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Clinical Trials/NCT02951806
NCT02951806
Completed
Not Applicable

Effect of Slow Injection of Fentanyl on the Incidence of Spinal Anesthesia Induced Itching in Cesarean Section

Dr. Soliman Fakeeh Hospital0 sites215 target enrollmentSeptember 2016

Overview

Phase
Not Applicable
Intervention
(R) Rapid spinal fentanyl injection
Conditions
Itching
Sponsor
Dr. Soliman Fakeeh Hospital
Enrollment
215
Primary Endpoint
( 0 - 10) Itching scale
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Pruritus is a troublesome side-effect of neuraxial (epidural and intrathecal) opioids. Sometimes it may be more unpleasant than pain itself. The incidence of pruritus is 83% in postpartum patients and 69% in non-pregnant patients including males and females (1). Some researchers concluded that slow injection rate of hyperbaric bupivacaine may be a simple and effective way to reduce the incidence and severity of hypotension during cesarean section under spinal anesthesia (2). In this new research I want to investigate the effect of slow injection of fentanyl separately, in spinal anesthesia for cesarean section, on the incidence of itching In this double blind randomized study two hundred parturient will be randomly allocated in to two groups; Group (R) will receive 25 mic fentanyl spinal ( after dilution with 2.5 ml CSF) in 15 seconds. Group (S) will receive the same dose in 90 seconds All parturient will receive 10 mg bupivacaine in 45 min after fentanyl. Exclusion criteria will be those with allergy to any medications, contraindications to spinal anesthesia, those who requested sedation, presence of skin lesions that may cause itching and opioid addiction.

Parturient will be monitored regarding the incidence of itching, hypotension, nausea and vomiting. Onset and level of sensory block will also be recorded.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
June 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Dr. Soliman Fakeeh Hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr. Amr Aly Ismail Keera

Prof. Amr Aly Keera

Dr. Soliman Fakeeh Hospital

Eligibility Criteria

Inclusion Criteria

  • Elective and emergency cesarean section parturient.

Exclusion Criteria

  • Allergy to any medications, contraindications to spinal anesthesia, those who requested sedation, presence of skin lesions that may cause itching and opioid addiction.

Arms & Interventions

(R) Rapid spinal fentanyl injection

Patients will receive 25 mic fentanyl spinal ( after dilution with 2.5 ml CSF) in 15 seconds then 10 mg hyperbaric bupivacaine.

Intervention: (R) Rapid spinal fentanyl injection

(S) Slow spinal fentanyl injection

Patients will receive 25 mic fentanyl spinal ( after dilution with 2.5 ml CSF) in 90 seconds then 10 mg hyperbaric bupivacaine.

Intervention: (S) Slow spinal fentanyl injection

Outcomes

Primary Outcomes

( 0 - 10) Itching scale

Time Frame: 60 min

Secondary Outcomes

  • Satisfactory Block ( no pain, Pain relieved by opioids or pain needs general anesthesia(60 min)

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