| CTRI Number |
CTRI/2017/05/008588 [Registered on: 17/05/2017] Trial Registered Prospectively |
| Last Modified On: |
16/05/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Duration of Pain relief using two different intrathecal opoids (Nalbuphine vs. Fentanyl) in lower limb surgeries. |
|
Scientific Title of Study
|
Comparative Study Between Intrathecal Nalbuphine and Fentanyl as adjuvant with Ropivacaine in lower limb surgeries: A Prospective, Randomized,Double Blind Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yashpal Singh |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University, Varanasi |
| Address |
Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
919918424416 |
| Fax |
|
| Email |
dryashacin1999@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yashpal Singh |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University, Varanasi |
| Address |
Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi
UTTAR PRADESH
221005
India |
| Phone |
919918424416 |
| Fax |
|
| Email |
dryashacin1999@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yashpal Singh |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University, Varanasi |
| Address |
Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi
UTTAR PRADESH
221005
India |
| Phone |
919918424416 |
| Fax |
|
| Email |
dryashacin1999@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Other [None] |
|
|
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 Yashpal Singh |
Banaras Hindu University |
Sir Sunderlal Hospital (SSH). Department of Anaesthesiology
2nd floor, O.T Complex
Varanasi
UTTAR PRADESH |
919918424416
dryashacin1999@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institunal ethical commette, Faculty of Medicine, IMS, BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Age between 18 to 60 years, ASA I and II, both male and female patients undergoing lower limb surgery. , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj. Fentanyl 25mcg |
Inj. Fentanyl 25mcg (Trofentyl 50mcg/ml,from Troikaa Pharmaceuticals ) given intrathecally along with Ropivacaine. |
| Intervention |
Inj. Nelbuphine 500mcg |
Inj. Nelbuphine hydro chloride 500mcg (Inj.Ruffy 10mg/ml, Dr. Reddy Laoratories Ltd.), given intrthecally along with ropivacaine. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 18 to 60 yrs with ASA I & II, of either sex, undergoing lower limb surgeries. |
|
| ExclusionCriteria |
| Details |
-Pre-existing neurological deficit/peripheral neuropathy
-Coagulation disorders
-Local infection at the site of block.
-Pregnancy
-History of allergy to amide local anesthetics
-Patient refusal to participate in the study
-Patient having cardio or respiratory system failure
-Uncooperative patients.
-Patient with h/o end organ damage
|
|
|
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 |
| Duration of Analgesia and block characteristics |
12 hr. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamics and adverse event |
12 hr. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
19/06/2017 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Intrathecal opoids are synergistic with local anaesthtics and intensify the sensory block without increasing the sympathetic block. They are commonly added to local anaesthetic for potentiating their effects, reducing their doses, and thereby reducing their complication and side effect. They also prolong the duration of post operative analgesia. Few studies investigated intrathecal nalbuphine with hyberbaric bupivacaine , and as for as we know, no study had been done using isobaric ropivacaine as local anaesthetic and intrathecal nelbuphine are added as adjuant and compared for it postoperative analgesic effects with fentanyl.
The study is a randomized, double blind, parallel group trial comparing effeicacy and safety of intrathecal nalbuphine 500mcg and Fentanyl 25mcg with newer local anaesthetics isobaric Ropivacaine. The patient will be divided randomly using computer generated number into two equal groups (n=50) : Group RN will receive 0.75% ropivacaine (2.5ml) and 0.5ml nalbuphine (500mcg), Group RF will receive 0.75% of ropivacaine (2.5ml) 0.5ml fentanyl (25mcg). All patients are clinically assessed and routein preop. investigation will be done before procedure. Baseline parameter will be noted on arrival to OT room or preop room. All patient will be pre-loaded with Ringer solution 10ml/kg before procedure. Under all aseptic and antiseptic precaution dural puncture was performed in sitting position in L3-L4 interspce with a 25 G Quinke spinal needle. Intraoperatively HR, NIBP, RR, SpO2 were recorded at 5 minute interval. Primary outcome measures will be duration of analgesia and Block characteristics ( onset and duration of sensory and motor block). The secondary outcome will be changes in hemodynamics and adverse side effects. |