Cesarean SectionPhase 4NCT07921511
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
A Phase 4 study testing Dexmedetomidine, morphine and Bupivacaine in people with Cesarean Section, run by Assiut University.
Trial summary
The aim of the work is to investigate the effect of dexmedetomidine on postoperative analgesia in spinal anesthesia for cesarean section at Assuit University Hospital Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Dexmedetomidine, morphine and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2024to 30 Dec 2027
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy (ASA I, II)
- 18-45 year-old
- full term pregnant women
Who cannot join
- 1. Placenta praevia 2. Opioid agonist/antagonist administration in the preceding 6 h (or within 1 h if given intravenously) 3. History of bleeding diathesis 4. History or presence of cardiac, respiratory, hepatic, and/or renal failures 5. Those who had contraindications to neuraxial block
About this study
The aim of the work is to investigate the effect of dexmedetomidine on postoperative analgesia in spinal anesthesia for cesarean section at Assuit University Hospital
Read the detailed description
Brief Title Effect of Dexmedetomidine on Postoperative Pain After Cesarean Section
Official Title Effect of Intrathecal Dexmedetomidine as an Adjuvant to Hyperbaric Bupivacaine on Postoperative Analgesia in Women Undergoing Elective Cesarean Section: A Randomized, Double-Blind, Controlled Trial
Brief Summary Pain after cesarean section can delay recovery, mobilization, and breastfeeding. This study will evaluate whether adding dexmedetomidine to spinal bupivacaine prolongs postoperative analgesia and reduces opioid use in women undergoing elective cesarean section, and will assess maternal hemodynamic effects and side effects.
Detailed Description Cesarean section is one of the most common surgical procedures worldwide, and effective postoperative analgesia is essential for maternal recovery and newborn care. Spinal anesthesia is the standard technique, but the analgesic effect of local anesthetic alone is limited to a few hours, and opioid adjuvants are associated with nausea, vomiting, pruritus, and respiratory depression.
Dexmedetomidine is a highly selective alpha-2 adrenergic agonist with sedative and analgesic properties. When given intrathecally, it prolongs sensory and motor block and may reduce postoperative analgesic requirements. Its safety and optimal use in obstetric patients, including hemodynamic effects such as hypotension and bradycardia, require further evaluation.
This is a prospective, randomized, double-blind, controlled trial that will enroll [number] women aged [18-40] years, ASA physical status II, scheduled for elective cesarean section under spinal anesthesia at [hospital/department, Assiut, Egypt]. Participants will be randomly allocated in a [1:1] ratio, using [computer-generated randomization with sealed opaque envelopes], to:
Group D: hyperbaric bupivacaine 0.5% [dose] mg plus intrathecal dexmedetomidine [dose] mcg Group C: hyperbaric bupivacaine 0.5% [dose] mg plus intrathecal normal saline in the same volume
The study drug will be prepared by an anesthesiologist not involved in patient assessment, so patients and outcome assessors remain blinded. All patients will receive the same standardized anesthetic and multimodal analgesic protocol, with [paracetamol/NSAID] postoperatively and rescue analgesia with [drug and dose] on request.
Pain will be assessed with the Visual Analogue Scale (VAS 0-10) at rest and on movement at [0, 2, 4, 6, 12, and 24] hours. Heart rate, blood pressure, oxygen saturation, sedation level (Ramsay score), and sensory and motor block characteristics will be recorded at fixed intervals. Adverse events (hypotension, bradycardia, nausea, vomiting, pruritus, shivering) will be documented and treated per protocol. Neonatal outcomes (Apgar scores at 1 and 5 minutes) will also be recorded.
Data will be analyzed with [SPSS], using appropriate parametric or non-parametric tests, with p < 0.05 considered significant.
