Comparision of two drugs used in spinal anaesthesia named as hyperbaric Levobupivacaine (fixed dose combination) and Fentanyl versus hyperbaric Levobupivacaine (reconstituted ) and Fentanyl in patients undergoing surgeries below level of umbilicus

Not yet recruiting

• Conditions: Unspecified injury of abdomen, lower back, pelvis and external genitals, (2) ICD-10 Condition: O||Medical and Surgical,

• Registration Number: CTRI/2023/02/049684
• Lead Sponsor: Teerthanker Mahaveer Medical college, Moradabad, Uttar pradesh

Brief Summary

This study is planned in context that hyperbaric Levobupivacaine ( fixed dose combination) is recently introduced in clinical use and there are limited number of comparative clinical studies available to compare the sensory /motor block efficacy , hemodynamic profile and complication of fixed dose hyperbaric levobupivacaine vs fixed dose hyperbaric bupivacaine.

The primary limitation of earlier comparative studies is use of mixed dose hyperbaric Levobupivacaine because hyperbaric property is due to addition of dextrose in isobaric levobupivacaine.



so, the difference in the spinal charactiestics may have been in part related to the difference in baracity and dextrose concentration as well as constitution of hyperbaric solution..

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-15
• Last Update Posted: 2023-09-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Adult patients of the American Society of Anesthesiologists physical status I and II, scheduled to undergo infra-umbilical surgery under spinal anaesthesia will be select Informed consent.

Exclusion Criteria

• Patients with uncontrolled hypertension, Neurologic disease, left ventricular dysfunction and coagulation Disorders.
• Pregnancy Hypersensitivity to amide local anesthetics.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Each participant in the study will be assessed for following Primary outcome parameters are as follows :-	1.Onset of sensory block (min.) -loss of sensation to T-8 level. | 2.Duration of sensory block (min.)-complete regression assessed at 3 minutes first 15 min, 5 min for next 30 min, at every 30 min up to 480 minutes. | 3.Onset time of motor block (min.) | 4.Total duration of motor block (min.) | 5.Duration of analgesia (min.):- from onset of sensory block to first request for rescue analgesia | Time points data analysis:-1st at 6th month from onset , 2nd at 1 year and 3rd and final at end
1.Onset of sensory block (min.)	1.Onset of sensory block (min.) -loss of sensation to T-8 level. | 2.Duration of sensory block (min.)-complete regression assessed at 3 minutes first 15 min, 5 min for next 30 min, at every 30 min up to 480 minutes. | 3.Onset time of motor block (min.) | 4.Total duration of motor block (min.) | 5.Duration of analgesia (min.):- from onset of sensory block to first request for rescue analgesia | Time points data analysis:-1st at 6th month from onset , 2nd at 1 year and 3rd and final at end
2.Duration of sensory block (min.)	1.Onset of sensory block (min.) -loss of sensation to T-8 level. | 2.Duration of sensory block (min.)-complete regression assessed at 3 minutes first 15 min, 5 min for next 30 min, at every 30 min up to 480 minutes. | 3.Onset time of motor block (min.) | 4.Total duration of motor block (min.) | 5.Duration of analgesia (min.):- from onset of sensory block to first request for rescue analgesia | Time points data analysis:-1st at 6th month from onset , 2nd at 1 year and 3rd and final at end
5.Duration of analgesia (min.)	1.Onset of sensory block (min.) -loss of sensation to T-8 level. | 2.Duration of sensory block (min.)-complete regression assessed at 3 minutes first 15 min, 5 min for next 30 min, at every 30 min up to 480 minutes. | 3.Onset time of motor block (min.) | 4.Total duration of motor block (min.) | 5.Duration of analgesia (min.):- from onset of sensory block to first request for rescue analgesia | Time points data analysis:-1st at 6th month from onset , 2nd at 1 year and 3rd and final at end
3.Onset time of motor block (min.)	1.Onset of sensory block (min.) -loss of sensation to T-8 level. | 2.Duration of sensory block (min.)-complete regression assessed at 3 minutes first 15 min, 5 min for next 30 min, at every 30 min up to 480 minutes. | 3.Onset time of motor block (min.) | 4.Total duration of motor block (min.) | 5.Duration of analgesia (min.):- from onset of sensory block to first request for rescue analgesia | Time points data analysis:-1st at 6th month from onset , 2nd at 1 year and 3rd and final at end
4.Total duration of motor block (min.)	1.Onset of sensory block (min.) -loss of sensation to T-8 level. | 2.Duration of sensory block (min.)-complete regression assessed at 3 minutes first 15 min, 5 min for next 30 min, at every 30 min up to 480 minutes. | 3.Onset time of motor block (min.) | 4.Total duration of motor block (min.) | 5.Duration of analgesia (min.):- from onset of sensory block to first request for rescue analgesia | Time points data analysis:-1st at 6th month from onset , 2nd at 1 year and 3rd and final at end

Secondary Outcome Measures

Name	Time	Method
Hemodynamics (HR, RR, SBP, DBP, MAP, SP02)Vitals

Trial Locations

Locations (1)

Teerthanker Mahaveer Medical college, Moradabad, Uttar pradesh; 🇮🇳 Moradabad, UTTAR PRADESH, India

Teerthanker Mahaveer Medical college, Moradabad, Uttar pradesh

🇮🇳Moradabad, UTTAR PRADESH, India

Dr vivek sharma

Principal investigator

9452038393

officer.sharma@gmail.com