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Comparison between hyperbaric Ropivacaine and hyperbaric Bupivacaine in patients undergoing inguinal and perineal surgeries under spinal anaesthesia.

Not yet recruiting
Conditions
Medical and Surgical,
Registration Number
CTRI/2023/02/050035
Lead Sponsor
Dr D Y Patil Medical college Hospital and Research Centre Pune
Brief Summary

Spinal anesthesia for most lower abdominal and lower limb surgeries are carried out using injection bupivacaine heavy, which produces effective autonomic, sensory and motor blockade of the dermatomes above and below the level of intrathecal injection. However, bupivacaine is a long-acting agents with increased risks of re-entrant arrhythmias and cardiac depression which lead to the development of ropivacaine, which has increased threshold in terms of risk of CVS or CNS toxicity unlike bupivacaine. Also, with the advent of day care surgical procedures and early postoperative patient mobilization to aid in better prognostic outcome, using a long-acting agent such as bupivacaine becomes a deterrent. Additionally, the use of hyperbaric ropivacaine for subarachnoid blockade is still in nascent stages in our country. We require more studies to evaluate and assess the degree of effective ascend as well as descend of sensory and motor block with hyperbaric ropivacaine in order to encourage more clinical use of this drug and help us take a step towards better patient mobilization and care postoperatively for routine day care surgeries.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
30
Inclusion Criteria
  • Patients undergoing inguinal and perineal surgeries under spinal anesthesia.
  • Hemodynamically stable patients with all routine investigations within normal limits with no co-morbidities.
  • Patients who are not on any cardiac related drugs.
  • Availability of informed consent.
Exclusion Criteria
  • Patients with ASA physical status 3 or more.
  • Patients below 18 years and above 60 years of age.
  • Patients posted for emergency procedures.
  • Patients with major neurological, cardiac, respiratory, metabolic, renal, hepatic disease or any coagulation abnormalities.
  • Patients contraindicated for spinal anesthesia.
  • Patients with known allergies to the study drugs.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Time taken for the onset of sensory block followed by2 minutes to 15 minutes
Time taken to T8 level sensory blockade post subarachnoid block with either injection bupivacaine heavy or injection ropivacaine heavy.2 minutes to 15 minutes
Secondary Outcome Measures
NameTimeMethod
Onset and duration of motor blockade2 minutes to 150 minutes
Duration of sensory blockade150 minutes
Intraoperative hemodynamic parameters like heart rate, blood pressure2 minutes to 150 minutes
Time of first micuritionAt 120 to 150 minutes post subarachnoid block
5.To observe for any incidence of adverse events and for the need of general anesthesia (GA) supplementation.2 to 20 minutes

Trial Locations

Locations (1)

DR DY PATIL MEDICAL COLLEGE PUNE

🇮🇳

Pune, MAHARASHTRA, India

DR DY PATIL MEDICAL COLLEGE PUNE
🇮🇳Pune, MAHARASHTRA, India
Dr Bhavini Shah
Principal investigator
09850829994
drbhavinishah71@gmail.com

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