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

Itching Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02951806
• Other study ID #: 02/IRB/2016
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: June 2020

Study information

• Verified date: September 2020
• Source: Dr. Soliman Fakeeh Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: June 2020
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Itching
• Pruritus

Intervention

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.
• (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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Soliman Fakeeh Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hypotension ( yes or no)		60 minutes
Primary	( 0 - 10) Itching scale		60 min
Secondary	Satisfactory Block ( no pain, Pain relieved by opioids or pain needs general anesthesia		60 min