PruritisNCT04518618
Effect of Intrathecal Naloxone in the Incidence of Pruritis After C.S
A study testing Fentanyl and Naloxone in people with Pruritis, run by Tanta University at 2 sites in Egypt.
Trial summary
This randomized prospective double-blind trial will be conducted on 80 Full-term pregnant females aged 21- 30 years presented for elective cesarean section under spinal anesthesia where they will be randomly allocated into two equal groups:- Group F (40 Patients): Patients in this group will receive spinal anesthesia… Read more about this study
- Who is it for?
- Ages 21 to 30 years, women only
- Conditions the study is for
- Pruritis
- What is being tested?
- Fentanyl and Naloxone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 2 sitesEgypt
- Study dates
- 11 Sep 2020to 7 Mar 2021
- 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 21 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Full-term pregnant female aged 21- 30 years presented for elective cesarean section under spinal anesthesia.
Who cannot join
- Patients with pregnancy less than 36 weeks or more than 40 weeks
- Patients with hypertension, pre-eclampsia, or eclampsia.
- Patients with diabetes
- Patients with cardiovascular disease and /or arrhythmia.
- Patients with placenta previa, accreta, percreta.
- Obese patients with BMI >36 Kg/m2
Show all 9Show fewer
- Patients with height less than 160 Cm
- Multigravida
- Polyhydramnious patients
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Medicine
Tanta, Algharbia, 31511
Tanta University hospitals
Tanta, 31511
About this study
Official title: The Effect of Adding Ultra-low Dose of Naloxone to Fentanyl on the Incidence of Pruritis After Spinal Anesthesia for Cesarean Section: Prospective Randomized Double-blind Study ÏÑÇÓÉ
This randomized prospective double-blind trial will be conducted on 80 Full-term pregnant females aged 21- 30 years presented for elective cesarean section under spinal anesthesia where they will be randomly allocated into two equal groups:-
- Group F (40 Patients): Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ug of fentanyl (0.5 ml).
- Group FN (40 patients): Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ug of fentanyl (0.5 ml) plus 20 ug naloxone.
Read more
The study aim is to evaluate the effect of adding an ultra-low dose of naloxone (20 ug) to hyperbaric bupivacaine (10 mg0 and fentanyl (25 ug) in spinal anesthesia for C.S.
Primary outcome: The incidence of pruritis Secondary outcome: The onset, the duration, the site, and the severity of pruritis.
Read the detailed description
This prospective randomized double-blind study will be carried out on 80 female patients who will be presented for elective C.S in the Obstetric department in Tanta university hospitals.
Full-term pregnant female aged 21- 30 years presented for elective cesarean section under spinal anesthesia will be included in the study.
The patients will be randomly allocated into two groups by the aid of computer-generated software of randomization. All the local anesthetic mixtures will be prepared under complete aseptic precautions by an anesthesia resident who will not participate in the study and will be blinded to its groups in to: - Group F (40 Patients): Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ug of fentanyl (0.5 ml).
Group FN (40 patients): Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ug of fentanyl (0.5 ml) plus 20 ugs naloxone.
Once the patient will be admitted to the operating theatre, all monitors will be applied with introduction of 18-gauge peripheral venous cannula and starting fluid preload in the form of lactated ringer solution 7 ml/kg over 30 minutes. While the patient in a sitting position and under complete aseptic precautions, patients will receive spinal block at lumbar 3-4 or 4-5 intervertebral space with an injection of the pre-prepared local anesthetic mixture according to the group of patient. After giving anesthesia and positioning for surgery with a left lateral tilt of 15 degrees, supplemental oxygen at a rate of 4 liters/minute will be applied.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called Intrathecal Fentanyl alone
Spinal anesthesia will be performed with injection of 2.5 ml which will be composed of 10 mg hyperbaric bupivacaine (2 ml) and 25 ugs fentanyl (0.5 ml)
NaloxoneDrug
Also called Intrathecal fentanyl and naloxone
Spinal anesthesia will be performed with injection of 2.5 ml which will be composed of 10 mg hyperbaric bupivacaine (2 ml) and fentanyl 25 ug combined with 20 ugs naloxone in 0.5 ml
| Study group | Role | What they receive |
|---|---|---|
| Group F | Experimental | Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ugs of fentanyl (0.5 ml). Receives: Drug: Fentanyl |
| Group FN | Experimental | Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ugs of fentanyl (0.5 ml) plus 20 ugs naloxone. Receives: Drug: Fentanyl; Drug: Naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of pruritis
The percent of patients who will complain from pruritis in the first 24 hours after surgery
Measured: The first 24 hours postoperatively
Secondary outcomes (3)
The onset of pruritis
The time interval in minutes from the intrathecal injection to the first incidence of pruritis
Measured: through study completion, average 4 months
The duration of pruritis
the time interval from the first incidence to the last incidence of pruritis
Measured: through study completion, average 4 months
The Severity of pruritis
pruritis VAS score (PVAS is a 10cm long line and a single question, it is most commonly used in clinical trials for measuring itch intensity and features high reliability and concurrent validity. The left end point represents gno itch h and the right end point the gworst imaginable itch). It can be interpreted as follows: VAS 0= No pruritus, VAS < 3 = Mild pruritus, VAS 3-6 = Moderate pruritus, VAS 7-8 = Severe pruritus, VAS . 9=Very severe pruritus.
