Postoperative Pain Control by Use of Many Drugs in Small Doses Intrathecally

Sohag University

Status and phase: Unknown; Phase 2

Conditions: Post Operative Pain

Treatments: Drug: Morphine Sulfate; Drug: Bupivacaine; Drug: dexamethasone, morphine, midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT05186454

2008

Details and patient eligibility

About

Cesarean section is one of the painful operations that require adequate postoperative analgesia. Patients are divided into two groups: Multimodal (DMM) group ( 30 patients): patients will receive spinal anesthesia with 10-12.5 mg bupivacaine and 1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam.

Morphine (M) group (30 patients): patients will receive spinal anesthesia with 10-12.5 mg bupivacaine and 1 ml containing 200 µg morphine

Enrollment: 60 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA I-II
• Age 20-40 years.
• Pregnant women with living fetus.
• Body mass index 20- 35 kg/m2.

Exclusion criteria

• Patient refusal.
• Age < 20 or > 40 years
• Body mass index < 20 or > 35.
• Contraindication to spinal anesthesia (severe mitral or aortic stenosis, coagulopathy, Systemic or local infection, increased intracranial pressure and hypovolemia).
• Placental abnormalities: placental abruption, placenta previa or accrete.
• Allergy to drugs used in the study.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Morphine

Active Comparator group

Description:

Patients will receive 10-12.5 mg bupivacaine and 1 ml containing 200 µg of morphine intrathecally.

Treatment:

Drug: Bupivacaine

Drug: Morphine Sulfate

Multimodal

Active Comparator group

Description:

Patients will receive 10-12.5 mg bupivacaine and 1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam intrathecally

Treatment:

Drug: Bupivacaine

Drug: dexamethasone, morphine, midazolam