Skip to content

Epidural Nalbuphine for Postcesarean Epidural Morphine Induced Pruritus

Study of Epidural Nalbuphine for Prevention of Epidural Morphine Induced Pruritus

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00707824
Enrollment
165
Registered
2008-07-01
Start date
2000-06-30
Completion date
2006-02-28
Last updated
2008-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section

Keywords

pruritus, epidural morphine

Brief summary

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

Detailed 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

Interventions

DRUGnalbuphine

nalbuphine 5 mg epidural

OTHERNSS

NSS

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
incidence and severity of pruritus24 hr

Secondary

MeasureTime frame
visual analogue pain score24 hr

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026