Measured: through study completion, average 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start11 Sep 2020
- Primary completion7 Mar 2021
- Study completion7 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritisStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Abdelkhalik Ahmed Ismaiel, Tanta University
- Investigators
- Sameh Abdelkhalik, M.D, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518618
- Sponsor's protocol ID
- 33954/7/20
- Status last verified
- Mar 2021
- First submitted
- 11 Aug 2020
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data of primary outcome will be available with the corresponding author till 6 months after approval of the publication of the trial.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adding Ultra-low Dose of Naloxone to Fentanyl on the Incidence of Pruritis After Spinal Anesthesia for Cesarean Section: Prospective Randomized Double-blind Study ÏÑÇÓÉ
- ClinicalTrials.gov ID
- NCT04518618
- Acronym / sponsor ID
- 33954/7/20
- Conditions
- Pruritis
- Keywords
- Pruritis, Naloxone, Spinal anesthesia, Fentanyl, Cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 7 Mar 2021 (actual)
- Study completion
- 7 Mar 2021 (actual)
- First posted
- 19 Aug 2020 (actual)
- 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.
This randomized prospective double-blind trial will be conducted on 80 Full-term pregnant females aged 21- 30 years presented for elective cesarean section under spinal anesthesia where they will be randomly allocated into two equal groups:-
- Group F (40 Patients): Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ug of fentanyl (0.5 ml).
- Group FN (40 patients): Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ug of fentanyl (0.5 ml) plus 20 ug naloxone.
The study aim is to evaluate the effect of adding an ultra-low dose of naloxone (20 ug) to hyperbaric bupivacaine (10 mg0 and fentanyl (25 ug) in spinal anesthesia for C.S.
Primary outcome: The incidence of pruritis Secondary outcome: The onset, the duration, the site, and the severity of pruritis.
Detailed description
This prospective randomized double-blind study will be carried out on 80 female patients who will be presented for elective C.S in the Obstetric department in Tanta university hospitals.
Full-term pregnant female aged 21- 30 years presented for elective cesarean section under spinal anesthesia will be included in the study.
The patients will be randomly allocated into two groups by the aid of computer-generated software of randomization. All the local anesthetic mixtures will be prepared under complete aseptic precautions by an anesthesia resident who will not participate in the study and will be blinded to its groups in to: - Group F (40 Patients): Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ug of fentanyl (0.5 ml).
Group FN (40 patients): Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ug of fentanyl (0.5 ml) plus 20 ugs naloxone.
Once the patient will be admitted to the operating theatre, all monitors will be applied with introduction of 18-gauge peripheral venous cannula and starting fluid preload in the form of lactated ringer solution 7 ml/kg over 30 minutes. While the patient in a sitting position and under complete aseptic precautions, patients will receive spinal block at lumbar 3-4 or 4-5 intervertebral space with an injection of the pre-prepared local anesthetic mixture according to the group of patient. After giving anesthesia and positioning for surgery with a left lateral tilt of 15 degrees, supplemental oxygen at a rate of 4 liters/minute will be applied.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group F | Experimental | Drug: FentanylPatients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ugs of fentanyl (0.5 ml). |
| Group FN | Experimental | Drug: Fentanyl, Drug: NaloxonePatients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ugs of fentanyl (0.5 ml) plus 20 ugs naloxone. |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Full-term pregnant female aged 21- 30 years presented for elective cesarean section under spinal anesthesia.
Key exclusion criteria (9 listed)
- Patients with pregnancy less than 36 weeks or more than 40 weeks
- Patients with hypertension, pre-eclampsia, or eclampsia.
- Patients with diabetes
- Patients with cardiovascular disease and /or arrhythmia.
- Patients with placenta previa, accreta, percreta.
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 |
|---|---|---|
| FentanylAlso: Intrathecal Fentanyl aloneSpinal anesthesia will be performed with injection of 2.5 ml which will be composed of 10 mg hyperbaric bupivacaine (2 ml) and 25 ugs fentanyl (0.5 ml) | Drug | Group F, Group FN |
| NaloxoneAlso: Intrathecal fentanyl and naloxoneSpinal anesthesia will be performed with injection of 2.5 ml which will be composed of 10 mg hyperbaric bupivacaine (2 ml) and fentanyl 25 ug combined with 20 ugs naloxone in 0.5 ml | Drug | Group FN |
Primary outcome
The incidence of pruritis
Time frame: The first 24 hours postoperatively
The percent of patients who will complain from pruritis in the first 24 hours after surgery
3 secondary outcomes
The onset of pruritis
Time frame: through study completion, average 4 months
The duration of pruritis
Time frame: through study completion, average 4 months
The Severity of pruritis
Time frame: through study completion, average 4 months
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 26 Mar 2021.
- Individual participant dataSharing planned: Yes. The data of primary outcome will be available with the corresponding author till 6 months after approval of the publication of the trial.
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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.
Sameh Abdelkhalik, M.D principal investigator
Tanta University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl and Naloxone in people with Pruritis, run by Tanta University at 2 sites in Egypt.
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 9 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 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The incidence of pruritis (time frame: The first 24 hours postoperatively). 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 26 Mar 2021.