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NCT Number: NCT04673812

Influence Of Low Dose Intrathecal Naloxone On Bupivacaine - Fentanyl Spinal Anaesthesia For Lower Limb Orthopedic Surgery In Elderly Patients

Fentanyl is a safer alternative than morphine in the management of postoperative pain in elderly. However, pruritus, nausea and vomiting are unwanted side effects of intrathecal fentanyl administration, that can decrease patient satisfaction with anaesthesia, delay post anaesthesia care unit ( PACU ) discharge, and increase costs.

The incidence of pruritus with neuraxial fentanyl is high. The incidence of pruritus in non-obstetric surgery patients after intrathecal fentanyl ranges from 53% to 79%.

Naloxone hydrochloride is a pure opioid competitive antagonist. Small doses of naloxone may reduce Fentanyl-associated adverse effects, such as pruritus, nausea and vomiting without affecting analgesia.

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Key information

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasralainy

Cairo, Egypt

About this study

The aim of this study is to evaluate the effect of adding low dose intathecal naloxone to bupivacaine - fentanyl spinal anesthesia in elderly patients scheduled for unilateral lower limb orthopedic surgeries on opioid induced side effects namely pruritus, postoperative analgesia and the incidence of postoperative cognitive dysfunction (POCD) in elderly.

A four category verbal rating scale VRS-4 ( 0 to 3 scale ) will be used for assessment of intrathecal fentanyl induced side effects including pruritus, nausea, vomiting and shivering.

Mini Mental State Examination ( MMSE ) test will be applied to all patients pre- and post- operative to assess the incidence and the degree of POCD.

An 11 points Verbal Numerical Rating Scale VNRS for pain assessment will be also applied to all patients postoperatively to assess the effect on postoperative analgesia.

  • Cannulation: Peripheral cannulae ( size 20 gauge or 18 gauge ) will be inserted to all patients . Ringer's acetate warmed up to 37°C will be infused slowly at rate of 7ml/kg, 30 min before induction of spinal anaesthesia. A single intravenous ( I.V. ) dose of prophylactic antibiotic after a negative sensitivity test will be given to all patients 15-30 min. before operation.
  • Induction: Patient will receive spinal anaesthesia with 12.5 mg hyperbaric Bupivacaine 0.5% ( 2.5 mL ) plus 25 µg Fentanyl ( 0.5 mL ) and 20 µg Naloxone ( prepared in 0.5 mL normal saline ) added in the same syringe in a total volume of 3.5 mL..
  • Spinal anaesthesia will be conducted while the patients are in the sitting position and under complete aseptic conditions; a lumber puncture at L3-4 or L4-5 interspaces will be performed with a 25- gauge Quincke spinal needle after infiltrating the skin with 2 ml of lidocaine 2%. After a successful dural puncture and ensuring free flow of cerebrospinal fluid, injectates will be injected slowly over 20 seconds without barbotage or aspiration according to group of the patient. Immediately, patients will be turned into the supine position. Oxygen 2-3 L/min will be applied to all patients via nasal prongs.

Evolution and regression of sensory and motor block will be evaluated. Sensation will be assessed by pinprick in the mid-clavicular line as follows; Grade 0: Sharp pain felt, Grade I: Analgesia, dull sensation felt, Grade II: Anesthesia, no sensation felt. Motor blockade will be assessed according to Modified Bromage Scale.

Hemodynamics ( mean arterial blood pressure MAP, heart rate HR and oxygen saturation SpO2 ) will be also recorded at predetermined accurate times.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 60y of either gender.
  • ASA physical status III or below.
  • Patients scheduled for elective unilateral lower limb orthopedic surgery.

Exclusion criteria

  • Morbid obese patients.
  • Severe or uncompensated cardiovascular, renal, hepatic or endocrinal diseases.
  • Allergy to one of the agents used.
  • Severely altered consciousness level.
  • Coagulopathy
  • Increased intracranial pressure
  • Neuromuscular diseases
  • Severe spinal deformity
  • Patients on opioid analgesics or opioid abuse
  • Multi traumatized patients
  • Patients with preoperative Mini Mental State Examination ( MMSE ) scoring < 24

Treatment and study plan

Bupivacaine-fentanyl

Drug

Bupivacaine-Fentanyl (BF) group (46 patients): will receive spinal anaesthesia with 12.5 mg hyperbaric Bupivacaine 0.5% (2.5 mL) plus 25 µg Fentanyl (0.5 mL) and (0.5 mL) normal saline added in the same syringe in a total volume of 3.5 mL.

Bupivacaine-Fentanyl-Naloxone (BFN) group (46 patients): will receive spinal anaesthesia with 12.5 mg hyperbaric Bupivacaine 0.5% (2.5 mL) plus 25 µg Fentanyl (0.5 mL) and 20 µg Naloxone (prepared in 0.5 mL normal saline) added in the same syringe in a total volume of 3.5 mL.

Other names: Naloxone hydrochloride

Primary outcomes

  1. incidence of fentanyl - induced pruritus

    Time frame: 4 hours postoperative

    A four category verbal rating scale VRS-4 ( 0 to 3 scale ) which will be will be explained to all patients, where ( 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms ) with the basal preoperative value is being recorded.

Secondary outcomes

  1. The time for first postoperative analgesic requirements

    Time frame: 24 hours

  2. Cognitive function using Mini Mental State Examination (MMSE) scoring

    Time frame: 24 hours

  3. postoperative nausea and vomiting

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Collaborators

  • Mansoura University

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 17, 2020
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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