| CTRI Number |
CTRI/2024/05/067057 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
06/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Spinal anaesthesia with two different drugs as adjuvants in cesarean section |
|
Scientific Title of Study
|
A prospective observational study of intrathecal hyperbaric ropivacaine with nalbuphine or dexmedetomidine as adjuvants for cesarean section |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bharanidharan |
| Designation |
2nd year anaesthesia resident |
| Affiliation |
Government medical College surat new civil hospital surat |
| Address |
2nd Floor, Old college building, Department of Anesthesia, Government Medical college-Surat, near Majura gate Surat GUJARAT 395001 India
Surat GUJARAT 395001 India |
| Phone |
9514277481 |
| Fax |
|
| Email |
bharani4811156@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr.Bansari N kantharia |
| Designation |
Additional professor |
| Affiliation |
Government medical College surat new civil hospital surat |
| Address |
2nd Floor, Old college building, Department of Anesthesia, Government Medical college-Surat, near Majura gate Surat Gujarat India 395001 India
Surat GUJARAT 395001 India |
| Phone |
9825690177 |
| Fax |
|
| Email |
bansarikantharia@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr.Bansari N kantharia |
| Designation |
Additional professor |
| Affiliation |
medical College surat new civil hospital surat |
| Address |
2nd Floor, Old college building, Department of Anesthesia, Government Medical college-Surat, near Majura gate Surat Gujarat India 395001 India
Surat GUJARAT 395001 India |
| Phone |
9825690177 |
| Fax |
|
| Email |
bansarikantharia@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| 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 |
| DrBharanidharan |
New civil hospital surat |
First floor operation theatre, Obstetrics and gynaecology theatre,Civil hospital surat,Near majura gate surat,Gujarat India Surat GUJARAT |
9514277481
bharani4811156@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human research ethics committee GMC SURAT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients posted for elective or emergency caesarean section receiving spinal anaesthesia Patients in the age group of 18-40 years
Patients belonging to ASA grade I, II or III
Patients giving written informed consent |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Onset and duration of sensory & motor blockade
Duration of post operative analgesia and 24 hours analgesic requirement |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sensory assessment: pin prick method
Modified Bromage scale
Apgar score
Visual analogue scale score for pain
Ramsay sedation score |
Till 24 hrs after spinal anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
17/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/05/2024 |
| 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 Yet Recruiting |
| 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
|
Spinal anaesthesia is technique of choice for anaesthesia in patients undergoing caesarean section due to its rapid onset, decreased blood loss intense analgesia ,awake mother to permit bondage between mother and newborn,allowing early breastfeeding,early ambulation to the mother and minimizes the incidence of deep vein thrombosis while avoiding the complications of general anesthesia¹.The limitations of single shot spinal anaesthesia are it’s short duration of action and the need to supplement with parentral analgesics in the immediate post operative period .Several adjuvants have been added to prolong the duration of single shot spinal anaesthesia such as fentanyl, Dexmedetomidine, nalbuphine,clonidineetc...It has been added to local anesthetics to improve the quality of blockade and also to prolong the duration of post operative analgesia. Ropivacaine has a lower central nervous and cardiac toxic potential than bupivacaine .Additionally ropivacaine is less potent and causes shorter duration of motor blockade than bupivacaine.Thus,hyperbaric ropivacaine is usually used for cesarean section ². Short duration of Ropivacaine cannot prevent visceral pain so analgesia supplementation in the intraoperative period or early analgesic intervention in the post operative period is often required. Nalbuphine is highly lipid soluble opioid with agonist at ĸ receptors and weak agonist and antagonist at µ receptor. It is without significant effects on delta receptor. Nalbuphine has the potential to maintain or even enhance mu opioid based analgesia while simultaneously mitigating the common mu-opioid side effects. Nalbuphine elicits analgesia through a complex interaction of supraspinal ĸ3 and spinal ĸ1 mechanism and provides potent analgesia at spinal level.Nalbuphine acts primarily at the level of the first synapse in the nociceptive system in producing analgesia³. The respiratory depression is lesser than other opiods and has a safety profile with minimal effect on cardiovascular function and other side effects like nausea, vomiting ,constipation and psychotomimetic effects. It has minimal haemodynamic effects. Dexmedetomidine is a highly selective alpha 2 adrenoceptoragonist,sedative,anxiolytic,analgesic,sympatholytic and antinociceptive characteristics.It mediates central alpha 2A and imidazoline type 1 receptors activation which results in decrease of norepinephrine release and leads to decrease in blood pressure and heart rate² .Both primary analgesic effects and potentiation of opioid induced analgesia result from activation of alpha 2 adrenergic receptors in dorsal horn of spinal cord and inhibition of substance P release and it’s hallmark is its analgesic efficacy without any respiratory depression .So far to my knowledge there is no study comparing hyperbaric ropivacaine with nalbuphine and Dexmedetomidine. |