Study of Epidural Nalbuphine for Prevention of Epidural Morphine Induced Pruritus
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Mahidol University
- Enrollment
- 165
- Locations
- 1
- Primary Endpoint
- incidence and severity of pruritus
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •full term parturient undergoing elective cesarean section
Exclusion Criteria
- •drug or alcohol abuses
- •contraindication for regional anesthesia
- •received opioids within 12 hours
Arms & Interventions
1
1= placebo
Intervention: NSS (Other)
2
2=nalbuphine 5 mg
Intervention: nalbuphine (Drug)
3
3=nalbuphine 10 mg
Intervention: nalbuphine (Drug)
Outcomes
Primary Outcomes
incidence and severity of pruritus
Time Frame: 24 hr
Secondary Outcomes
- visual analogue pain score(24 hr)