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

Not Applicable

Completed

• Conditions: Itching
• Interventions: Drug: (R) Rapid spinal fentanyl injection; Drug: (S) Slow spinal fentanyl injection

• Registration Number: NCT02951806
• Lead Sponsor: Dr. Soliman Fakeeh Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-10-19
• Study First Submitted QC: 2016-10-29
• Study First Posted: 2016-11-01
• Primary Completion: 2019-03
• Study Completion: 2020-06
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-05
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 215

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
(R) Rapid spinal fentanyl injection	(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.
(S) Slow 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.

Primary Outcome Measures

Name	Time	Method
( 0 - 10) Itching scale	60 min

Secondary Outcome Measures

Name	Time	Method
Satisfactory Block ( no pain, Pain relieved by opioids or pain needs general anesthesia	60 min