Adding dexmedetomidine to bupivacaine for a dural‑puncture epidural in labor
The Effect of Different Doses of Dexmedetomidine as an Adjuvant to Bupivacaine for Parturients Having Dural Puncture Epidural Technique to Elaborate Labor Pain
This trial tests whether adding small doses of dexmedetomidine to epidural bupivacaine during a dural‑puncture technique reduces the total bupivacaine needed and improves pain control for women in active labor.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Menoufia University Academic / other |
| Locations | 1 site (Shebeen El Kom) |
| Trial ID | NCT07506044 on ClinicalTrials.gov |
What this trial studies
Pregnant women in active labor who meet inclusion criteria receive a dural‑puncture epidural and are given bupivacaine with or without added dexmedetomidine at two different doses. The primary outcome is the total bupivacaine dose used during labor. Secondary outcomes include pain scores (VAS), number of additional doses given, incidence of motor block, delivery mode, maternal satisfaction, and complications such as hypotension, fetal bradycardia, and epidural‑related fever. The protocol compares groups receiving dexmedetomidine 0.4, dexmedetomidine 0.6, and standard bupivacaine management to see if the adjuvant reduces drug use or improves clinical outcomes.
Who should consider this trial
Good fit: Women in active labor (cervical dilation about 3–5 cm) with a normally positioned singleton fetus, intact membranes, and no exclusion criteria are ideal candidates.
Not a fit: People with abnormal fetal presentation or lie, premature rupture of membranes, maternal fever, fetal distress, pregnancy‑induced diseases, abnormal placental position, ASA grade > II, marked obesity, drug allergies, spinal deformity, or infection at the injection site would not be appropriate and are unlikely to benefit.
Why it matters
Potential benefit: If successful, adding dexmedetomidine could lower the total bupivacaine needed during labor and improve pain control with similar or fewer side effects.
How similar studies have performed: Previous neuraxial anesthesia studies have shown that dexmedetomidine can have analgesic‑sparing effects, but its specific use with dural‑puncture epidural for labor is less well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women who attend the Emergency Department in labor, with cervical dilation of 3-5 cm, * normally presented singleton fetus, intact fetal membranes, and who are free of exclusion criteria Exclusion Criteria: Abnormal fetal presentation or lie, 'premature rupture of membranes, maternal fever, fetal distress, pregnancy-induced diseases * abnormal placental position, * ASA grade\>II * marked obesity, * allergy or contraindications to the used drugs, * spinal deformity or disorders 'cutaneous diseases or infection at the injection site
Where this trial is running
Shebeen El Kom
- Faculty of Medicine Menoufia University — Shebeen El Kom, Egypt (Recruiting)
Study contacts
- Study coordinator: Rabab Habeeb, MD
- Email: rabab_habeeb@med.menofia.edu.eg
- Phone: +201001970973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.