| CTRI Number |
CTRI/2022/10/046357 [Registered on: 11/10/2022] Trial Registered Prospectively |
| Last Modified On: |
30/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study the effects of two different doses of injection hyperbaric ropivacaine in spinal anaesthesia for lower abdominal and leg surgeries. |
|
Scientific Title of Study
|
Comparison of two different doses of hyperbaric ropivacaine in spinal anaesthesia for infraumbilical surgeries- a randomized controlled trial. |
| Trial Acronym |
ROSA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prashant Atmaram Lomate |
| Designation |
Professor |
| Affiliation |
Medical college |
| Address |
Department of Anaesthesia, Bharati Vidyapeeth (deemed to be university) Medical College and Hospital,Sangli. District-Sangli.
Department of Anaesthesia, Bharati Vidyapeeth (deemed to be university) Medical college and Hospital,Sangli. Dist-Sangli.
Sangli
MAHARASHTRA
416414
India |
| Phone |
02332212780 |
| Fax |
0233-2212779 |
| Email |
drprashantlomate@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashant Atmaram Lomate |
| Designation |
Professor |
| Affiliation |
medical college |
| Address |
Department of Anaesthesia, Bharati Vidyapeeth (deemed to be university) Medical College and Hospital,Sangli. Dist-Sangli.
Department of Anaesthesia, Bharati Vidyapeeth (deemed to be university) Medical College and Hospital,Sangli. Dist-Sangli.
Sangli
MAHARASHTRA
416414
India |
| Phone |
02332212780 |
| Fax |
0233-2212779 |
| Email |
drprashantlomate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashant Atmaram Lomate |
| Designation |
Professor |
| Affiliation |
Medical college |
| Address |
Department of Anaesthesia, Bharati Vidyapeeth (deemed to be university) Medical College and Hospital,Sangli. Dist-Sangli.
Department of Anaesthesia, Bharati Vidyapeeth (deemed to be university) Medical College and Hospital,Sangli. Dist-Sangli.
Sangli
MAHARASHTRA
416414
India |
| Phone |
02332212780 |
| Fax |
0233-2212779 |
| Email |
drprashantlomate@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati vidyapeeth (deemed to be university)medical college and hospital, sangli, maharashtra. |
|
|
Primary Sponsor
|
| Name |
Dr Prashant Atmaram Lomate |
| Address |
Department of Anaesthesia, Bharati Vidyapeeth (deemed to be university) Medical College and Hospital,sangli. Dist- Sangli. |
| Type of Sponsor |
Other [self] |
|
|
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 Prashant Atmaram Lomate |
Bharati Vidyapeeth (deemed to be university) Medical College and Hospital, Sangli. |
Professors chamber, Department of Anaesthesia, near operation theatre complex, C wing, second floor.
Sangli
MAHARASHTRA |
09823295177
0233-2212779
drprashantlomate@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati vidyapeeth (deemed to be university)medical college and hospital, Sangli. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection 0.75% hyperbaric ropivacaine. |
Dose- 2.4cc. Route of administration- Intrathecal for spinal anaesthesia.Frequency of administration- Single shot. Duration of monitoring-For six hours after drug administration or till the effect of spinal anesthesia wears off. For below umbilical surgeries, under all aseptic precautions, dural puncture will be done with 25G spinal needle. Once free flow of CSF is achieved, 2.4 ml of 0.75% hyperbaric ropivacaine will be injected into the subarachnoid space.Sensory-motor block onset and offset times, duration of analgesia and haemodynamic parameters will be recorded at specific time intervals intra and postoperatively for six hours. At the end of study, data will be tabulated and compared with the first group. |
| Intervention |
Injection 0.75% hyperbaric ropivacaine. |
Dose- 2cc. Route of administration- Intrathecal for spinal anaesthesia.Frequency of administration- Single shot. Duration of monitoring-For six hours after drug administration or till the effect of spinal anesthesia wears off. For below umbilical surgeries, under all aseptic precautions, dural puncture will be done with 25G spinal needle. Once free flow of CSF is achieved, 2 ml of 0.75% hyperbaric ropivacaine will be injected into the subarachnoid space.Sensory-motor block onset and offset times, duration of analgesia and haemodynamic parameters will be recorded at specific time intervals intra and postoperatively for 6 hours. At the end of study, data will be tabulated and compared with the second group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA grade I or grade II patients
2.Either sex
3.Age- 18 to 60 years
4.Scheduled for elective infraumbilical surgeries under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
1.Patient refusal to participate in the study.
2.Known hypersensitivity to local anaesthetics
3.Bleeding disorders
4.Anatomic abnormality of spine
5.Severe systemic diseases
6.Pregnant patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| duration of analgesia after 2cc and 2.4cc volumes of 0.75% hyperbaric ropivacaine when given for spinal anaesthesia during infraumbilical surgeries. |
duration of analgesia- assesses for 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.onset times of sensory and motor block.
2.duration of sensory and motor block
3.haemodynamic parameters [HR, SBP,DBP, MAP]
4. adverse effects of study drugs and incidence of discontinuation of therapy due to side effects.
|
1. Sensory block duration- for 6 hours.
2.motor block -for 6 hours. 3.VAS scores-for 6 hours. 4. HR, SBP,DBP,MAP, SPO2- for 6 hours. |
1.onset times of sensory and motor block.
2.duration of sensory and motor block
3.haemodynamic parameters [HR, SBP,DBP, MAP]
4. adverse effects of study drugs and incidence of discontinuation of therapy due to side effects.
|
1. Sensory block duration- for 6 hours.
2.motor block -for 6 hours. 3.VAS scores-for 6 hours. 4. HR, SBP,DBP,MAP, SPO2- for 6 hours. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
20/10/2022 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
the proposed RCT comparing the efficacy of two different volumes of 0.75% hyperbaric ropivacaine for spinal anaesthesia in infraumbilical surgeries is innovative. the primary and secondary outcomes of the study are expected to add greatly to the understanding of the ideal drug volume of inj ropivacaine. the central hypothesis of the proposed research is that the quality of spinal anaesthesia in terms of duration oof analgesia;and onset and offset times of sensory-motor blockade will be better with 2.4cc than 2cc of 0.75% hyperbaric ropivacaine during infraumbilical surgeries under spinal anaesthesia.
|