Clinical trial

Epidural Nalbuphine Versus Dexmedetomidine as Adjuvants to Bupivacaine in Lower Limb Surgeries Under Combined Spinal-epidural Anesthesia

Name

16-8-2021

Description

Combined spinal epidural anesthesia (CSE) with bupivacaine alone is not sufficient to cover pain sequel during lower limb surgeries. Previous studies used addition of either Nalbuphine or dexmedetomidine to bupivacaine in epidural anesthesia giving a good result in pain control. In this study the investigators will evaluate and compare the addition of either Nalbuphine or dexmedetomidine to bupivacaine in epidural anesthesia to evaluate the analgesic efficacy of either drug.

Trial arms

Trial start

2021-10-01

Estimated PCD

2022-04-30

Trial end

2022-05-15

Status

Completed

Treatment

normal saline

Surgery will be started under spinal anesthesia. When sensory block regress to T12 dermatome Epidural bolus dose will be given epidural bolus dose of 12ml (10ml 0.25% bupivacaine + 2ml normal saline) The onset of sensory blockade injected epiduraly with maximal cephalic spread will be assessed by bilateral pinprick method along the midclavicular line, every 5 min for 30 min and then every 30 min. top up dose of 8ml will be given postoperative (6ml 0.25% bupivacaine + 2ml normal saline).

Arms:

control group

Dexmedetomidine

Surgery will be started under spinal anesthesia. When sensory block regress to T12 dermatome Epidural bolus dose will be given epidural bolus dose of 12ml (10ml 0.25% bupivacaine + 100µg dexmedetomidine in 2ml volume) The onset of sensory blockade injected epiduraly with maximal cephalic spread will be assessed by bilateral pinprick method along the midclavicular line, every 5 min for 30 min and then every 30 min. top up dose of 8ml will be given postoperative (6ml 0.25% bupivacaine + 20µg dexmedetomidine in 2ml volume).

Arms:

dexmedetomidine group

Nalbuphine

Surgery will be started under spinal anesthesia. When sensory block regress to T12 dermatome Epidural bolus dose will be given epidural bolus dose of 12ml (10ml 0.25% bupivacaine + 10mg nalbuphine in 2ml volume) The onset of sensory blockade injected epiduraly with maximal cephalic spread will be assessed by bilateral pinprick method along the midclavicular line, every 5 min for 30 min and then every 30 min. top up dose of 8ml will be given postoperative (6ml 0.25% bupivacaine + 2mg nalbuphine in 2ml volume).

Arms:

nalbuphine group

Size

Primary endpoint

Duration of epidural analgesia

within 24 hour postoperative

Maximum level of sensory blockade

after 30 min of administering the local anesthetic in the epidural space

Eligibility criteria

Inclusion Criteria: * patient acceptance. * BMI 25-29.9 kg/m2. * ASA I and ASA II. * Scheduled for elective lower limb orthopedic surgeries under (CSE) block. Exclusion Criteria: * Patient with known allergy to study drugs, * Patients suffering from severe chronic diseases (cardiac, renal, hepatic and neurological or diabetes), * Patients with infection at the site of spinal-epidural block, * Drug addict patients, * Patients on long term steroid therapy, * Patients with abnormalities in vertebral spine, * Mentally retarded or uncooperative patients, * Patients receive anti-coagulant therapy or suspected coagulopathy.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The patients will be divided randomly by a computer-generated randomization table into three equal groups', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'triple blinded (patient, anesthesiologist in the operating room and outcomes assessor)', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 23, 'type': 'ACTUAL'}}

Updated at

2023-05-12

1 organization

2 products

1 drug

1 indication

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Product