A Phase 4 interventional study of Dexmedetomidine and morphine in Cesarean Section, sponsored by Assiut University. Active, not recruiting. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Assiut University · Phase 4, Interventional, and Treatment
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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
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.
Assiut University is the lead sponsor of 5,081 studies on the registry; 2,179 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Dexmedetomidine · Drug: Bupivacaine · Drug: Epinephrine · Drug: Diclofenac
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
Drug: morphine · Drug: Bupivacaine · Drug: Epinephrine · Drug: Diclofenac
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
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
Hyperbaric bupivacaine 0.5%, \[dose\] mg intrathecal, single dose for spinal anesthesia in all participants
Also known as: Marcaine Spinal
\[Dose\] IV given if hypotension occurs (systolic blood pressure \< \[80%\] of baseline).
given on request when VAS ≥ 4 during the first 12hours
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
Time frame: 12 hours
No study locations are listed for this record.
Plan to share: No
Started Nov 2024 (actual). Primary completion is estimated for Aug 2027, 33 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexmedetomidine