| CTRI Number |
CTRI/2025/04/084807 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of spinal anesthesia using levo-bupivacaine of 3 different densities to see which one works best for pain relief and recovery after surgery. |
|
Scientific Title of Study
|
Comparison of quality and recovery profile of subarachnoid block using either 0.5% hyperbaric, 0.5% isobaric or sequential hyperbaric followed by isobaric levo-bupivacaine : a double blind randomized comparative study. |
| Trial Acronym |
- |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Eshan Mathur |
| Designation |
PG Resident 2nd Year |
| Affiliation |
Mahatma Gandhi Medical College and Hospital |
| Address |
2nd Floor OT Complex Department of Anaesthesia at Mahatma
Gandhi Medical College and Hospital Sitapura Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9414841253 |
| Fax |
|
| Email |
eshanmathur.94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mangilal Deganwa |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Medical College and Hospital |
| Address |
2nd Floor OT Complex OT No 8 Orthopedic OT Department of
Anaesthesia at Mahatma Gandhi Medical College And Hospital Sitapura
Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9871495240 |
| Fax |
|
| Email |
mangilaldeganwa0606@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mangilal Deganwa |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Medical College and Hospital |
| Address |
2nd Floor OT Complex OT No 8 Orthopedic OT Department of
Anaesthesia at Mahatma Gandhi Medical College And Hospital Sitapura
Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9871495240 |
| Fax |
|
| Email |
mangilaldeganwa0606@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Hospital Jaipur |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College and Hospital |
| Address |
Department of Anaesthesiology And Critical Care Mahatma Gandhi
Medical College and Hospital Sitapura Jaipur |
| 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 Eshan Mathur |
Mahatma Gandhi Medical College and Hospital |
Department of
Anaesthesiology
Critical Care and Pain
Management OT
Complex Second
Floor Main Hospital
Building
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN |
9414841253
eshanmathur.94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Mahatma Gandhi Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N433||Hydrocele, unspecified, (2) ICD-10 Condition: N471||Phimosis, (3) ICD-10 Condition: N452||Orchitis, (4) ICD-10 Condition: N453||Epididymo-orchitis, (5) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis, (6) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (7) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (8) ICD-10 Condition: N210||Calculus in bladder, (9) ICD-10 Condition: N211||Calculus in urethra, (10) ICD-10 Condition: K601||Chronic anal fissure, (11) ICD-10 Condition: K603||Anal fistula, (12) ICD-10 Condition: N812||Incomplete uterovaginal prolapse, (13) ICD-10 Condition: N813||Complete uterovaginal prolapse, (14) ICD-10 Condition: M161||Unilateral primary osteoarthritisof hip, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Subarachnoid block given using hyperbaric 0.5% levobupivacaine |
On arrival of the patient in the operating room, intravenous access was obtained in the upper limb with 18G cannula and a preload of 500 mL of Ringer Lactate (10 ml/kg) solution was administered. Standard monitors like ECG, Pulse oximeter , non-invasive blood pressure will be connected. Patient was placed in the sitting position and subarachnoid block was given with 25G Quinckes needle using 3 ml of hyperbaric 0.5% levobupivacaine at L3-L4 intervertebral space using a midline approach. The injection of local anaesthetic solutions will be given gradually over a period of 10-15 seconds after negative aspiration for blood and CSF accordingly. Immediately after subarachnoid block patient will be placed supine. The blinded anaesthesiologist will use the modified Bromage scale to check on the motor block every 5 minutes (1: Complete movement, 2: Unable to flex the hips, can bend the knee, 3: Unable to flex knee yet able to flex the ankle and 4: No movement). The time needed to reach Bromage 3 before surgery and regress to Bromage 0 after surgery will be recorded. Heart rate (HR), mean arterial pressure (MAP), sensory and motor blockade will be measured at baseline, 5, 10, 15, 20, 25, 30, 45, 60 and 120 minutes after the injection by the blinded anaesthesiologist. Post-operative complications will be recorded, such as hypotension (defined as MAP 65 mmHg or decrease in basal MAP by 20% and will be treated with IV fluids), bradycardia (defined as HR 50 beats/min and will be treated by IV atropine 0.02 mg/kg), shivering (will be treated by tramadol 50 mg in IV drip), nausea, vomiting (will be treated by IV ondansetron 4 mg), PDPH, discomfort.
|
| Intervention |
Subarachnoid block given using isobaric 0.5% levobupivacaine |
On arrival of the patient in the operating room, intravenous access was obtained in the upper limb with 18G cannula and a preload of 500 mL of Ringer Lactate (10 ml/kg) solution was administered. Standard monitors like ECG, Pulse oximeter , non-invasive blood pressure will be connected. Patient was placed in the sitting position and subarachnoid block was given with 25G Quinckes needle using 3 ml of isobaric 0.5% levobupivacaine at L3-L4 intervertebral space using a midline approach. The injection of local anaesthetic solutions will be given gradually over a period of 10-15 seconds after negative aspiration for blood and CSF accordingly. Immediately after subarachnoid block patient will be placed supine. The blinded anaesthesiologist will use the modified Bromage scale to check on the motor block every 5 minutes (1: Complete movement, 2: Unable to flex the hips, can bend the knee, 3: Unable to flex knee yet able to flex the ankle and 4: No movement). The time needed to reach Bromage 3 before surgery and regress to Bromage 0 after surgery will be recorded. Heart rate (HR), mean arterial pressure (MAP), sensory and motor blockade will be measured at baseline, 5, 10, 15, 20, 25, 30, 45, 60 and 120 minutes after the injection by the blinded anaesthesiologist. Post-operative complications will be recorded, such as hypotension (defined as MAP 65 mmHg or decrease in basal MAP by 20% and will be treated with IV fluids), bradycardia (defined as HR 50 beats/min and will be treated by IV atropine 0.02 mg/kg), shivering (will be treated by tramadol 50 mg in IV drip), nausea, vomiting (will be treated by IV ondansetron 4 mg), PDPH, discomfort.
