| CTRI Number |
CTRI/2020/06/025889 [Registered on: 15/06/2020] Trial Registered Prospectively |
| Last Modified On: |
12/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Giving block in the shoulder region to provide better and prolonged pain relief |
|
Scientific Title of Study
|
Comparison of Anaesthetic efficacy of Ropivacaine and Ropivacaine with Nalbuphine as an adjuvant for Ultrasound guided Supraclavicular Brachial plexus blockade: A Randomized Controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Arish RC/19/52 17/5/2019 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arish |
| Designation |
Assistant Professor, Department Of Anaesthesia |
| Affiliation |
Pondicherry Institute Of Medical Sciences |
| Address |
Arish
Department Of Anaesthesia
No 34, Main Road Kombakkam
Pondicherry Arish
Department Of Anaesthesia
Kalathumettupathai, Ganapathichettikulam, Village No.20, Kalapet, Puducherry, 605014 Pondicherry PONDICHERRY 605110 India |
| Phone |
9791853400 |
| Fax |
|
| Email |
thebeast11.bt@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Arish |
| Designation |
Assistant professor, Department Of Anaesthesia |
| Affiliation |
Pondicherry Institute Of Medical Sciences |
| Address |
Arish
Department Of Anaesthesia
No 34 Main Road
Kombakkam
Pondicherry Arish
Department Of Anaesthesia
Kalathumettupathai, Ganapathichettikulam, Village No.20, Kalapet, Puducherry, 605014 Pondicherry PONDICHERRY 605110 India |
| Phone |
9791853400 |
| Fax |
|
| Email |
thebeast11.bt@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Arish |
| Designation |
Assistant Professor, Department Of Anaesthesia |
| Affiliation |
Pondicherry Institute Of Medical Sciences |
| Address |
Arish
Department Of Anaesthesia
No 34 Main road Kombakkam
pondicherry Arish
Department Of Anaesthesia
Kalathumettupathai, Ganapathichettikulam, Village No.20, Kalapet, Puducherry, 605014 Pondicherry PONDICHERRY 605110 India |
| Phone |
9791853400 |
| Fax |
|
| Email |
thebeast11.bt@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Pondicherry Institute of medical science |
| Address |
Kalathumettupathai, Ganapathichettikulam,Village No 20 Kalapet,
Puducherry - 605014,
INDIA |
| 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 |
| Arish |
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES |
Department Of Anaesthesia
2nd Floor Emergency Building
Kalathumettupathai, Ganapathichettikulam, Village No.20, Kalapet, Puducherry, 605014 Pondicherry PONDICHERRY |
9791853400
thebeast11.bt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA I & ASA II undergoing elective upper limb surgeries
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ropivacaine and saline |
Injection Ropivacaine of 2ml/kg with 1 ml of saline will be given in supraclavicular brachial plexus block under ultrasound guided technique |
| Intervention |
ropivacaine with nalbuphine |
Injection Ropivacaine of 2ml/kg and 10mg of nalbuphine will be given in supraclavicular brachial plexus block under ultrasound guided technique |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society Of Anesthesiologists (ASA) Physical Status I To II Of Both Gender
Age Between 18 And 60 Years
Body Mass Index (BMI) <25 Kg/M2
Elective forearm and hand surgeries in orthopedic and plastic surgeries
|
|
| ExclusionCriteria |
| Details |
Allergy to local anesthetics or Nalbuphine
Infection at the injection site
Patients with clinically significant coagulopathy
Preexisting neuromuscular disorders
Severe cardiovascular, or pulmonary disease, renal or hepatic disorder
Pregnancy and lactation
Patients taking medications with opioid or receiving chronic analgesic therapy other than simple analgesics were excluded from the study.
|
|
|
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 and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of analgesia between ropivacaine and ropivacaine with nalbuphine for supraclavicular brachial plexus blockade |
after complete sensory blockade |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To measure the onset of sensory and motor blockade and
To measure the duration motor blockade between the two study groups
To measure the amount of rescue analgesia requirement in the first 24 hours
To measure the hemodynamic changes during the procedure |
after complete sensory and motor blockade till first resue analgesia |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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)
|
15/06/2020 |
| 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
|
Ropivacaine is a long-acting regional
anesthetic that is structurally related to bupivacaine. It is a S(−)
enantiomer, unlike bupivacaine, which is a racemate and well-established long-acting regional
anesthetic, which like all amide anesthetics has been associated with
cardiotoxicity when used in high concentration or when accidentally
administered intravascularly. Hence ropivacaine was developed for the purpose
of reducing potential toxicity and improving relative sensory and motor block
profiles. Various adjuvants have been added to local anesthetics in brachial
plexus block to achieve quick, dense, and prolonged block; however, the results
are either inconclusive or associated with side effects.
Nalbuphine, a derivative of
14-hydroxymorphine, is an agonist-antagonist opioid acting on µ (mu) receptors
as antagonist and κ (kappa) receptors as agonist with an analgesic potency
equal to morphine and its antagonistic potency is approximately ¼th of
that of naloxone. Unlike morphine, it exhibits a ceiling effect on respiratory
depression. Nalbuphine has the potential to maintain or even enhance
µ-opioid-based analgesia while simultaneously mitigating the µ-opioid side
effects.
Therefore the purpose of this study is to compare by adding nalbuphine with
ropivacaine in supraclavicular brachial plexus block and to know its efficacy. |