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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00707824
Other study ID # 110/2000
Secondary ID
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


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
See also
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Terminated NCT03695172 - Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section Phase 4
Recruiting NCT06247852 - Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study
Completed NCT06012747 - Pain After Cesarean Section - A Danish Multicenter Cohort Study.
Not yet recruiting NCT05187520 - Naldebain for Control of Post-Cesarean Section Pain Phase 2
Not yet recruiting NCT04999670 - Fascial Closure and Post-caesarean Pain N/A