Dexmedetomidine Versus Nalbuphine as an Adjuvant to Intrathecal Bupivacaine (Intrathecal)

Dexmedetomidine Versus Nalbuphine as an Adjuvant to Intrathecal Bupivacaine in Lower Limb Surgeries

Spinal anesthesia is the most consistent block for lower abdomen and lower limb surgical procedures. Over years many drugs have been used as an additive to spinal anesthesia in order to prolong the duration of action and to provide adequate postoperative analgesia.

Dexmedetomidine, a highly selective α2 agonist is rapidly emerging as the choice of additive to spinal anesthesia in view of its property to provide analgesia however, it may be associated with bradycardia which may affect the hemodynamic stability.

Nalbuphine is an opioid with agonist actions in the kappa receptor and antagonist actions in the mu receptor, it produces analgesia and sedation and lesser side effects through antagonism at the mu receptor but, it could be associated with some side effects as: dizziness, bradycardia, nausea, vomiting, and pruritus and may be associated with respiratory depression.

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Nalbuphine

Detailed Description

This prospective, double blinded, randomized, controlled study will be held to compare Nalbuphine versus Dexmedetomidine as adjuvants to intrathecal Bupivacaine in spinal anesthesia in patients undergoing lower limb orthopedic surgeries

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura
    • El Dakahlia, Mansoura, Egypt, 35511
      • Mansoura University-Emergency hospital-ICU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 20 and 60 years.
• Both genders.
• Patients scheduled for lower limb orthopedic surgeries under spinal anesthesia.
• American society of anesthesiologists (ASA) class I or II.

Exclusion Criteria:

• Patient refusal.
• Age <20 or >60 years.
• Contraindications to spinal anesthesia (e.g. bleeding diathesis, spinal cord deformities, infection at injection site).
• History of allergy to any of the study medications.
• Cases with severe cardiac, renal, or hepatic disease.
• American society of anesthesiologists (ASA) class III, IV.
• Patient on regular analgesics or opioid abuse.
• Patient with peripheral neuropathy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Bupivacaine group (B gp); Patients will receive 2.5 ml hyperbaric bupivacaine (0.5%) plus 0.5 ml normal saline
Active Comparator: Bupivacaine-Dexmedetomidine group (BD gp); Patients will receive 2.5 mL hyperbaric bupivacaine (0.5%) plus 10 µg Dexmedetomidine in 0.5 mL normal saline	Drug: Dexmedetomidine; patients who will receive 2.5 mL hyperbaric bupivacaine (0.5%) plus Dexmedetomidine (10 µg in 0.5 mL normal saline)
Active Comparator: Bupivacaine-Nalbuphine group (BN gp); Patients will receive 2.5 mL hyperbaric bupivacaine (0.5%) plus 1 mg Nalbuphine in 0.5 mL normal saline	Drug: Nalbuphine; patients who will receive 2.5 mL hyperbaric bupivacaine (0.5%) plus Nalbuphine (1 mg in 0.5 mL normal saline)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The post-operative analgesic duration	during the first 24 postoperative hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset of sensory block	from intrathecal injection till sensory block grade 2 at T10	After intrathecal injection up to 15 minutes
Onset of motor block	from intrathecal injection till reach Bromage scale 3	After intrathecal injection up to 15 minutes
Heart rate (HR)	beat per minute	Every 5 minutes after spinal injection for the first 30 minutes, and then every 15 minutes till the end of surgery
Mean arterial pressure (MAP)	mmHg	Every 5 minutes after spinal injection for the first 30 minutes, and then every 15 minutes till the end of surgery
Hypotension will be considered if there was 25% decrease below the baseline for Mean arterial pressure (MAP)	mmHg	every 5 minutes after spinal injection for the first 30 minutes, then every 15 minutes till the end of surgery and every 30 minutes for the first 6 hours postoperatively
Bradycardia will be considered if the heart rate is less than 50 beats/min	beat per minute	every 5 minutes after spinal injection for the first 30 minutes, then every 15 minutes till the end of surgery and every 30 minutes for the first 6 hours postoperatively
postoperative pain	visual analogue scale (VAS) marked from 0-10 (where 0 = no pain and 10 = worst pain imaginable)	at 0, 2, 4, 6, 8,12,18 and 24 hours postoperatively
side effects as Vomiting, Nausea, pruritus, shivering	incidence	Intraoperatively and for the first 24 hours postoperatively
sedation	via Ramsay scale [1= Patient is anxious and agitated or restless, or both, 2= Patient is co-operative, oriented, and tranquil, 3= Patient responds to commands only, 4= Patient exhibits brisk response to light glabellar tap or loud auditory stimulus, 5= Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus and 6=Patient exhibits no response]	at 0, 2, 4, 6, 8,12,18 and 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2022
• Primary Completion (Actual): January 30, 2024
• Study Completion (Actual): March 12, 2024

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 20, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Dexmedetomidine; Nalbuphine
• Other Study ID Numbers: Dexmed+Nalbuph

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No