Effect of Intrathecal Naloxone in the Incidence of Pruritis After C.S

NCT04518618 | Completed

• 1 other identifier: 33954/7/20
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

Brief Summary

This randomized prospective double-blind trial will be conducted on 80 Full-term pregnant females aged 21- 30 years presented for elective cesarean section under spinal anesthesia where they will be randomly allocated into two equal groups:-

• Group F (40 Patients): Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ug of fentanyl (0.5 ml).
• Group FN (40 patients): Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ug of fentanyl (0.5 ml) plus 20 ug naloxone. The study aim is to evaluate the effect of adding an ultra-low dose of naloxone (20 ug) to hyperbaric bupivacaine (10 mg0 and fentanyl (25 ug) in spinal anesthesia for C.S. Primary outcome: The incidence of pruritis Secondary outcome: The onset, the duration, the site, and the severity of pruritis.

Conditions

Pruritis

Keywords

Pruritis; Naloxone; Spinal anesthesia; Fentanyl; Cesarean section

Outcome Measures

Primary Outcomes (1)

• The incidence of pruritis

  The percent of patients who will complain from pruritis in the first 24 hours after surgery

  The first 24 hours postoperatively

Secondary Outcomes (3)

• The onset of pruritis

  through study completion, average 4 months

• The duration of pruritis

  through study completion, average 4 months

• The Severity of pruritis

  through study completion, average 4 months

Study Arms (2)

Group F

EXPERIMENTAL

Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ugs of fentanyl (0.5 ml).

Drug: Fentanyl

Group FN

EXPERIMENTAL

Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ugs of fentanyl (0.5 ml) plus 20 ugs naloxone.

Drug: Fentanyl; Drug: Naloxone

Interventions

Fentanyl DRUG

Spinal anesthesia will be performed with injection of 2.5 ml which will be composed of 10 mg hyperbaric bupivacaine (2 ml) and 25 ugs fentanyl (0.5 ml)

Also known as: Intrathecal Fentanyl alone

Group F; Group FN

Naloxone DRUG

Spinal anesthesia will be performed with injection of 2.5 ml which will be composed of 10 mg hyperbaric bupivacaine (2 ml) and fentanyl 25 ug combined with 20 ugs naloxone in 0.5 ml

Also known as: Intrathecal fentanyl and naloxone

Group FN

Eligibility Criteria

• Age: 21 Years - 30 Years
• Gender Eligibility Details: Full-term pregnant females undergoing elective C.S
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Full-term pregnant female aged 21- 30 years presented for elective cesarean section under spinal anesthesia.

You may not qualify if:

• Patients with pregnancy less than 36 weeks or more than 40 weeks
• Patients with hypertension, pre-eclampsia, or eclampsia.
• Patients with diabetes
• Patients with cardiovascular disease and /or arrhythmia.
• Patients with placenta previa, accreta, percreta.
• Obese patients with BMI \>36 Kg/m2
• Patients with height less than 160 Cm
• Multigravida
• Polyhydramnious patients

Sponsors & Collaborators

• Tanta University: lead

Study Sites (2)

Faculty of Medicine

Tanta, Algharbia, 31511, Egypt

Location

Tanta University hospitals

Tanta, 31511, Egypt

Location

MeSH Terms

Conditions

Pruritus

Interventions

Fentanyl; Naloxone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Sameh Abdelkhalik, M.D

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: * The patients will be blinded to their groups. * An anesthesia resident who will not participate in the study and have no subsequent rule in it will help in the preparation of local anesthetic mixtures under strict aseptic precautions. * The anesthetist who will perform the spinal anesthesia will be blinded to the local anesthetic mixtures he will inject intrathecally. * An assistant nurse who will be blinded to the study groups and will have no subsequent rule in it will help in collection of the data of measurments.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 19, 2020
• Study Start: September 11, 2020
• Primary Completion: March 7, 2021
• Study Completion: March 7, 2021
• Last Updated: March 26, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: 6 months after approval of the publication of the trial.
• Access Criteria: Contact the principle investigator

Locations

EG (2)