Effect of Slow Injection of Fentanyl on the Incidence of Spinal Anesthesia Induced Itching in Cesarean Section
Primary Purpose
Itching
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
(R) Rapid spinal fentanyl injection
(S) Slow spinal fentanyl injection
Sponsored by
About this trial
This is an interventional prevention trial for Itching
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
(R) Rapid spinal fentanyl injection
(S) Slow spinal fentanyl injection
Arm Description
Patients will receive 25 mic fentanyl spinal ( after dilution with 2.5 ml CSF) in 15 seconds then 10 mg hyperbaric bupivacaine.
Patients will receive 25 mic fentanyl spinal ( after dilution with 2.5 ml CSF) in 90 seconds then 10 mg hyperbaric bupivacaine.
Outcomes
Primary Outcome Measures
( 0 - 10) Itching scale
Secondary Outcome Measures
Satisfactory Block ( no pain, Pain relieved by opioids or pain needs general anesthesia
Full Information
NCT ID
NCT02951806
First Posted
October 19, 2016
Last Updated
September 5, 2020
Sponsor
Dr. Soliman Fakeeh Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02951806
Brief Title
Effect of Slow Injection of Fentanyl on the Incidence of Spinal Anesthesia Induced Itching in Cesarean Section
Official Title
Effect of Slow Injection of Fentanyl on the Incidence of Spinal Anesthesia Induced Itching in Cesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
June 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Soliman Fakeeh Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Itching
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
215 (Actual)
8. Arms, Groups, and Interventions
Arm Title
(R) Rapid spinal fentanyl injection
Arm Type
Active Comparator
Arm Description
Patients will receive 25 mic fentanyl spinal ( after dilution with 2.5 ml CSF) in 15 seconds then 10 mg hyperbaric bupivacaine.
Arm Title
(S) Slow spinal fentanyl injection
Arm Type
Active Comparator
Arm Description
Patients will receive 25 mic fentanyl spinal ( after dilution with 2.5 ml CSF) in 90 seconds then 10 mg hyperbaric bupivacaine.
Intervention Type
Drug
Intervention Name(s)
(R) Rapid spinal fentanyl injection
Intervention Description
Patients will receive 25 micrograms fentanyl ( after dilution with 2.5 ml CSF) in 20 seconds then 10 mg hyperbaric bupivacaine.
Intervention Type
Drug
Intervention Name(s)
(S) Slow spinal fentanyl injection
Intervention Description
Patients will receive 25 micrograms fentanyl ( after dilution with 2.5 ml CSF) in 90 seconds then 10 mg hyperbaric bupivacaine.
Primary Outcome Measure Information:
Title
( 0 - 10) Itching scale
Time Frame
60 min
Secondary Outcome Measure Information:
Title
Satisfactory Block ( no pain, Pain relieved by opioids or pain needs general anesthesia
Time Frame
60 min
Other Pre-specified Outcome Measures:
Title
Hypotension ( yes or no)
Time Frame
60 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr A Keera
Organizational Affiliation
Doctor Soliman Fakeeh Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
I hope to publish the data in a respected journal.
Learn more about this trial
Effect of Slow Injection of Fentanyl on the Incidence of Spinal Anesthesia Induced Itching in Cesarean Section
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