|
| Intervention |
Subarachnoid block given using sequential hyperbaric 0.5% levobupivacaine followed by isobaric 0.5% levobupivacaine. |
On arrival of the patient in the operating room, intravenous access was be obtained in the upper limb with 18G cannula and a preload of 500 mL of Ringer Lactate (10 ml/kg) solution will be administered. Standard monitors like ECG, Pulse oximeter , non-invasive blood pressure were connected. Patient was placed in the sitting position and subarachnoid block was given with 25G Quinckes needle using 1.5 ml of hyperbaric 0.5% levobupivacaine followed by 1.5 ml of isobaric 0.5% levobupivacaine at L3-L4 intervertebral space using a midline approach. The injection of local anaesthetic solutions will be given gradually over a period of 10-15 seconds after negative aspiration for blood and CSF accordingly. Immediately after subarachnoid block patient will be placed supine. The blinded anaesthesiologist will use the modified Bromage scale to check on the motor block every 5 minutes (1: Complete movement, 2: Unable to flex the hips, can bend the knee, 3: Unable to flex knee yet able to flex the ankle and 4: No movement). The time needed to reach Bromage 3 before surgery and regress to Bromage 0 after surgery will be recorded. Heart rate (HR), mean arterial pressure (MAP), sensory and motor blockade will be measured at baseline, 5, 10, 15, 20, 25, 30, 45, 60 and 120 minutes after the injection by the blinded anaesthesiologist. Post-operative complications will be recorded, such as hypotension (defined as MAP 65 mmHg or decrease in basal MAP by 20% and will be treated with IV fluids), bradycardia (defined as HR 50 beats/min and will be treated by IV atropine 0.02 mg/kg), shivering (will be treated by tramadol 50 mg in IV drip), nausea, vomiting (will be treated by IV ondansetron 4 mg), PDPH, discomfort. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA Grade I and II patients.
2. Patients posted for below umbilical elective surgeries.
3. Age between 18 years to 65 years.
4. BMI 17-30 kg/m2
5. Patients of all genders. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal for procedure.
2. Any bleeding disorder or patient on anticoagulants.
3. Surgeries prolonging more than 3 hrs.
4. Pregnant and lactating females.
5. Patients with failed spinal anaesthesia.
6. History of drug allergy.
7. Local infection at the injection site. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the highest level of sensory block achieved, the onset & duration of motor block achieved and the recovery from subarachnoid block given by using either 0.5% hyperbaric, 0.5% isobaric or sequential hyperbaric followed by isobaric levobupivacaine. |
1. Time of subarachnoid block administration.
2. Sensory block onset (time taken to reach T10 level).
3. Sensory block duration (2 segment regression of sensory level).
4. Motor block onset (time taken to reach modified bromage score 3).
5. Motor block duration (time taken in regression of modified bromage score to 0. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess intraoperative hemodynamics [Heart Rate(HR), Blood Pressure(BP), Mean Arterial Pressure(MAP), oxygen saturation(SpO2), Temperature]. |
At rest, 1min., 5min., 10min., 15min., 30min., 60min., 90min., 120min. |
| To assess postoperative pain score using Visual Analogue Scale (VAS) score. |
At rest, 2nd hour, 4th hour, 8th hour, 12th hour, 16th hour, 24th hour. |
| To assess the time of first rescue analgesia (when VAS score is more than 4). |
Time at which 1st analgesic was required postoperatively. |
| To assess any adverse events related to subarachnoid block. |
For 24 hrs following surgery. |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
11/06/2025 |
| 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 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
|
It is a prospective, double blind, randomised, comparative, hospital based study to be
conducted by Department of Anaesthesia, Mahatma Gandhi
Medical College & Hospital, Jaipur.
After ethical committee’s approval, informed written consent
will be obtained from all patients.
After doing all the required investigation, PAC will be performed
a day before the surgery.
Patients will be randomly divided into three groups of 35 each
with the help of computer generated randomization tables
method. All patients will be explained about the anaesthesia
technique. On
the day of surgery patients will be shifted to operation theatre and all the
monitors including pulse oximeter , ECG and non-invasive blood pressure will
be attached and baseline parameters
will be noted. Intravenous access will be obtained with 20 G cannula. A preload of 500 mL of Ringer Lactate 10 ml/kg solution will
be administered.
All
patients will be given subarachnoid block with 25G Quincke’s needle at L3-L4 intervertebral space in sitting position using a midline approach. Group A will be injected with 3 ml of hyperbaric 0.5% levobupivacaine, group B
will be injected with 3 ml of isobaric 0.5% levobupivacaine and group C will be
injected with 1.5 ml of hyperbaric 0.5% levobupivacaine followed by 1.5 ml of
isobaric 0.5% levobupivacaine. The
injection of local anaesthetic solutions will be done gradually over a period of
10-15 seconds after negative aspiration for blood and CSF accordingly.
Immediately after spinal block all the patients will be placed supine.
The
blinded anaesthesiologist
will
use the modified Bromage
scale to check on the motor block every 5 minutes. The time needed to reach Bromage
3 before surgery and regress to Bromage
0 after surgery will be recorded. Hemodynamic parameters, sensory and motor blockade will be
measured at baseline, 5, 10, 15, 20, 25, 30, 45, 60 and 120 minutes after the
injection by the blinded anaesthesiologist.
Post-operative complications of subarachnoid block will
be recorded and treated accordingly.
|