Effect of Intrathecal Naloxone in the Incidence of Pruritis After C.S
Condition: Pruritis
MeSH terms: Pruritus
Study type: Interventional

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.
    

Intervention name(s): Fentanyl; Naloxone
Intervention type(s): Drug; Drug
Intervention description(s): 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); 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 intervention name(s): Intrathecal Fentanyl alone; Intrathecal fentanyl and naloxone
Intervention MeSH terms: Fentanyl; Naloxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Pruritis; Naloxone; Spinal anesthesia; Fentanyl; Cesarean section