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NCT Number: NCT07777055

Comparison of Efficacy of 0.5% Hyperbaric Bupivacaine and 0.75%Isobaric Ropivacaine for Spinal Anaeshesia

Spinal anaesthesia is a preferred technique used for lower abdominal and lower limb surgeries as it provides faster and profound sensory and motor blockade. Bupivacaine is the most commonly used local anaesthetic in spinal anaesthesia. Earlier studies have suggested that Ropivacaine causes shorter duration of motor blockade and provides early ambulation to the patient. The aim of this double- blinded, prospective, randomized controlled study was to compare the effect of 0.5% Hyperbaric Bupivacaine and 0.75% Isobaric Ropivacaine for spinal anaesthesia.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institute of Medicine

Kathmandu, Bagmati, Nepal

About this study

Regional anaesthesia is a well established anaesthetic technique to provide anaesthesia for lower abdominal and lower limb surgeries.Spinal anaesthesia is one of the regional anaesthesia techniques where local anaesthesia is injected into lumbar subarachnoid space to anaesthetize nerves that exit the spinal cord. Spinal anaesthesia is most commonly used for anaesthesia and analgesia for a variety of lower extremity, abdominal, pelvic and perineal procedures.

Spinal anaesthesia is widely used by anaesthesiologists due to many advantages like quick onset, dense anaesthesia with minimal side effects compared to general anaesthesia. It has become popular because of the simplicity, less operative blood loss, and minimal preoperative preparation. Motor block from spinal anaesthesia beyond the duration of surgery is undesirable. So, spinal anaesthesia is not preferred in ambulatory settings. Various local anaesthetics have been used for spinal anaesthesia, starting with cocaine way back in 1898. Hyperbaric Bupivacaine is a commonly used drug for spinal anaesthesia.

The acute and most severe adverse effects of local anaesthetics are cardiovascular and CNS toxicity. These are usually because of accidental intravascular injection and pronounced overdose. These adverse effects have prompted a search for drugs with lesser toxicity. This led to the introduction of newer local anaesthetics like Ropivacaine.

Ropivacaine, the S - enantiomer of Propivacaine is less lipophilic than Bupivacaine. This property is associated with a decreased potential for CNS toxicity and cardiotoxicity. Hence, it has a better safety profile.

Ropivacaine is similar to Bupivacaine in onset, quality, duration of sensory block and it produces lesser duration of motor blockade. Ropivacaine has shown to be effective and comparable haemodynamic effect in spinal anaesthesia compared to Bupivacaine in lower abdominal and lower limb surgeries.

Ropivacaine may be useful in day care surgeries and in surgeries where early ambulation is required for the patients.

In the past, Lignocaine was used for spinal anaesthesia. However, it was associated with transient neurological symptoms and became less popular.

Both Bupivacaine and Ropivacaine are being used in surgeries like transurethral replacement of prostate, lower abdominal and lower limb surgeries,cesarean section, hip and knee replacement surgery.

There are very few studies comparing intrathecal use of equal volume of Isobaric Ropivacaine and Hyperbaric Bupivacaine and comparing their efficacy and duration of motor blockade.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • AGE: >18 years>65years
  • All ASA I and II patients
  • Undergoing elective orthopaedic surgeries
  • No contraindications for spinal anesthesia

Exclusion criteria

  • pregnancy,
  • obesity,
  • ASA III and IV,
  • emergency surgeries.

Treatment and study plan

Spinal anesthesia

Procedure

Spinal anesthesia with bupivacaine 0.5% or ropivacaine 0.75%

Primary outcomes

  1. duration of motor block

    Time frame: from the time of first motor block confirmation on examination to the complete regression of motor block (Modified Bromage scale 6 on examination). Data taken at 0,10,15 minutes and thereafter every 30 minutes till full recovery.

    duration of motor block among either drug

Secondary outcomes

  1. duration of sensory block

    Time frame: from the time of first examination for any sensory block till two segment regression of sensory block. Sensory block was tested at 0,5,10,20 and every 10 minutes thereafter till 2 segment regression from the first established highest sensory level.

    comparison of duration of sensory block

  2. Pulse rate

    Time frame: From the time of first examination for any sensory block till the end of surgery.

    pulse rate taken at 0,5,10,20, 30 and every 15 minutes thereafter till the end of the surgery.

  3. Blood Pressure

    Time frame: From the time of first examination for any sensory block till the end of surgery.

    Systolic, diastolic and mean blood pressure will be taken at 0,5,10,20, 30 and every 15 minutes thereafter till the end of the surgery.

Sponsors and collaborators

Lead sponsor

Tribhuvan University, Nepal

Other

Registry information

Official study title

Comparison of Efficacy of 0.5%Hyperbaric Bupivacaine and 0.75% Isobaric Ropivacaine for Spinal Anaeshesia

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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