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

Primary Purpose

Pruritis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Fentanyl
Naloxone
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pruritis focused on measuring Pruritis, Naloxone, Spinal anesthesia, Fentanyl, Cesarean section

Eligibility Criteria

21 Years - 30 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine
  • Tanta University hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group F

Group FN

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The onset of pruritis
The time interval in minutes from the intrathecal injection to the first incidence of pruritis
The duration of pruritis
the time interval from the first incidence to the last incidence of pruritis
The Severity of pruritis
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.

Full Information

First Posted
August 11, 2020
Last Updated
March 24, 2021
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT04518618
Brief Title
Effect of Intrathecal Naloxone in the Incidence of Pruritis After C.S
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 11, 2020 (Actual)
Primary Completion Date
March 7, 2021 (Actual)
Study Completion Date
March 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritis
Keywords
Pruritis, Naloxone, Spinal anesthesia, Fentanyl, Cesarean section

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group F
Arm Type
Experimental
Arm Description
Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ugs of fentanyl (0.5 ml).
Arm Title
Group FN
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Intrathecal Fentanyl alone
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Naloxone
Other Intervention Name(s)
Intrathecal fentanyl and naloxone
Intervention Description
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
Primary Outcome Measure Information:
Title
The incidence of pruritis
Description
The percent of patients who will complain from pruritis in the first 24 hours after surgery
Time Frame
The first 24 hours postoperatively
Secondary Outcome Measure Information:
Title
The onset of pruritis
Description
The time interval in minutes from the intrathecal injection to the first incidence of pruritis
Time Frame
through study completion, average 4 months
Title
The duration of pruritis
Description
the time interval from the first incidence to the last incidence of pruritis
Time Frame
through study completion, average 4 months
Title
The Severity of pruritis
Description
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.
Time Frame
through study completion, average 4 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Full-term pregnant females undergoing elective C.S
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh Abdelkhalik, M.D
Organizational Affiliation
Faculty of Medicine, Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Tanta
State/Province
Algharbia
ZIP/Postal Code
31511
Country
Egypt
Facility Name
Tanta University hospitals
City
Tanta
ZIP/Postal Code
31511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data of primary outcome will be available with the corresponding author till 6 months after approval of the publication of the trial.
IPD Sharing Time Frame
6 months after approval of the publication of the trial.
IPD Sharing Access Criteria
Contact the principle investigator

Learn more about this trial

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

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