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NCT Number: NCT00707824

Epidural Nalbuphine for Postcesarean Epidural Morphine Induced Pruritus

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

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Key information

Conditions

Cesarean Section Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nalbuphine

Drug

nalbuphine 5 mg epidural

Other names: nubain

NSS

Other

NSS

Other names: nornal saline

Primary outcomes

  1. incidence and severity of pruritus

    Time frame: 24 hr

Secondary outcomes

  1. visual analogue pain score

    Time frame: 24 hr

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Study of Epidural Nalbuphine for Prevention of Epidural Morphine Induced Pruritus

Important dates

Study start
2000
Primary completion
2005
Study completion
2006
First posted
Jul 1, 2008
Registry last updated
Jul 8, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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