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Clinical Trials/CTRI/2022/10/046588
CTRI/2022/10/046588Not yet recruitingNot Applicable

Comparison of intrathecal 0.5% hyperbaric bupivacaine plus fentanyl with 0.75% hyperbaric ropivacaine plus fentanyl in lower limb and lower abdominal surgeries

ESIC Medical College and PGIMSR KK Nagar1 site in 1 country60 target enrollmentStarted: October 27, 2022Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Comparison of the duration of motor block between the two drugs

Study Overview

Brief Summary

Bupivacaine, is an amino-amide compound, was synthesized and introduced into the clinical practice in 1963 and proved to be a very effective long-acting local anaesthetic agent. In 1979, Albright drew attention to the dangers of the longer acting local anaesthetic agents, bupivacaine and etidocaine, in case they gained accidental intravascular access, resulting in re-entrant arrhythmias and cardiac depression, sometimes culminating in cardiac arrest. These shortcomings, of this otherwise novel local anaesthetic, resulted in the development of a newer anaesthetic agent ropivacaine.

Ropivacaine and levobupivacaine a new amino-amide local anaesthetic agents, are similar in chemical structure to bupivacaine. Extensive clinical data has shown that ropivacaine is effective and produces hemodynamic stability for regional anaesthetic techniques such as epidural and brachial plexus block.

Adjutants like opioids have shown to improve the analgesic duration of post spinal anaesthesia because of their motor sparing property thereby improving the quality and success of anaesthesia. Fentanyl is the most common opioid which is extensively used as an adjuvant to hyperbaric bupivacaine for enhancement of analgesia without increasing the depth of motor and sympathetic block.

Hyperbaric ropivacaine with fentanyl has been little studied in intrathecal anaesthesia However, this hyperbaric ropivacaine were isobaric preparations. Due to that the spread of drugs could not be controlled by adjusting the positions. Currently ropivacaine has been introduced as a hyperbaric ropivacaine. Studies comparing hyperbaric ropivacaine with other drugs are very few

Hyperbaric Ropivacaine molecule drug was launched by Neon laboratories first in india followed by other countries on 12.11.2021. No other manufactures available till now for this drug. So, the drug which was used by the previous studies was not hyperbaric ropivacaine. They have used isobaric ropivacaine and mixed with dextrose which is not a original drug molecule used by us.

This hyperbaric ropivacaine molecule which we have used in the original molecule by the manufacture which is approved by DGCI on 13.08.2021.

Only one or two studies carried out in Indian Population they rest or done in western countries. The results from this study will be more valid and relevant to practising anaesthesiologists who will have access to this DGCI approved Hyperbaric Ropivacaine. This can be compared with the previous studies to see if the results are same or different.

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Hence this study is conceptualized to compare the effects of block characterises such as duration of action and hemodynamic stability of hyperbaric ropivacaine plus fentanyl in spinal anaesthesia and to compare it with hyperbaric bupivacaine plus fentanyl in lower limb and lower abdominal surgeries.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1Patient with written informed consent 2ASA physical status of I and II 3Patient Posted for lower limb and lower abdominal surgeries 4Age groups 18- 60 years.

Exclusion Criteria

  • 1Patient refusal 2Known allergy to local anaesthetics 3Gross spinal deformities 4Pregnancy and Lactating females 5Contraindications to regional anaesthesia (bleeding diathesis, use of any anti-coagulants, infection at the site of injection).

Outcomes

Primary Outcomes

Comparison of the duration of motor block between the two drugs

Time Frame: At 2 hours, 3 hours,4 hours,5 hours,6 hours

Secondary Outcomes

  • Time to onset of sensory block(Every 1 min)
  • Duration of sensory block(Every 15 min)
  • Time of motor block(Every 15 min)
  • Hemodynamic parameters(Every 15min)

Investigators

Sponsor
ESIC Medical College and PGIMSR KK Nagar
Sponsor Class
Government medical college

Study Sites (1)

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