ItchingNCT02951806
Effect of Slow Injection of Fentanyl on the Incidence of Spinal Anesthesia Induced Itching in Cesarean Section
A study testing (R) Rapid spinal fentanyl injection and (S) Slow spinal fentanyl injection in people with Itching, run by Dr. Soliman Fakeeh Hospital.
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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Itching
- What is being tested?
- (R) Rapid spinal fentanyl injection and (S) Slow spinal fentanyl injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Elective and emergency cesarean section parturient.
Who cannot join
- Allergy to any medications, contraindications to spinal anesthesia, those who requested sedation, presence of skin lesions that may cause itching and opioid addiction.
About this study
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.
- Conditions
- Itching
- Being tested
- (R) Rapid spinal fentanyl injection, (S) Slow spinal fentanyl injection
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(R) Rapid spinal fentanyl injectionDrug
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 injectionDrug
Patients will receive 25 micrograms fentanyl ( after dilution with 2.5 ml CSF) in 90 seconds then 10 mg hyperbaric bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| (R) Rapid spinal fentanyl injection | Active comparator | Patients will receive 25 mic fentanyl spinal ( after dilution with 2.5 ml CSF) in 15 seconds then 10 mg hyperbaric bupivacaine. Receives: Drug: (R) Rapid spinal fentanyl injection |
| (S) Slow spinal fentanyl injection | Active comparator | Patients will receive 25 mic fentanyl spinal ( after dilution with 2.5 ml CSF) in 90 seconds then 10 mg hyperbaric bupivacaine. Receives: Drug: (S) Slow spinal fentanyl injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
( 0 - 10) Itching scale
Measured: 60 min
Secondary outcomes (1)
Satisfactory Block ( no pain, Pain relieved by opioids or pain needs general anesthesia
Measured: 60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2019
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ItchingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Soliman Fakeeh Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Amr Aly Ismail Keera, Dr. Soliman Fakeeh Hospital
- Investigators
- Amr A Keera, Principal investigator, Doctor Soliman Fakeeh Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951806
- Sponsor's protocol ID
- 02/IRB/2016
- Status last verified
- Sep 2020
- First submitted
- 19 Oct 2016
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: I hope to publish the data in a respected journal.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Slow Injection of Fentanyl on the Incidence of Spinal Anesthesia Induced Itching in Cesarean Section
- ClinicalTrials.gov ID
- NCT02951806
- Acronym / sponsor ID
- 02/IRB/2016
- Conditions
- Itching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Dr. Soliman Fakeeh HospitalUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (R) Rapid spinal fentanyl injection | Active comparator | Drug: (R) Rapid spinal fentanyl injectionPatients 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 | Active comparator | Drug: (S) Slow spinal fentanyl injectionPatients will receive 25 mic fentanyl spinal ( after dilution with 2.5 ml CSF) in 90 seconds then 10 mg hyperbaric bupivacaine. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Elective and emergency cesarean section parturient.
Key exclusion criteria (1 listed)
- Allergy to any medications, contraindications to spinal anesthesia, those who requested sedation, presence of skin lesions that may cause itching and opioid addiction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (R) Rapid spinal fentanyl injectionPatients will receive 25 micrograms fentanyl ( after dilution with 2.5 ml CSF) in 20 seconds then 10 mg hyperbaric bupivacaine. | Drug | (R) Rapid spinal fentanyl injection |
| (S) Slow spinal fentanyl injectionPatients will receive 25 micrograms fentanyl ( after dilution with 2.5 ml CSF) in 90 seconds then 10 mg hyperbaric bupivacaine. | Drug | (S) Slow spinal fentanyl injection |
Primary outcome
( 0 - 10) Itching scale
Time frame: 60 min
1 secondary outcome
Satisfactory Block ( no pain, Pain relieved by opioids or pain needs general anesthesia
Time frame: 60 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Individual participant dataSharing planned: Yes. I hope to publish the data in a respected journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amr A Keera principal investigator
Doctor Soliman Fakeeh Hospital
Questions about this trial
What is this clinical trial studying?
A study testing (R) Rapid spinal fentanyl injection and (S) Slow spinal fentanyl injection in people with Itching, run by Dr. Soliman Fakeeh Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
( 0 - 10) Itching scale (time frame: 60 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.