Conditions Postoperative Pain; Cesarean Section Complications
Keywords Dexmedetomidine; cesarean section; spinal anesthesia; postoperative analgesia; bupivacaine
Study Type / Phase Interventional; Phase 4 (or Phase 2/3, depending on your regulatory status)
Allocation / Masking / Model Randomized; Parallel assignment; Masking: Double (Participant, Outcomes Assessor), or Triple if the investigator is also blinded
Primary Outcome Duration of effective analgesia, defined as time from spinal injection to first request for rescue analgesia (or VAS ≥ 4) [up to 24 hours]
Secondary Outcomes
Pain scores (VAS) at rest and on movement over 24 hours Total 24-hour consumption of rescue analgesic Onset and duration of sensory and motor block Hemodynamic changes: hypotension and bradycardia incidence Sedation score Maternal side effects (nausea, vomiting, pruritus, shivering) Neonatal Apgar scores at 1 and 5 minutes Maternal satisfaction
Eligibility Inclusion: Female, age [18-40]; term singleton pregnancy; elective cesarean under spinal anesthesia; ASA II; informed consent.
Exclusion: Contraindication to spinal anesthesia; allergy to study drugs; severe preeclampsia or cardiovascular disease; baseline bradycardia or heart block; chronic opioid or sedative use; BMI [>40]; emergency surgery; failed spinal or conversion to general anesthesia.
- Conditions
- Cesarean Section
- Being tested
- Dexmedetomidine, morphine, Bupivacaine, Epinephrine, Diclofenac
- Keywords
- Dexmedetomidine in cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
parturients undergoing elective cesarean section, who will randomly be distributed into two groups. Group A will receive 12 mg bupivacaine, Group B will receive additional 3 μg dexmedetomidine to bupivacaine
morphineDrug
parturients undergoing elective cesarean section, who will randomly be distributed into two groups. Group A will receive 12 mg bupivacaine, Group B will receive additional 3 μg dexmedetomidine to bupivacaine
BupivacaineDrug
Also called Marcaine Spinal
Hyperbaric bupivacaine 0.5%, [dose] mg intrathecal, single dose for spinal anesthesia in all participants
EpinephrineDrug
[Dose] IV given if hypotension occurs (systolic blood pressure < [80%] of baseline).
DiclofenacDrug
given on request when VAS ≥ 4 during the first 12hours
| Study group | Role | What they receive |
|---|---|---|
| patient take dexmedetomidine intrathecal and record pain post-operativly | Active comparator | Not described Receives: Drug: Dexmedetomidine; Drug: Bupivacaine; Drug: Epinephrine; Drug: Diclofenac |
| patient take morphine intrathecal | Placebo comparator | parturients undergoing elective cesarean section, who will randomly be distributed into two groups. Group A will receive 12 mg bupivacaine, Group B will receive additional 3 μg dexmedetomidine to bupivacaine Receives: Drug: morphine; Drug: Bupivacaine; Drug: Epinephrine; Drug: Diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Postoperative pain were assessed by 6-point verbal rating scale (VRS), includes the descriptors "No pain", "Very mild pain," "Mild pain," "Moderate pain," "Severe pain," and "Very severe pain", in which 0 represented no pain and 5 represented worst possible pain. VRS will be measured 6 and 12 hr postoperatively by an anesthesiaologist who was unaware of the patient allocation group
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start10 Nov 2024
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Assiut 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Gamal Nouby, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921511
- Sponsor's protocol ID
- Dexmed in cesarean section
- Status last verified
- Nov 2026
- First submitted
- 20 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qi X, Chen D, Li G, Huang X, Li Y, Wang X, Li Y. Comparison of Intrathecal Dexmedetomidine with Morphine as Adjuvants in Cesarean Sections. Biol Pharm Bull. 2016 Sep 1;39(9):1455-60. doi: 10.1248/bpb.b16-00145. Epub 2016 Jun 28.
PubMed 27349272Mo X, Huang F, Wu X, Feng J, Zeng J, Chen J. Intrathecal dexmedetomidine as an adjuvant to plain ropivacaine for spinal anesthesia during cesarean section: a prospective, double-blinded, randomized trial for ED50 determination using an up-down sequential allocation method. BMC Anesthesiol. 2023 Sep 25;23(1):325. doi: 10.1186/s12871-023-02275-x.
