Clinical trial NCT05041270: Epidural Nalbuphine Versus Dexmedetomidine as Adjuvants to Bupivacaine in Lower Limb Surgeries
Official title: Epidural Nalbuphine Versus Dexmedetomidine as Adjuvants to Bupivacaine in Lower Limb Surgeries Under Combined Spinal-epidural Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Limb Surgeries
Keywords: Epidural Nalbuphine
Epidural Dexmedetomidine
combined spinal-epidural anesthesia
lower limb surgeries
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2021-09-13
Enrollment: 23
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be divided randomly by a computer-generated randomization table into three equal groups
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Surgical patients need adequate and effective intraoperative anesthesia and postoperative analgesia. Neuroaxial block including lower limb spinal and epidural blocks have a long history of effective anesthesia and lower limb pain relief. Spinal anesthesia is a simple method requiring small dose of local anesthetic agent to give immediate and effective sensory and motor block. But one of its major side effects is hypotension and difficulty in controlling the level of the block \[1\]. Meanwhile, epidural anesthesia is a safe, well-practiced, not expensive neuroaxial block technique that provides intraoperative anesthesia and postoperative analgesia. So, the combined spinal epidural block (CSE) aims to achieve intense sensory and motor anesthesia and prolong the duration of analgesia intraoperative extending to postoperative period \[2\].

Neuroaxial anesthesia and analgesia provide perfect analgesic effect by inhibiting nociceptive transmission from peripheral to central neuronal system, but this advantage limited by short half-life of the current local anesthetics. Bupivacaine is a local anesthetic which belongs to amide group of anesthetic agents that has been widely used for local infiltration, peripheral nerve block, spinal and epidural anesthesia and despite relatively long duration of action, still has insufficient time for postoperative analgesia \[3\].

Several neuroaxial adjuvants such as (opioids, dexamethasone, magnesium sulphate, midazolam and dexmedetomidine) can be added to local anesthetics to prolong its duration of anesthesia and decrease the dose requirement of local anesthetics \[4\].

Nalbuphine, a derivative of 14-hydroxy morphine is a strong analgesic with mixed kappa agonist and µ antagonist properties. Its potency is equal to morphine, but exhibits a ceiling effect on respiratory depression. It has the potential to maintain and enhance µ-opioid based anesthesia while simultaneously mitigating the µ-opioid side effects \[5\].

Dexmedetomidine is an imidazole compound. It is a highly selective α-2 adrenergic agonist with an affinity 8 times more specific when compared to clonidine. It has sedative, sympatholytic and analgesic effects that blunt cardiovascular responses both intraoperative and in the perioperative period. Patients remain calm and sedated when undisturbed but arouse readily with stimulation \[6\]. Dexmedetomidine causes manageable hypotension and bradycardia, but the striking feature of this drug is the lack of opioid-related adverse effects like respiratory depression, pruritis, nausea, and vomiting \[7\].

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.

Primary outcomes:
measure: Duration of epidural analgesia
timeFrame: within 24 hour postoperative
measure: Maximum level of sensory blockade
timeFrame: after 30 min of administering the local anesthetic in the epidural space
Secondary outcomes:
measure: number of top up doses required
timeFrame: within 24 hour postoperative
measure: assessment of changes in patient's level of sedation
timeFrame: Sedation scores will be recorded just before the initiation and 2 hours postoperatively
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: faculty of medicine, Zagazig university
state: Elsharqya
Study officials:
affiliation: Faculty of medicine, zagazig university, Zagazig, Elsharqya, Egypt, 44519
name: Howaida A Kamal, MD
role: STUDY_DIRECTOR
References:
citation: Shruthi AH, Sudheesh K, Nethra SS, Raghavendra Rao RS, Devika Rani D. THE EFFECT OF A SINGLE DOSE OF MAGNESIUM SULPHATE AS AN ADJUVANT TO EPIDURAL BUPIVACAINE FOR INFRAUMBILICAL SURGERIES: A PROSPECTIVE DOUBLE-BLIND, RANDOMIZED CONTROL TRIAL. Middle East J Anaesthesiol. 2016 Feb;23(4):449-55.
citation: Chatrath V, Attri JP, Bala A, Khetarpal R, Ahuja D, Kaur S. Epidural nalbuphine for postoperative analgesia in orthopedic surgery. Anesth Essays Res. 2015 Sep-Dec;9(3):326-30. doi: 10.4103/0259-1162.158004.
citation: Gupta K, Rastogi B, Gupta PK, Singh I, Bansal M, Tyagi V. Intrathecal nalbuphine versus intrathecal fentanyl as adjuvant to 0.5% hyperbaric bupivacaine for orthopedic surgery of lower limbs under subarachnoid block: A comparative evaluation. Indian J Pain. 2016; 30:90-5.
citation: Chiruvella S, Donthu B, Nallam SR, Salla DB. Postoperative Analgesia with Epidural Dexmedetomidine Compared with Clonidine following Total Abdominal Hysterectomies: A Prospective Double-blind Randomized Trial. Anesth Essays Res. 2018 Jan-Mar;12(1):103-108. doi: 10.4103/aer.AER_207_17.
citation: Soliman AAM, Melika ASM. Epidural bupivacaine and dexmedetomidine versus bupivacaine and opioids for lower vascular surgery. J Med Sci Res. 2018; 1:158-63.
citation: Paul A, Nathroy A, Paul T. A comparative study of dexmedetomidine and fentanyl as an adjuvant to epidural bupivacaine in lower limb surgeries. J Med Sci. 2017; 37:221-6.