A Phase 4 interventional study of spinal anesthesia in Spinal Anesthesia, sponsored by Tribhuvan University, Nepal. Completed at 1 site in Nepal. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Tribhuvan University, Nepal · Phase 4, Interventional, and Treatment
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.
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.
Tribhuvan University, Nepal is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
bupivacaine 0.5% heavy, 3ml
Procedure: spinal anesthesia
ropivacaine 0.75% isobaric, 3ml
Procedure: spinal anesthesia
Spinal anesthesia with bupivacaine 0.5% or ropivacaine 0.75%
duration of motor block
duration of motor block among either drug
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 sensory block
comparison of 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
pulse rate taken at 0,5,10,20, 30 and every 15 minutes thereafter till the end of the surgery.
Time frame: 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.
Time frame: From the time of first examination for any sensory block till the end of surgery.
Plan to share: Yes — All data.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: 2026-09-21 till 2030-09-21
Access criteria: Everyone
No publications or documents are linked to this record.
Ran from Dec 2018 to primary completion in Oct 2019, 9 months.
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Tribhuvan University, Nepal