Different Lipid Soluble Opioids for Gynecologic Laparoscopic Surgery Postoperative Patient-controlled Analgesia

Post Operative Pain Management Clinical Trial

Official title:

Different Lipid Soluble Opioids for Gynecologic Laparoscopic Surgery Postoperative Patient-controlled Analgesia --- a Double Blind Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01917045
• Other study ID #: LSOPCA-021
• Status: Completed
• Phase: N/A
• First received: June 14, 2013
• Last updated: August 3, 2013
• Start date: January 2012
• Est. completion date: March 2013

Study information

• Verified date: August 2013
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The investigators noticed that Body Fat Ratio might have great influence on the efficacy of different lipid soluble anesthetics. The objective of this clinical trial was to compare the effect of that Body Fat Ratio on the efficacy of different lipid soluble anesthetics.

Description:

The objective of this clinical trial was to compare the effect of that Body Fat Ratio on the efficacy of different lipid soluble anesthetics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists grade I-II

• adults aged over 20 and below 50 years old,

• non-smoker,

• with normal hepatic and renal function.

Exclusion Criteria:

• smoker ,

• any kind of mental disorder or

• history use of analgesics for more than 10 consecutive days,

• asthma; and

• those with digestion tract disorder who would get nausea or vomiting much more easily than normal people.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain Management

Intervention

Drug:
• Sufentanil (R30730, brand name Sufenta)
sufentanil 1ug/ml
• Sufentanil (R30730, brand name Sufenta) + Morphine
sufentanil 0.5ug/ml+morphine 0.25mg/ml
• Morphine
morphine 0. 5mg/ml

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analogue pain scores	we evaluate visual analogue pain scores at different time points within 24 hours after surgery	24hour	No
Secondary	nausea & vomiting	we evaluate nausea & vomiting at different time points within 24 hours after surgery. we ask the patient if she feel nausea or/and occured vomit, if so, 1 time will be recorded in the time point for incidence.	24hour	No