phool Singh Government Medical College For Women Khanpur Kalan,Sonipat,Haryana
Sonipat
HARYANA |
8059779684
deepakgupta_lko@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA GRADE 1 ,ASA GRADE 2, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
TABLET PREGABALIN,PREGABALIN WITH DEXAMETHASONE,PREGABALIN WITH VITAMIN B COMPLEX |
In Group I, Oral Capsule Pregabalin 300 mg Capsuleand IV placebo in 100ml NS( over 15 minutes) will be given 60 minutes prior to subarachnoid block .
In Group II,Oral Capsule Pregabain 300mg Capsuleand IV Dexamethasone 8 mg in100ml NS IV(over 15 miutes)will be given 60 minutes prior to subarachnoid block will be given at the time of subarachnoid block.
In Group III , Oral Capsule Pregabalin 300 mg Capsuleand intravenous Inj Vitamin B complex(Thiamine 1gm IV,pyridoxine hydrocloride 1gm iv,Cyanocobalamine 100mcg,Dexpanthenol 15mg) in 100ml NS( over 15 minutes, close watch for hypersensitivity reaction for 5 minutes,if present stop infusion and noted ) will be given60 minutes prior to subarachanoid block.
|
| Comparator Agent |
TABLET PREGABALIN,PREGABALIN WITH DEXAMETHASONE,PREGABALIN WITH VITAMIN B COMPLEX |
In Group I, Oral Capsule Pregabalin 300 mg Capsuleand IV placebo in 100ml NS( over 15 minutes) will be given 60 minutes prior to subarachnoid block . In Group II,Oral Capsule Pregabain 300mg Capsuleand IV Dexamethasone 8 mg in100ml NS IV(over 15 miutes)will be given 60 minutes prior to subarachnoid block will be given at the time of subarachnoid block. In Group III , Oral Capsule Pregabalin 300 mg Capsuleand intravenous Inj Vitamin B complex(Thiamine 1gm IV,pyridoxine hydrocloride 1gm iv,Cyanocobalamine 100mcg,Dexpanthenol 15mg) in 100ml NS( over 15 minutes, close watch for hypersensitivity reaction for 5 minutes,if present stop infusion and noted ) will be given60 minutes prior to subarachanoid block. |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient consented for the study
Patient of Age Group : 20-60 years Patients with American society of anaesthesiologists I or II
Patient of any gender posted for inguinal hernia repair. |
|
| ExclusionCriteria |
| Details |
Patients with refusal to enter the study
Patients with American society of anaesthesiologists III, IV or V
Pregnant females
Patient with History of Renal disease
Patient with History of seizure or other neurological disorders
Patient currently taking Gabapentin or Pregabalin for other medical purpose
Patient with known history of allergic reaction to pregabalin from previous use
Patients with known history of allergic reaction to vitamin b complex
Patients with comorbid diseases like diabetes, hypertension, neurological, psychiatric or neurovascular disorder
Patients having absolute contraindication for spinal anaesthesia like raised intracranial pressure, severe hypovolemia, bleeding diathesis and local infection . |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome will be to compare efficacy of drug combinations in prevention of postoperative pain .
|
upto 24 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secodary outcome is to compare haemodynamic staus and incidence of side effects. |
upto 24 hours |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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)
|
04/02/2018 |
| 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) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
PROJECT SUMMARY:
Prevention and treatment of postoperative pain continues to be a major concern in postoperative care and plays an important role in the early mobilization and well being of the surgical patient.Postoperative pain due to tissue injury and surgical trauma is associated with neuroendocrine stress responses, catecholamine,inflammatory mediator release, and central sensitization,which is considered to be one of the mechanisms responsible for the persistence of postoperative pain.Preventing central sensitization with multimodal analgesicinterventions could reduce the intensity or even eliminate acutepostoperative pain hyperalgesia and chronic pain after surgery.Role of pregabalinhas been established in literature for postoperative pain other than neuropathic painwith good results.[3,4]
On the other hand Dexamethasone is known to have some analgesic,antiemetic properties but its efficacy as an adjuvant analgesic for postoperative pain in cases under spinal anaesthesia is not studied extensively.
Recently few studies have shown the role of Vitamin B complex in Acute pain although there is limited literature supporting its adjuvant analgesic role for postoperative pain.However there is paucity of studies in comparison with pregabalin alone with dexamethasone and pregabalin with vitamin B complex for postoperative pain.
This study is designed to compare their efficacy with respect to increase in duration of analgesia, reduction in total post- operative requirements of analgesics and study side effects and complications in Three groups.One twentysix patients of either sex in ASA grade I and II were randomly allocated to one of the three groups of fortytwo each. The patients in Group I will be given single dose of oral capsulePregabalin 300mg with IV Placebo in 100ml NS( over 15 minutes) one hour prior to administration of spinal anaesthesia in patient of Open Inguinal hernia repair.Group II will be administered oral capsule Pregabalin 300mg with IV Inj Dexamethasone 8 mg in 100ml NS( over 15 minutes) one hour prior to administration of spinal anaesthesia in patient of open inguinal hernia repair.Group III will be administered oral capsule Pregabalin 300 mg with Inj VitaminB complex(Inj Thiamine 1gm, pyridoxine hydrocloride 1gm,Cyanocobalamine 100mcg,Dexpanthenol 15mg) in 100ml NS( over 15 minutes, close watch for hypersensitivity reaction for 5 minutes,if present stop infusion and noted )one hour prior to administration of spinal anaesthesia in patient of open inguinal hernia repair. The patients will be observed periopeatively for variations in haemodyanamic parameters, sedation scores and incidence of adverse effects among the groups.Postoperatively pain was assessed by Visual Analogue Scale immediate postoperatively and upto 24 hours thereafter. Time since spinal anaesthesia to first dose of analgesic and total dose of analgesic in first 24 hours will be recorded.
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