Effectiveness of Single Shot Intra-thecal Analgesia in Multiparous Women Scheduled for Normal Vaginal DeliveryNCT05998551
Single Shot Intrathecal Analgesia in Vaginal Delivery
A study testing Dexmedetomidine, Fentanyl and Bupivacaine Hcl 0.5% Inj in people with Effectiveness of Single Shot Intra-thecal Analgesia in Multiparous Women Scheduled for Normal Vaginal Delivery, run by Ain Shams University at 1 site in Egypt.
Trial summary
Effectiveness of single shot intra-thecal analgesia in multiparous women scheduled for normal vaginal delivery Read more about this study
- Who is it for?
- Ages 22 to 45 years, women only
- Conditions the study is for
- Effectiveness of Single Shot Intra-thecal Analgesia in Multiparous Women Scheduled for Normal Vaginal Delivery
- What is being tested?
- Dexmedetomidine, Fentanyl and Bupivacaine Hcl 0.5% Inj
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Oct 2023
- 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 22 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Multiparous women who received antenatal care, presented for vaginal delivery of uncomplicated term pregnancy of singleton fetus with engaged fetal head and cervical dilatation of at least 5 cm requiring oxytocin augmentation, and requested analgesia.
- Age: patients between 22-45 years old.
Who cannot join
- Refusal of procedure or participation in the study.
- Patients with pre-existing or pregnancy-induced hypertension, abnormal fetal heart rate tracings, obesity, endocrinal diseases and/or diagnosed fetal abnormalities.
- Contraindication to neuraxial block.
- Allergy to any of the study drugs.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ainshams University
Cairo
ainshams university
About this study
Official title: Effectiveness of Single Shot Intra-thecal Analgesia in Multiparous Women Scheduled for Normal Vaginal Delivery.
Effectiveness of single shot intra-thecal analgesia in multiparous women scheduled for normal vaginal delivery
Read the detailed description
Labor is a physiological and natural process, as well as a complicated and subjective experience.Except for a few women, childbirth is unquestionably a painful experience. Women's understanding of delivery's pain is influenced by various factors, making each experience special. As opposed to other painful life events, labor pain consistently ranks high on the pain rating scale.
In this study ,the investigators are going to investigate the effectiveness and safety of intrathecal analgesia for labour using bupivacaine with fentanyl or dexmedetomidine.
- Being tested
- Dexmedetomidine, Fentanyl, Bupivacaine Hcl 0.5% Inj
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
intrathecal injection of dexmedetomidine added to hyperbaric bupivacaine
FentanylDrug
intrathecal injection of fentanyl added to hyperbaric bupivacaine
Bupivacaine Hcl 0.5% InjDrug
intrathecal injection of hyperbaric bupivacaine only
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Group | Active comparator | participants will receive intrathecal injection of 5mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml contain 5μg dexmedetomidine(0.05ml dexmedetomidine in insulin syringe+ 0.95ml normal saline). Receives: Drug: Dexmedetomidine |
| Fentanyl group | Active comparator | participants will receive intrathecal injection of 5 mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml contain 12.5μg fentanyl(0.25ml fentanyl in insulin syringe+ 0.75ml normal saline). Receives: Drug: Fentanyl |
| Control group | Active comparator | participants will receive intrathecal injection of 5mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml normal saline Receives: Drug: Bupivacaine Hcl 0.5% Inj |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of pain relief
The duration of pain relief will be defined as the duration from intrathecal injection till the VAS became more than 4
Measured: Up to 6 hours after intrathecal injection
analgesic onset time
The analgesia onset time will be defined as the time from intrathecal injection until the VAS became less than 4
Measured: within 15 minutes after intrathecal injection
maximum level of sensory block
Temperature will be assessed using methylated soaked swabs on both sides of the body
Measured: 15 min after the intrathecal injection
visual analogue scale (VAS) of the labour pain
The VAS (ranging from 0 = pain-free up to 10 = worst imaginable pain) of the labour pain will be recorded before the intrathecal injection, every 5 min for the first 20 min, then every 30 min for 6 hours
Measured: 6 hours after intrathecal injection
S1 regression time
S1 regression time will be defined as the time from intrathecal injection to sensory regression to S1 dermatome
Measured: 6 hours after intrathecal injection
Secondary outcomes (6)
Maternal blood pressure
any change more than 20% of baseline mean arterial pressure
Measured: 6 hours post operative
Maternal heart rate
any change more than 20% of baseline heart rate
Measured: 6 hours post operative
Post operative nausea and vomiting
Number of participants having post operative nausea and vomiting
Measured: 6 hours post operative
Post operative urinary retention
Number of participants having post operative urinary retention
Measured: 6 hours post operative
Fetal heart sounds
Change more than 20% of fetal heart sounds before delivery
Measured: from intrathecal injection till delivery
Fetal APGAR score
APGAR score (1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2 at 1 and 5 minutes after delivery
Measured: till 5 minutes after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Jan 2023
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effectiveness of Single Shot Intra-thecal Analgesia in Multiparous Women Scheduled for Normal Vaginal DeliveryStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The eligible parturients will be randomly allocated into three groups according to the additive added to a fixed dose of local anesthetic (1ml=5mg of 0.5% hyperbaric bupivacaine).Total volume of 2 ml will be given to each patient
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998551
- Sponsor's protocol ID
- intra-thecal analgesia
- Status last verified
- May 2023
- First submitted
- 16 Jun 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Single Shot Intra-thecal Analgesia in Multiparous Women Scheduled for Normal Vaginal Delivery.
