| CTRI Number |
CTRI/2025/10/096679 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of fentanyl and hyperbaric ropivacaine (0.75 percent) given in spinal anesthesia as a mixture versus sequentially for patients undergoing perianal surgeries |
|
Scientific Title of Study
|
Efficacy of intrathecal fentanyl and hyperbaric ropivacaine (0.75 percent) administered as a mixture or sequentially in subarachnoid block in patients for perianal surgeries: a prospective comparative study |
| 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 Aakifah Mariam |
| Designation |
Post graduate |
| Affiliation |
Dr B R Ambedkar Medical College and Hospital |
| Address |
Department Of Anaesthesiology, Dr B R Ambedkar Medical College and Hospital, Kadugondanahalli
Bangalore
KARNATAKA
560045
India |
| Phone |
7022055321 |
| Fax |
|
| Email |
aakifah.mariam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Nandini C V |
| Designation |
Associate Professor |
| Affiliation |
Dr B R Ambedkar Medical College and Hospital |
| Address |
Department Of Anaesthesiology, Dr B R Ambedkar Medical College and Hospital, Kadugondanahalli
Bangalore
KARNATAKA
560045
India |
| Phone |
9535024072 |
| Fax |
|
| Email |
nandinivraj@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aakifah Mariam |
| Designation |
Post graduate |
| Affiliation |
Dr B R Ambedkar Medical College and Hospital |
| Address |
Department Of Anaesthesiology, Dr B R Ambedkar Medical College and Hospital, Kadugondanahalli
Bangalore
KARNATAKA
560045
India |
| Phone |
7022055321 |
| Fax |
|
| Email |
aakifah.mariam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr B R Ambedkar Medical College and Hospital, Kadugondanahalli, Bangalore Karnataka 560045 |
|
|
Primary Sponsor
|
| Name |
Dr Aakifah Mariam |
| Address |
Department Of Anaesthesiology, Dr B R Ambedkar Medical College and Hospital, Kadugondanahalli Bangalore 560045 |
| 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 |
| Dr Aakifah Mariam |
Dr B R Ambedkar Medical College |
Major OT Complex 3rd floor
Department Of Anaesthesiology
Bangalore
KARNATAKA |
7022055321
aakifah.mariam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee, Dr BR Ambedkar Medical College |
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 |
Mixed solution of Fentanyl 25mcg and Hyperbaric ropivacaine 0.75percent 15mg |
Fentanyl 25mcg and Hyperbaric ropivacaine 0.75percent 15mg mixed solution given once intrathecally during subarachnoid block for perianal surgeries |
| Comparator Agent |
Sequential injection of Fentanyl 25mcg and Hyperbaric ropivacaine 0.75percent 15mg |
Fentanyl 25mcg and Hyperbaric ropivacaine 0.75percent 15mg given intrathecally once sequentially in subarachnoid block for perianal surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are posted for perianal surgery belonging to ASA 1 or 2 |
|
| ExclusionCriteria |
| Details |
Patients who have coagulation or bleeding disorders
Patients with raised intracranial pressure
Local site infection
Patient refusal
Known allergy to the study drug
H/o spine surgeries, patient with spine deformity
BMI greater than 35kg/m2 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To note the onset and time taken to achieve maximum height of sensory and motor blockade of intervention and comparator agent |
At baseline, at 2minutes, at 4minutes, at 6minutes, at 8minutes, at10minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess total duration of sensory & motor blockade |
At 2nd hour postoperative, at 4th hour postoperative, at 6th hour postoperative, at 8th hour postoperative, at 12th hour postperative. |
| To note time required for first rescue analgesia |
At 4th hour postoperative, at 6th hour postoperative, at 8th hour postoperative, at 12th hour postperative. |
| To assess haemodynamic parameters & adverse events |
At baseline, at 2nd hour postoperative, at 4th hour postoperative, at 6th hour postoperative, at 8th hour postoperative, at 10th hour postperative, at 12th hour postoperative |
|
|
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)
|
10/11/2025 |
| 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
|
Subarachnoid block (SAB) is the most common regional anaesthesia technique done for infraumbilical surgeries due to its less cost and lower incidence of major perioperative complications, achieved by a limited and localised action of the drug. It offers an advantage of profound nerve block which can be achieved by injecting a small amount of local anaesthetic intrathecally. It is a reliable, effective and safe technique with predictable benefits, and has been the procedure of choice for perianal surgeries unless contraindicated.
Ropivacaine is an amide local anaesthetic. It blocks the nerve fibers which transmit pain (A delta and C fibers) to a greater degree than those fibers which are involved in motor function (A beta fibers). It has a shorter duration of sensory and motor block, thereby it minimizes the psychological discomfort of being immobile for longer duration. It also has reduced potential for neurotoxicity and cardiotoxicity, thus making it a choice for shorter outpatient procedures.
To prolong the duration of analgesia and decrease the adverse effects of high dose of local anaesthetic agents, adjuvants are commonly used. The neuraxial adjuvant of choice is fentanyl for its rapid onset and shorter duration of action due to its re-distribution intrathecally. The combination of local anaesthetic with fentanyl is synergistic, which helps to enhance the block characteristics. The synergistic effect reduces visceral and somatic pain and the requirement for need of post operative analgesics.
Baricity is defined as the ratio of the density of local anesthetic and cerebrospinal fluid (CSF). The density of cerebrospinal fluid (CSF) at 37°C is 1.00059 g/ml while that of fentanyl is 0.99410 g/ml. The baricity of hyperbaric ropivacaine is 1.02980 g/ml which is almost close to that of CSF.
Mixing hyperbaric local anaesthetic with adjuvants in a single syringe for intrathecal administration is a common practice. This premixed solution alters the density of local anaesthetic solution affecting its spread in the CSF. Whereas, when the local anaesthetic solution and adjuvant is administered sequentially it minimizes the change in density and pH of both drugs, hence preventing any alteration in CSF spread.
Hence the rationale behind performing this study to see differences in block characteristics of Hyperbaric Ropivacaine (0.75%) with Fentanyl (25 mcg) administered as a mixture and as sequentially. Also the haemodynamic parameters and duration of post operative analgesia will be assessed. |