Vaginal DeliveryPhase 4SSSANCT06823349
Comparative Analysis of Analgesic Efficacy: by Single Shot Intrathecal Analgesia (SSSA) in Normal Labor
A Phase 4 study testing Dexmedetomidine, fentanyl and Saline 0.9% in people with Vaginal Delivery and Normal Labor, run by Jehan George Sadek at 1 site in Egypt.
Trial summary
the goal of this randomized control trial is to compare the effect of adding fentanyl v.s dexmedetomidine to bupivacaine in single shot spinal analgesia in achievement of analgesia by decreasing visual analogue scale, onset and increasing duration of analgesia in normal labor. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Delivery, Normal Labor
- What is being tested?
- Dexmedetomidine, fentanyl and Saline 0.9%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 31 Jul 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ASA I-II.
- Uncomplicated pregnancy.
- At term \& singleton fetus.
- Cervical dilatation > 5cm
- Cephalic presentations
Who cannot join
- Patient refusal.
- Bleeding disorders and patients on anticoagulant drugs.
- Infection at site of injection.
- Spine deformity.
- Allergy to any of study medications.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Analysis of Analgesic Efficacy and Maternal Satisfaction: Single Shot Intrathecal Bupivacaine With Fentanyl Versus Bupivacaine With Dexmedetomidine in Normal Labor, Randomized Control Clinical Trial
the goal of this randomized control trial is to compare the effect of adding fentanyl v.s dexmedetomidine to bupivacaine in single shot spinal analgesia in achievement of analgesia by decreasing visual analogue scale, onset and increasing duration of analgesia in normal labor.
Read the detailed description
on arrival to the operating room, the demographic and baseline data will be collected, which include sections about age, height, weight, primigravida or multigravida, cervical dilation at the time of performing labor analgesia, fetus presentation, presence of rupture of membrane, baseline pain scores will be assessed using a 10-cm VAS (0 = no pain and 10 = worst imaginable pain) before SSSA. Intravenous access will be achieved in all patients loading will be undertaken using 500 ml Ringer's solution, baseline values of pulse rate (PR), respiratory rate (RR), hemoglobin oxygen saturation (SpO2), and arterial blood pressure (ABP) will be recorded. SSSA will be performed with the parturient in the sitting position under complete aseptic precautions at the L3-L4 level using a 25-gauge spinal needles. The correct positioning of the needle tip in the intrathecal space will be confirmed by the observation of a free flow of cerebrospinal fluid, and then the prefilled study drug will be injected intrathecally which is 2.5 mg bupivacaine plus 25 mic fentanyl or 5 mic dexmedetomidine or 0.5 ml saline according to different groups.
parturient will then turn to the supine position, and a wedge will be placed under the right buttocks to prevent aortocaval compression. VAS will be evaluated every 5 min for the first 30 min, followed by every 20 min for 3 hours then every 30 min for next 3 hours. If VAS 8 or more the instigators will give the patient 50 mg intramuscular pethidine.
Maternal blood pressure, heart rate, respiratory rate, and oxygen saturation will be measured and recorded noninvasively every 5 min for the first half hour, followed by every 20 min for 3 hours, then every 1 h for next 3 hours. the investigators will give 5 mg ephedrine if there is hypotension ( decrease in ABP more than 25% of the baseline ABP) and .5 mg atropine if there is bradycardia (HR less than 50 beats per minute). Side effects such as hypotension, nausea, vomiting, bradycardia, shivering, pruritus, and tachycardia will be recorded. The first- and fifth-minute Apgar scores will also be recorded. The onset, duration of analgesia, and obstetric and neonatal outcomes will be compared.
- Conditions
- Vaginal Delivery, Normal Labor
- Being tested
- Dexmedetomidine, fentanyl, Saline 0.9%
- Keywords
- painless normal labor, Single shot spinal analgesia in vaginal delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
5 mic dexmedetomidine will be given intrathecally added to 2.5 mg bupivacaine
fentanylDrug
25 mic of fentanyl will be given intrathecally added to 2.5 mg bupivacaine
Saline 0.9%Drug
0.5 ml of saline 0.9% will be given intrathecally added to 2.5 mg of bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | the investigators give 5 mic of dexmedetomidine (0.5 ml) added to 2.5 mg bupivacaine (0.5 ml) as total volume 1 ml intrathecally Receives: Drug: Dexmedetomidine |
| fentanyl | Active comparator | the investigators give 25 mic of fentanyl (0.5 ml) added to 2.5 mg bupivacaine (0.5 ml) as total volume 1 ml intrathecally Receives: Drug: fentanyl |
| Bupivacaine only | Placebo comparator | the investigators give 0.5 ml saline 0.9% added to 2.5 mg of bupivacaine (0.5 ml) as total volume 1 ml intrathecally Receives: Drug: Saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
the duration and onset of analgesia.
onset of analgesia will be determined as time taken (in minutes) from the administration of intrathecal drug to the patient reporting effective pain relief (e.g. vas score reduction) duration of analgesia will be determined as time ( in minutes) from onset of analgesia until the patient require additional analgesia or reports significant pain (e.g. VAS score above a threshold).