PubMed 37749533
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
- ClinicalTrials.gov ID
- NCT07921511
- Acronym / sponsor ID
- Dexmed in cesarean section
- Conditions
- Cesarean Section
- Keywords
- Dexmedetomidine in cesarean section
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Nov 2024 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 6 Nov 2026 (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 aim of the work is to investigate the effect of dexmedetomidine on postoperative analgesia in spinal anesthesia for cesarean section at Assuit University Hospital
Detailed description
Brief Title Effect of Dexmedetomidine on Postoperative Pain After Cesarean Section
Official Title Effect of Intrathecal Dexmedetomidine as an Adjuvant to Hyperbaric Bupivacaine on Postoperative Analgesia in Women Undergoing Elective Cesarean Section: A Randomized, Double-Blind, Controlled Trial
Brief Summary Pain after cesarean section can delay recovery, mobilization, and breastfeeding. This study will evaluate whether adding dexmedetomidine to spinal bupivacaine prolongs postoperative analgesia and reduces opioid use in women undergoing elective cesarean section, and will assess maternal hemodynamic effects and side effects.
Detailed Description Cesarean section is one of the most common surgical procedures worldwide, and effective postoperative analgesia is essential for maternal recovery and newborn care. Spinal anesthesia is the standard technique, but the analgesic effect of local anesthetic alone is limited to a few hours, and opioid adjuvants are associated with nausea, vomiting, pruritus, and respiratory depression.
Dexmedetomidine is a highly selective alpha-2 adrenergic agonist with sedative and analgesic properties. When given intrathecally, it prolongs sensory and motor block and may reduce postoperative analgesic requirements. Its safety and optimal use in obstetric patients, including hemodynamic effects such as hypotension and bradycardia, require further evaluation.
This is a prospective, randomized, double-blind, controlled trial that will enroll [number] women aged [18-40] years, ASA physical status II, scheduled for elective cesarean section under spinal anesthesia at [hospital/department, Assiut, Egypt]. Participants will be randomly allocated in a [1:1] ratio, using [computer-generated randomization with sealed opaque envelopes], to:
Group D: hyperbaric bupivacaine 0.5% [dose] mg plus intrathecal dexmedetomidine [dose] mcg Group C: hyperbaric bupivacaine 0.5% [dose] mg plus intrathecal normal saline in the same volume
The study drug will be prepared by an anesthesiologist not involved in patient assessment, so patients and outcome assessors remain blinded. All patients will receive the same standardized anesthetic and multimodal analgesic protocol, with [paracetamol/NSAID] postoperatively and rescue analgesia with [drug and dose] on request.
Pain will be assessed with the Visual Analogue Scale (VAS 0-10) at rest and on movement at [0, 2, 4, 6, 12, and 24] hours. Heart rate, blood pressure, oxygen saturation, sedation level (Ramsay score), and sensory and motor block characteristics will be recorded at fixed intervals. Adverse events (hypotension, bradycardia, nausea, vomiting, pruritus, shivering) will be documented and treated per protocol. Neonatal outcomes (Apgar scores at 1 and 5 minutes) will also be recorded.
Data will be analyzed with [SPSS], using appropriate parametric or non-parametric tests, with p < 0.05 considered significant.
Conditions Postoperative Pain; Cesarean Section Complications
Keywords Dexmedetomidine; cesarean section; spinal anesthesia; postoperative analgesia; bupivacaine
Study Type / Phase Interventional; Phase 4 (or Phase 2/3, depending on your regulatory status)
Allocation / Masking / Model Randomized; Parallel assignment; Masking: Double (Participant, Outcomes Assessor), or Triple if the investigator is also blinded
Primary Outcome Duration of effective analgesia, defined as time from spinal injection to first request for rescue analgesia (or VAS ≥ 4) [up to 24 hours]
Secondary Outcomes
Pain scores (VAS) at rest and on movement over 24 hours Total 24-hour consumption of rescue analgesic Onset and duration of sensory and motor block Hemodynamic changes: hypotension and bradycardia incidence Sedation score Maternal side effects (nausea, vomiting, pruritus, shivering) Neonatal Apgar scores at 1 and 5 minutes Maternal satisfaction
Eligibility Inclusion: Female, age [18-40]; term singleton pregnancy; elective cesarean under spinal anesthesia; ASA II; informed consent.
