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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02951806
Enrollment
215
Registered
2016-11-01
Start date
2016-09-30
Completion date
2020-06-30
Last updated
2020-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Itching

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.

Interventions

DRUG(R) Rapid spinal fentanyl injection

Patients will receive 25 micrograms fentanyl ( after dilution with 2.5 ml CSF) in 20 seconds then 10 mg hyperbaric bupivacaine.

DRUG(S) Slow spinal fentanyl injection

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

Sponsors

Dr. Soliman Fakeeh Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
( 0 - 10) Itching scale60 min

Secondary

MeasureTime frame
Satisfactory Block ( no pain, Pain relieved by opioids or pain needs general anesthesia60 min

Other

MeasureTime frame
Hypotension ( yes or no)60 minutes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026