Measured: baseline, pre intervention and after intervention for an average 6 hours
the change in visual analogue scale (VAS) of the labor pain.
change in visual analogue score (VAS) as it is score for measuring pain intensity consisting of 0 to 10 cm line with endpoints labeled as 0 is no pain and 10 is the worst pain and will be evaluated every 5 min for the first 30 min, followed by every 20 min for 3 hours then every 30 min for next 3 hours
Measured: baseline, pre intervention and after intervention an average 6 hours
Secondary outcomes (5)
maternal satisfaction assessed using a satisfaction questionnaire.
it is a questionnaire that has been made according to 5 scale questionnaire as 1-is very dissatisfied 2- dissatisfied 3- neutral 4- satisfied 5- very satisfied.
Measured: At delivery/birth
change in maternal hemodynamics as blood pressure.
Maternal blood pressure will be measured and recorded noninvasively every 5 minutes for the first half hour, followed by every 20 minutes for 3 hours, then every 1 hour for next 3 hours.
a hypotension will be defined as ( decrease in mean ABP more than 25% of the baseline mean ABP).
Measured: baseline, pre intervention and after intervention for an average 6 hours
change in maternal hemodynamics as heart rate
heart rate will be measured and recorded noninvasively every 5 minutes for the first half hour, followed by every 20 minutes for 3 hours, then every 1 hour for next 3 hours. a bradycardia will be defined as (HR less than 50 beats per minute).
Measured: baseline, pre intervention and after intervention for an average 6 hours
change in maternal hemodynamics as respiratory rate.
respiratory rate will be measured and recorded noninvasively every 5 minutes for the first half hour, followed by every 20 minutes for 3 hours, then every 1 hour for next 3 hours. Bradypnea will be defined as respiratory rate below 12 cycle / minute.
Measured: baseline, pre intervention and after intervention for an average 6 hours.
Apgar score at 1 and 5 minutes.
score range 0-10, assessing skin color, heart rate, reflexes, muscle tone, respiratory effort and rate. total score range from 0 to 10. a score of 7 or above indicate good health, while a lower score may require medical attention.
Measured: will be recorded 1 minute after delivery and 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 posted12 Feb 2025
- Study start1 Feb 2025
- Primary completion30 Jun 2025
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaginal DeliveryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jehan George Sadek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jehan George Sadek, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823349
- Sponsor's protocol ID
- Asw.Uni. / 926 / 5 / 24
- Acronym
- SSSA
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eldemrdash AM, Elsawy TTD, Zaher ZZ, Younan JS, Ragheb AMR. Single-Shot Intrathecal Bupivacaine With Fentanyl vs. Dexmedetomidine for Labor Analgesia: A Randomized Controlled Trial. Anesthesiol Res Pract. 2026 Apr 29;2026:6685169. doi: 10.1155/anrp/6685169. eCollection 2026.
PubMed 42063584
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Analgesic Efficacy and Maternal Satisfaction: Single Shot Intrathecal Bupivacaine With Fentanyl Versus Bupivacaine With Dexmedetomidine in Normal Labor, Randomized Control Clinical Trial
- ClinicalTrials.gov ID
- NCT06823349
- Acronym / sponsor ID
- SSSA / Asw.Uni. / 926 / 5 / 24
- Conditions
- Vaginal Delivery, Normal Labor
- Keywords
- painless normal labor, Single shot spinal analgesia in vaginal delivery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Jehan George SadekUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 12 Feb 2025 (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.
the goal of this randomized control trial is to compare the effect of adding fentanyl v.s dexmedetomidine to bupivacaine in single shot spinal analgesia in achievement of analgesia by decreasing visual analogue scale, onset and increasing duration of analgesia in normal labor.
Detailed description
on arrival to the operating room, the demographic and baseline data will be collected, which include sections about age, height, weight, primigravida or multigravida, cervical dilation at the time of performing labor analgesia, fetus presentation, presence of rupture of membrane, baseline pain scores will be assessed using a 10-cm VAS (0 = no pain and 10 = worst imaginable pain) before SSSA. Intravenous access will be achieved in all patients loading will be undertaken using 500 ml Ringer's solution, baseline values of pulse rate (PR), respiratory rate (RR), hemoglobin oxygen saturation (SpO2), and arterial blood pressure (ABP) will be recorded. SSSA will be performed with the parturient in the sitting position under complete aseptic precautions at the L3-L4 level using a 25-gauge spinal needles. The correct positioning of the needle tip in the intrathecal space will be confirmed by the observation of a free flow of cerebrospinal fluid, and then the prefilled study drug will be injected intrathecally which is 2.5 mg bupivacaine plus 25 mic fentanyl or 5 mic dexmedetomidine or 0.5 ml saline according to different groups.
parturient will then turn to the supine position, and a wedge will be placed under the right buttocks to prevent aortocaval compression. VAS will be evaluated every 5 min for the first 30 min, followed by every 20 min for 3 hours then every 30 min for next 3 hours. If VAS 8 or more the instigators will give the patient 50 mg intramuscular pethidine.
