| CTRI Number |
CTRI/2023/10/058224 [Registered on: 04/10/2023] Trial Registered Prospectively |
| Last Modified On: |
28/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Spinal anaesthesia comparison between plain hyperbaric drug and drug with adjuvant combination in inguinal hernia open surgery |
|
Scientific Title of Study
|
A comparative study between plain hyperbaric ropivacaine versus hyperbaric ropivacaine versus hyperbaric ropivacaine with nalbuphine under spinal anaesthesia in patients undergoing open inguinal hernia mesh repair |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Renjan R I |
| Designation |
Junior Resident |
| Affiliation |
Rajarajeswari Medical college and Hospital |
| Address |
Department of Anaesthesiology, Rajarajeswari Medical College and Hospital, Mysore Road, Kambipura, Bangalore, Karnataka, India
Bangalore
KARNATAKA
560074
India |
| Phone |
7356132063 |
| Fax |
|
| Email |
frank.renjan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Karthik G S |
| Designation |
Professor |
| Affiliation |
Rajarajeswari Medical College and Hospital |
| Address |
Department of Anaesthesiology, Rajarajeswari Medical College and Hospital, Mysore Road, Kambipura, Bangalore, Karnataka, India
Bangalore
KARNATAKA
560074
India |
| Phone |
9538220515 |
| Fax |
|
| Email |
drgskarthik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Karthik G S |
| Designation |
Professor |
| Affiliation |
Rajarajeswari Medical College and Hopsital |
| Address |
Department of Anaesthesiology, Rajarajeswari Medical College and Hospital, Mysore Road, Kambipura, Bangalore, Karnataka, India
Bangalore
KARNATAKA
560074
India |
| Phone |
9538220515 |
| Fax |
|
| Email |
drgskarthik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari Medical College and Hospital, Kambipura, Mysore Road, Bangalore, Karnataka 560074 |
|
|
Primary Sponsor
|
| Name |
Rajarajeswari Medical College and Hospital |
| Address |
Mysore Road, Kambipura, Bangalore, Karnataka 560074 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Karthik G S |
Rajarajeswari Medical College and Hospital |
Department of Anaesthesiology, Kambipura, Mysore Road, Bangalore, Karnataka 560074
Bangalore
KARNATAKA |
9538220515
drgskarthik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Rajarajeswari Medical College and Hospital |
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 |
| Intervention |
Hyperbaric ropivacaine and nalbuphine |
Intrathecal administartion of hyperbaric ropivacaine 3ml + Inj. Nalbuphine 0.8mg reconstituted to 0.5 ml with sterile normal saline. Duration of analgesia will be assessed at regular intervals for 24 hours. |
| Comparator Agent |
Hyperbaric ropivacaine and sterile normal saline |
Intrathecal administration of hyperbaric ropivacaine 3ml + 0.5 ml sterile normal saline. Duration of analgesia will be assessed at regular intervals for 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1. ASA I and II male patients.
2. Patients undergoing elective unilateral open inguinal hernia repair.
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal.
2. Allergy to opioids and local anesthetics.
3. Morbidly obese patients.
4. Patients with coagulation abnormalities.
5. Previous spine surgeries and spinal deformities.
6. Mentally retarded patients.
7. Infection at the site of injection.
8. Patients having neurological abnormalities. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of adding 0.8mg of Nalbuphine to 0.75% hyperbaric Ropivacaine vs plain 0.75% hyperbaric Ropivacaine for unilateral inguinal hernia open mesh repair surgeries under spinal anaesthesia. |
Duration of analgesia in the first 24 hours post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess:
Time of onset of sensory and motor blockade.
Time of regression of segments of sensory blockade.
Time of regression of motor blockade.
Hemodynamic response.
Adverse effects if any.
Total analgesic consumption in 24 hours.
|
Intraoperative onset of motor and sensory blockade.
Intraoperative and postoperative regression of motor and sensory blockade. |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
09/10/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 a safe and effective form of anaesthesia which can be used as an
alternative to general anaesthesia commonly in surgeries involving the lower
extremities and surgeries below umbilicus which provides anaesthesia,
analgesia, motor and sensory blockade. The primary aim of this study will be to compare the effect of adding nalbuphine to 0.75% hyperbaric ropivacaine versus plain 0.75% hyperbaric ropivacaine in unilateral inguinal hernia open mesh repair surgeries in terms of total duration of analgesia, onset and duration of both motor and sensory blockade.
|