Epidural Nalbuphine Versus Dexmedetomidine as Adjuvants to Bupivacaine in Lower Limb Surgeries

NCT ID: NCT05041270

Last Updated: 2023-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2022-05-15

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].

Conditions

Lower Limb Surgeries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

control group

patient will be given epidural bolus dose of 12ml (10ml 0.25% bupivacaine + 2ml normal saline), top up dose of 8ml will be given postoperative (6ml 0.25% bupivacaine + 2ml normal saline).

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: DRUG

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).

dexmedetomidine group

patient will be given epidural bolus dose of 12ml (10ml 0.25% bupivacaine + 100µg dexmedetomidine in 2ml volume), top up dose of 8ml will be given postoperative (6ml 0.25% bupivacaine + 20µg dexmedetomidine in 2ml volume)

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

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).

nalbuphine group

patient will be given epidural bolus dose of 12ml (10ml 0.25% bupivacaine + 10mg nalbuphine in 2ml volume), top up dose of 8ml will be given postoperative (6ml 0.25% bupivacaine + 2mg nalbuphine in 2ml volume)

Group Type: ACTIVE_COMPARATOR

Nalbuphine

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

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).

Intervention Type: DRUG

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).

Intervention Type: DRUG

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Rehab Abd-Allah Wahdan

lecturer of anesthesia and surgical intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Howaida A Kamal, MD

Role: STUDY_DIRECTOR

Faculty of medicine, zagazig university, Zagazig, Elsharqya, Egypt, 44519

Locations

faculty of medicine, Zagazig university

Zagazig, Elsharqya, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 27382815 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26712968 (View on PubMed)

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 29628563 (View on PubMed)

Soliman AAM, Melika ASM. Epidural bupivacaine and dexmedetomidine versus bupivacaine and opioids for lower vascular surgery. J Med Sci Res. 2018; 1:158-63.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

Farmawy MSE, Mowafy SMS, Wahdan RA. Epidural nalbuphine versus dexmedetomidine as adjuvants to bupivacaine in lower limb orthopedic surgeries for postoperative analgesia: a randomized controlled trial. BMC Anesthesiol. 2023 Dec 6;23(1):401. doi: 10.1186/s12871-023-02348-x.

Reference Type: DERIVED

PMID: 38057695 (View on PubMed)

Other Identifiers

16-8-2021

Identifier Type: -

Identifier Source: org_study_id