Maternal blood pressure, heart rate, respiratory rate, and oxygen saturation will be measured and recorded noninvasively every 5 min for the first half hour, followed by every 20 min for 3 hours, then every 1 h for next 3 hours. the investigators will give 5 mg ephedrine if there is hypotension ( decrease in ABP more than 25% of the baseline ABP) and .5 mg atropine if there is bradycardia (HR less than 50 beats per minute). Side effects such as hypotension, nausea, vomiting, bradycardia, shivering, pruritus, and tachycardia will be recorded. The first- and fifth-minute Apgar scores will also be recorded. The onset, duration of analgesia, and obstetric and neonatal outcomes will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidinethe investigators give 5 mic of dexmedetomidine (0.5 ml) added to 2.5 mg bupivacaine (0.5 ml) as total volume 1 ml intrathecally |
| fentanyl | Active comparator | Drug: fentanylthe investigators give 25 mic of fentanyl (0.5 ml) added to 2.5 mg bupivacaine (0.5 ml) as total volume 1 ml intrathecally |
| Bupivacaine only | Placebo comparator | Drug: Saline 0.9%the investigators give 0.5 ml saline 0.9% added to 2.5 mg of bupivacaine (0.5 ml) as total volume 1 ml intrathecally |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- ASA I-II.
- Uncomplicated pregnancy.
- At term \& singleton fetus.
- Cervical dilatation > 5cm
- Cephalic presentations
Key exclusion criteria (5 listed)
- Patient refusal.
- Bleeding disorders and patients on anticoagulant drugs.
- Infection at site of injection.
- Spine deformity.
- Allergy to any of study medications.
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 |
|---|---|---|
| Dexmedetomidine5 mic dexmedetomidine will be given intrathecally added to 2.5 mg bupivacaine | Drug | Dexmedetomidine |
| fentanyl25 mic of fentanyl will be given intrathecally added to 2.5 mg bupivacaine | Drug | fentanyl |
| Saline 0.9%0.5 ml of saline 0.9% will be given intrathecally added to 2.5 mg of bupivacaine | Drug | Bupivacaine only |
Primary outcome
the duration and onset of analgesia.
Time frame: baseline, pre intervention and after intervention for an average 6 hours
onset of analgesia will be determined as time taken (in minutes) from the administration of intrathecal drug to the patient reporting effective pain relief (e.g. vas score reduction) duration of analgesia will be determined as time ( in minutes) from onset of analgesia until the patient require additional analgesia or reports significant pain (e.g. VAS score above a threshold).
the change in visual analogue scale (VAS) of the labor pain.
Time frame: baseline, pre intervention and after intervention an average 6 hours
change in visual analogue score (VAS) as it is score for measuring pain intensity consisting of 0 to 10 cm line with endpoints labeled as 0 is no pain and 10 is the worst pain and will be evaluated every 5 min for the first 30 min, followed by every 20 min for 3 hours then every 30 min for next 3 hours
5 secondary outcomes
maternal satisfaction assessed using a satisfaction questionnaire.
Time frame: At delivery/birth
change in maternal hemodynamics as blood pressure.
Time frame: baseline, pre intervention and after intervention for an average 6 hours
change in maternal hemodynamics as heart rate
Time frame: baseline, pre intervention and after intervention for an average 6 hours
change in maternal hemodynamics as respiratory rate.
Time frame: baseline, pre intervention and after intervention for an average 6 hours.
Apgar score at 1 and 5 minutes.
Time frame: will be recorded 1 minute after delivery and 5 minutes after delivery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Derived from this study: PubMed 42063584Eldemrdash AM, Elsawy TTD, Zaher ZZ, Younan JS, Ragheb AMR. Single-Shot Intrathecal Bupivacaine With Fentanyl vs. Dexmedetomidine for Labor Analgesia: A Randomized Controlled Trial. Anesthesiol Res Pract. 2026 Apr 29;2026:6685169. doi: 10.1155/anrp/6685169. eCollection 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine, fentanyl and Saline 0.9% in people with Vaginal Delivery and Normal Labor, run by Jehan George Sadek 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 31 Jul 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jehan G Younan, resident doctor. (+20 01222333194, jehan.younan1995@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the duration and onset of analgesia. (time frame: baseline, pre intervention and after intervention for an average 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06823349, which also lists 1 linked publication.
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 31 Jul 2025.