- ClinicalTrials.gov ID
- NCT05998551
- Acronym / sponsor ID
- intra-thecal analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 21 Aug 2023 (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.
Effectiveness of single shot intra-thecal analgesia in multiparous women scheduled for normal vaginal delivery
Detailed description
Labor is a physiological and natural process, as well as a complicated and subjective experience.Except for a few women, childbirth is unquestionably a painful experience. Women's understanding of delivery's pain is influenced by various factors, making each experience special. As opposed to other painful life events, labor pain consistently ranks high on the pain rating scale.
In this study ,the investigators are going to investigate the effectiveness and safety of intrathecal analgesia for labour using bupivacaine with fentanyl or dexmedetomidine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The eligible parturients will be randomly allocated into three groups according to the additive added to a fixed dose of local anesthetic (1ml=5mg of 0.5% hyperbaric bupivacaine).Total volume of 2 ml will be given to each patient
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Group | Active comparator | Drug: Dexmedetomidineparticipants will receive intrathecal injection of 5mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml contain 5μg dexmedetomidine(0.05ml dexmedetomidine in insulin syringe+ 0.95ml normal saline). |
| Fentanyl group | Active comparator | Drug: Fentanylparticipants will receive intrathecal injection of 5 mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml contain 12.5μg fentanyl(0.25ml fentanyl in insulin syringe+ 0.75ml normal saline). |
| Control group | Active comparator | Drug: Bupivacaine Hcl 0.5% Injparticipants will receive intrathecal injection of 5mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml normal saline |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
Key exclusion criteria (4 listed)
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 |
|---|---|---|
| Dexmedetomidineintrathecal injection of dexmedetomidine added to hyperbaric bupivacaine | Drug | Dexmedetomidine Group |
| Fentanylintrathecal injection of fentanyl added to hyperbaric bupivacaine | Drug | Fentanyl group |
| Bupivacaine Hcl 0.5% Injintrathecal injection of hyperbaric bupivacaine only | Drug | Control group |
Primary outcome
Duration of pain relief
Time frame: Up to 6 hours after intrathecal injection
The duration of pain relief will be defined as the duration from intrathecal injection till the VAS became more than 4
analgesic onset time
Time frame: within 15 minutes after intrathecal injection
The analgesia onset time will be defined as the time from intrathecal injection until the VAS became less than 4
maximum level of sensory block
Time frame: 15 min after the intrathecal injection
Temperature will be assessed using methylated soaked swabs on both sides of the body
visual analogue scale (VAS) of the labour pain
Time frame: 6 hours after intrathecal injection
The VAS (ranging from 0 = pain-free up to 10 = worst imaginable pain) of the labour pain will be recorded before the intrathecal injection, every 5 min for the first 20 min, then every 30 min for 6 hours
S1 regression time
Time frame: 6 hours after intrathecal injection
S1 regression time will be defined as the time from intrathecal injection to sensory regression to S1 dermatome
6 secondary outcomes
Maternal blood pressure
Time frame: 6 hours post operative
Maternal heart rate
Time frame: 6 hours post operative
Post operative nausea and vomiting
Time frame: 6 hours post operative
Post operative urinary retention
Time frame: 6 hours post operative
Fetal heart sounds
Time frame: from intrathecal injection till delivery
Fetal APGAR score
Time frame: till 5 minutes after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine, Fentanyl and Bupivacaine Hcl 0.5% Inj in people with Effectiveness of Single Shot Intra-thecal Analgesia in Multiparous Women Scheduled for Normal Vaginal Delivery, run by Ain Shams University at 1 site 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Nagdy Rashad (01095825826, mohamed.nagdy@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of pain relief (time frame: Up to 6 hours after intrathecal injection). The study lists 5 primary outcomes in all. 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 21 Aug 2023.