Skip to main content
OpenTrials
Completed

NCT Number: NCT04518618

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pruritis Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

21 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Tanta, Algharbia, Egypt

Loading trial locations.

About this study

This prospective randomized double-blind study will be carried out on 80 female patients who will be presented for elective C.S in the Obstetric department in Tanta university hospitals.

Full-term pregnant female aged 21- 30 years presented for elective cesarean section under spinal anesthesia will be included in the study.

The patients will be randomly allocated into two groups by the aid of computer-generated software of randomization. All the local anesthetic mixtures will be prepared under complete aseptic precautions by an anesthesia resident who will not participate in the study and will be blinded to its groups in to: - 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 ugs naloxone.

Once the patient will be admitted to the operating theatre, all monitors will be applied with introduction of 18-gauge peripheral venous cannula and starting fluid preload in the form of lactated ringer solution 7 ml/kg over 30 minutes. While the patient in a sitting position and under complete aseptic precautions, patients will receive spinal block at lumbar 3-4 or 4-5 intervertebral space with an injection of the pre-prepared local anesthetic mixture according to the group of patient. After giving anesthesia and positioning for surgery with a left lateral tilt of 15 degrees, supplemental oxygen at a rate of 4 liters/minute will be applied.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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)

Other names: Intrathecal Fentanyl alone

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

Other names: Intrathecal fentanyl and naloxone

Primary outcomes

  1. The incidence of pruritis

    Time frame: The first 24 hours postoperatively

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

Secondary outcomes

  1. The onset of pruritis

    Time frame: through study completion, average 4 months

    The time interval in minutes from the intrathecal injection to the first incidence of pruritis

  2. The duration of pruritis

    Time frame: through study completion, average 4 months

    the time interval from the first incidence to the last incidence of pruritis

  3. The Severity of pruritis

    Time frame: through study completion, average 4 months

    pruritis VAS score (PVAS is a 10cm long line and a single question, it is most commonly used in clinical trials for measuring itch intensity and features high reliability and concurrent validity. The left end point represents gno itch h and the right end point the gworst imaginable itch). It can be interpreted as follows: VAS 0= No pruritus, VAS < 3 = Mild pruritus, VAS 3-6 = Moderate pruritus, VAS 7-8 = Severe pruritus, VAS . 9=Very severe pruritus.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

The Effect of Adding Ultra-low Dose of Naloxone to Fentanyl on the Incidence of Pruritis After Spinal Anesthesia for Cesarean Section: Prospective Randomized Double-blind Study ÏÑÇÓÉ

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 19, 2020
Registry last updated
Mar 26, 2021

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.