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

NCT ID: NCT04518618

Last Updated: 2021-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-11
• Study Completion Date: 2021-03-07

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.

Conditions

Pruritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Group F

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

Group Type: EXPERIMENTAL

Fentanyl

Intervention Type: 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)

Group FN

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.

Group Type: EXPERIMENTAL

Fentanyl

Intervention Type: 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)

Naloxone

Intervention Type: 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

Interventions

Fentanyl

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

Naloxone

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

Intervention Type: DRUG

Other Intervention Names

Intrathecal Fentanyl alone; Intrathecal fentanyl and naloxone

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Sameh Abdelkhalik Ahmed Ismaiel

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sameh Abdelkhalik, M.D

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

Faculty of Medicine

Tanta, Algharbia, Egypt

Tanta University hospitals

Tanta, , Egypt

Countries

Egypt

Other Identifiers

33954/7/20

Identifier Type: -

Identifier Source: org_study_id