Epidural Nalbuphine for Postcesarean Epidural Morphine Induced Pruritus

Mahidol University

Status and phase: Completed; Phase 4

Conditions: Cesarean Section

Treatments: Drug: nalbuphine; Other: NSS

Study type: Interventional

Funder types: Other

Identifiers

NCT00707824

110/2000

Details and patient eligibility

About

Can epidural nalbuphine reduce incidence or severity of epidural morphine induced pruritus in patient undergoing cesarean section?

Full description

182 parturients,ASA 1-2 undergoing cesarean section under epidural block were enrolled in the study. After obtaining informed consent,all received epidural anesthesia using 2% lidocaine with epinephrine 1:200000 via epidural cathetes at L2-3 or L3-4 in a volume suffient to achieve a T4 sensory level bilaterally.

After the umbilical cord was clamped,patients were assigned randomly to three groups.The placebo group,N-5 group,and N-10 group received 4 ml epidural solution containing morphine 4 mg plus either saline, nalbuphine 5 mg, and nalbuphine 10 mg respectively.At the post anesthetic care unit, intravenous pethidine PCA were administered for inadequate pain control.

Outcome measures :

Incidence and severity of postoperative pruritus Quality of pain control Side effects of epidural morphine and nalbuphine such as respiratory depression,sedation

Enrollment: 165 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• full term parturient undergoing elective cesarean section
• ASA 1-2

Exclusion criteria

• drug or alcohol abuses
• contraindication for regional anesthesia
• received opioids within 12 hours

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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165 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

1= placebo

Treatment:

Other: NSS

2

Active Comparator group

Description:

2=nalbuphine 5 mg

Treatment:

Drug: nalbuphine

Drug: nalbuphine

3

Active Comparator group

Description:

3=nalbuphine 10 mg

Treatment:

Drug: nalbuphine

Drug: nalbuphine