Exclusion: Contraindication to spinal anesthesia; allergy to study drugs; severe preeclampsia or cardiovascular disease; baseline bradycardia or heart block; chronic opioid or sedative use; BMI [>40]; emergency surgery; failed spinal or conversion to general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient take dexmedetomidine intrathecal and record pain post-operativly | Active comparator | Drug: Dexmedetomidine, Drug: Bupivacaine, Drug: Epinephrine, Drug: Diclofenac |
| patient take morphine intrathecal | Placebo comparator | Drug: morphine, Drug: Bupivacaine, Drug: Epinephrine, Drug: Diclofenacparturients undergoing elective cesarean section, who will randomly be distributed into two groups. Group A will receive 12 mg bupivacaine, Group B will receive additional 3 μg dexmedetomidine to bupivacaine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy (ASA I, II)
- 18-45 year-old
- full term pregnant women
Key exclusion criteria (1 listed)
- 1. Placenta praevia 2. Opioid agonist/antagonist administration in the preceding 6 h (or within 1 h if given intravenously) 3. History of bleeding diathesis 4. History or presence of cardiac, respiratory, hepatic, and/or renal failures 5. Those who had contraindications to neuraxial block
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 |
|---|---|---|
| Dexmedetomidineparturients undergoing elective cesarean section, who will randomly be distributed into two groups. Group A will receive 12 mg bupivacaine, Group B will receive additional 3 μg dexmedetomidine to bupivacaine | Drug | patient take dexmedetomidine intrathecal and record pain post-operativly |
| morphineparturients undergoing elective cesarean section, who will randomly be distributed into two groups. Group A will receive 12 mg bupivacaine, Group B will receive additional 3 μg dexmedetomidine to bupivacaine | Drug | patient take morphine intrathecal |
| BupivacaineAlso: Marcaine SpinalHyperbaric bupivacaine 0.5%, [dose] mg intrathecal, single dose for spinal anesthesia in all participants | Drug | patient take dexmedetomidine intrathecal and record pain post-operativly, patient take morphine intrathecal |
| Epinephrine[Dose] IV given if hypotension occurs (systolic blood pressure < [80%] of baseline). | Drug | patient take dexmedetomidine intrathecal and record pain post-operativly, patient take morphine intrathecal |
| Diclofenacgiven on request when VAS ≥ 4 during the first 12hours | Drug | patient take dexmedetomidine intrathecal and record pain post-operativly, patient take morphine intrathecal |
Primary outcome
Postoperative pain
Time frame: 12 hours
Postoperative pain were assessed by 6-point verbal rating scale (VRS), includes the descriptors "No pain", "Very mild pain," "Mild pain," "Moderate pain," "Severe pain," and "Very severe pain", in which 0 represented no pain and 5 represented worst possible pain. VRS will be measured 6 and 12 hr postoperatively by an anesthesiaologist who was unaware of the patient allocation group
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 6 Nov 2026.
- Results publication: PubMed 27349272Qi X, Chen D, Li G, Huang X, Li Y, Wang X, Li Y. Comparison of Intrathecal Dexmedetomidine with Morphine as Adjuvants in Cesarean Sections. Biol Pharm Bull. 2016 Sep 1;39(9):1455-60. doi: 10.1248/bpb.b16-00145. Epub 2016 Jun 28.
- Results publication: PubMed 37749533Mo X, Huang F, Wu X, Feng J, Zeng J, Chen J. Intrathecal dexmedetomidine as an adjuvant to plain ropivacaine for spinal anesthesia during cesarean section: a prospective, double-blinded, randomized trial for ED50 determination using an up-down sequential allocation method. BMC Anesthesiol. 2023 Sep 25;23(1):325. doi: 10.1186/s12871-023-02275-x.
- Related InfoLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine, morphine and Bupivacaine in people with Cesarean Section, run by Assiut University.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. 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. 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?
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?
Postoperative pain (time frame: 12 hours). 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 NCT07921511, which also lists 2 linked publications.
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 6 Nov 2026.