Spinal AnesthesiaPhase 4NCT07777055
Comparison of Efficacy of 0.5% Hyperbaric Bupivacaine and 0.75%Isobaric Ropivacaine for Spinal Anaeshesia
A Phase 4 study testing spinal anesthesia in people with Spinal Anesthesia, run by Tribhuvan University, Nepal at 1 site in Nepal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Anesthesia
- What is being tested?
- spinal anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteNepal
- Study dates
- 28 Dec 2018to 1 Nov 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AGE: >18 years>65years
- All ASA I and II patients
- Undergoing elective orthopaedic surgeries
- No contraindications for spinal anesthesia
Who cannot join
- pregnancy,
- obesity,
- ASA III and IV,
- emergency surgeries.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Spinal Anesthesia
- Being tested
- spinal anesthesia
- Keywords
- Spinal anesthesia ,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anesthesiaProcedure or surgery
Spinal anesthesia with bupivacaine 0.5% or ropivacaine 0.75%
| Study group | Role | What they receive |
|---|---|---|
| spinal anesthesia with bupivacaine | Active comparator | bupivacaine 0.5% heavy, 3ml Receives: Procedure: spinal anesthesia |
| spinal anesthesia with ropivacaine | Active comparator | ropivacaine 0.75% isobaric, 3ml Receives: Procedure: spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of motor block
duration of motor block among either drug
Measured: 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.
Secondary outcomes (3)
duration of sensory block
comparison of duration of sensory block
Measured: 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.
Pulse rate
pulse rate taken at 0,5,10,20, 30 and every 15 minutes thereafter till the end of the surgery.
Measured: From the time of first examination for any sensory block till the end of surgery.
Blood Pressure
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.
Measured: From the time of first examination for any sensory block till the end of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start28 Dec 2018
- Primary completion1 Oct 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tribhuvan University, Nepal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prashant Bidari, Tribhuvan University, Nepal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777055
- Sponsor's protocol ID
- 327/075/076
- Status last verified
- Aug 2026
- First submitted
- 10 Feb 2020
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of 0.5%Hyperbaric Bupivacaine and 0.75% Isobaric Ropivacaine for Spinal Anaeshesia
- ClinicalTrials.gov ID
- NCT07777055
- Acronym / sponsor ID
- 327/075/076
- Conditions
- Spinal Anesthesia
- Keywords
- Spinal anesthesia ,
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Tribhuvan University, NepalUniversity, hospital or other
- Study start
- 28 Dec 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spinal anesthesia with bupivacaine | Active comparator | Procedure: spinal anesthesiabupivacaine 0.5% heavy, 3ml |
| spinal anesthesia with ropivacaine | Active comparator | Procedure: spinal anesthesiaropivacaine 0.75% isobaric, 3ml |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- AGE: >18 years>65years
- All ASA I and II patients
- Undergoing elective orthopaedic surgeries
- No contraindications for spinal anesthesia
Key exclusion criteria (4 listed)
- pregnancy,
- obesity,
- ASA III and IV,
- emergency surgeries.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal anesthesiaSpinal anesthesia with bupivacaine 0.5% or ropivacaine 0.75% | Procedure or surgery | spinal anesthesia with bupivacaine, spinal anesthesia with ropivacaine |
Primary outcome
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
3 secondary outcomes
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.
Pulse rate
Time frame: From the time of first examination for any sensory block till the end of surgery.
Blood Pressure
Time frame: From the time of first examination for any sensory block till the end of surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: Yes. All data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing spinal anesthesia in people with Spinal Anesthesia, run by Tribhuvan University, Nepal at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.