Epidural Nalbuphine for Postcesarean Epidural Morphine Induced Pruritus

Cesarean Section Clinical Trial

Official title:

Study of Epidural Nalbuphine for Prevention of Epidural Morphine Induced Pruritus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00707824
• Other study ID #: 110/2000
• Status: Completed
• Phase: Phase 4
• First received: June 29, 2008
• Last updated: July 7, 2008
• Start date: June 2000
• Est. completion date: February 2006

Study information

• Verified date: February 2006
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: February 2006
• Est. primary completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cesarean Section
• Pruritus

Intervention

Drug:
• nalbuphine
nalbuphine 5 mg epidural
• nalbuphine
nalbuphine 10 mg epidural

Other:
• NSS
NSS

Locations

Country	Name	City	State
Thailand	Mahidol University	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence and severity of pruritus		24 hr	Yes
Secondary	visual analogue pain score		24 hr	Yes