Clinical trial NCT05347173: Dexmedetomidine Versus Nalbuphine as an Adjuvant to Intrathecal Bupivacaine
Official title: Dexmedetomidine Versus Nalbuphine as an Adjuvant to Intrathecal Bupivacaine in Lower Limb Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Via the sealed envelope method; the patients will be randomly assigned to three equal groups according to the administration of adjuvant to intrathecal Bupivacaine and its dose;

* Bupivacaine group (B gp) will include patients who will receive 2.5 ml hyperbaric bupivacaine (0.5%) +0.5 ml normal saline.
* Bupivacaine-Dexmedetomidine group (BDgp) will include patients who will receive 2.5 ml hyperbaric bupivacaine (0.5%) plus Dexmedetomidine (10 µg in 0.5 ml normal saline).
* Bupivacaine-Nalbuphine group (BN gp) will include patients who will receive 2.5 ml hyperbaric bupivacaine (0.5%) plus Nalbuphine (1 mg in 0.5ml normal saline).
Primary purpose: PREVENTION

Brief summary: 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: The post-operative analgesic duration
timeFrame: during the first 24 postoperative hours
Secondary outcomes:
measure: Onset of sensory block
timeFrame: After intrathecal injection up to 15 minutes
measure: Onset of motor block
timeFrame: After intrathecal injection up to 15 minutes
measure: Heart rate (HR)
timeFrame: Every 5 minutes after spinal injection for the first 30 minutes, and then every 15 minutes till the end of surgery
measure: Mean arterial pressure (MAP)
timeFrame: Every 5 minutes after spinal injection for the first 30 minutes, and then every 15 minutes till the end of surgery
measure: Hypotension will be considered if there was 25% decrease below the baseline for Mean arterial pressure (MAP)
timeFrame: 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
measure: Bradycardia will be considered if the heart rate is less than 50 beats/min
timeFrame: 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
measure: postoperative pain
timeFrame: at 0, 2, 4, 6, 8,12,18 and 24 hours postoperatively
measure: side effects as Vomiting, Nausea, pruritus, shivering
timeFrame: Intraoperatively and for the first 24 hours postoperatively
measure: sedation
timeFrame: at 0, 2, 4, 6, 8,12,18 and 24 hours postoperatively
Other outcomes:
Locations:
city: El Dakahlia
country: Egypt
facility: Mansoura University-Emergency hospital-ICU
state: Mansoura
Study officials:
References: