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

NCT04673812 | Completed DMC

• 1 other identifier: MS/19.09.830
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Spinal; Elderly

Keywords

spinal anesthesia; elderly; naloxone; pruritus; post operative cognitive dysfunction

Outcome Measures

Primary Outcomes (1)

• incidence of fentanyl - induced pruritus

  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.

  4 hours postoperative

Secondary Outcomes (3)

• The time for first postoperative analgesic requirements

  24 hours

• Cognitive function using Mini Mental State Examination (MMSE) scoring

  24 hours

• postoperative nausea and vomiting

  24 hours

Study Arms (2)

Bupivacaine-Fentanyl Spinal Anaesthesia

ACTIVE COMPARATOR

Drug: Bupivacaine-fentanyl

Bupivacaine-Fentanyl-Naloxone Spinal Anaesthesia

ACTIVE COMPARATOR

Drug: Bupivacaine-fentanyl

Interventions

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.

Also known as: Naloxone hydrochloride

Bupivacaine-Fentanyl Spinal Anaesthesia; Bupivacaine-Fentanyl-Naloxone Spinal Anaesthesia

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead
• Mansoura University: collaborator

Study Sites (1)

Kasralainy

Cairo, Egypt

Location

MeSH Terms

Conditions

Pruritus

Interventions

Naloxone

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Mohamed Y. Makharita, professor

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia,SICU and pain management

Study Record Dates

• First Submitted: December 13, 2020
• First Posted: December 17, 2020
• Study Start: December 10, 2020
• Primary Completion: March 10, 2021
• Study Completion: March 10, 2021
• Last Updated: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)