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

Dr. Soliman Fakeeh Hospital

Status: Completed

Conditions: Itching

Treatments: Drug: (R) Rapid spinal fentanyl injection; Drug: (S) Slow spinal fentanyl injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02951806

02/IRB/2016

Details and patient eligibility

About

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.

Enrollment: 215 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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215 participants in 2 patient groups

(R) Rapid spinal fentanyl injection

Active Comparator group

Description:

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

Treatment:

Drug: (R) Rapid spinal fentanyl injection

(S) Slow spinal fentanyl injection

Active Comparator group

Description:

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

Treatment:

Drug: (S) Slow spinal fentanyl injection