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

NCT ID: NCT04673812

Last Updated: 2021-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-10
• Study Completion Date: 2021-03-10

Brief Summary

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.

Detailed Description

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.

Conditions

Anesthesia, Spinal; Elderly

Study Design

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

Study Groups

Bupivacaine-Fentanyl Spinal Anaesthesia

Group Type: ACTIVE_COMPARATOR

Bupivacaine-fentanyl

Intervention Type: 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.

Bupivacaine-Fentanyl-Naloxone Spinal Anaesthesia

Group Type: ACTIVE_COMPARATOR

Bupivacaine-fentanyl

Intervention Type: 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.

Interventions

Bupivacaine-fentanyl

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.

Intervention Type: DRUG

Other Intervention Names

Naloxone hydrochloride

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: collaborator

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Khaled Abdelfattah Abdallah Sarhan

lecturer of anesthesia,SICU and pain management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Y. Makharita, professor

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

Kasralainy

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MS/19.09.830

Identifier Type: -

Identifier Source: org_study_id