| August 1, 2007 |
| March 30, 2009 |
| January 2007 |
| May 2007 (final data collection date for primary outcome measure) |
| VAS pain scoring; [ Time Frame: 5 months ] [ Designated as safety issue: Yes ] |
| VAS pain scoring; [ Time Frame: 5 months ] |
| Complete list of historical versions of study NCT00510666 on ClinicalTrials.gov Archive Site |
| VAS sedation scoring;
VAS happiness scoring;
Adverse effects;
Patient's overall conditions. [ Time Frame: 5 months ] [ Designated as safety issue: Yes ] |
| VAS sedation scoring;
VAS happiness scoring;
Adverse effects. [ Time Frame: 5 months ] |
| |
| Comparison of Butorphanol and Tramadol Associated Patient-Controlled Analgesia (PCA) After Hysterectomy |
| Butorphanol and Tramadol for Morphine PCA Pain Management After Total Hysterectomy |
Intravenous patient-controlled analgesia (PCA) is a popular technique for postoperative pain management. Although several drugs are recognized as effective therapeutic options, optimal selection of drugs in hysterectomy patients underwent different anesthesia treatments remains unknown explicitly. The investigators hypothesized that butorphanol and tramadol can produce different analgesic effects with intravenous PCA after abdominal hysterectomy. |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
- Postoperative Pain
- Hysterectomy
|
- Drug: Saline
- Drug: Butorphanol tartrate
- Drug: Tramadol Hydrochloride
|
- Experimental: Butorphanol basal infusion adjunct to morphine PCA
- Experimental: Saline infusion adjunct to morphine PCA
- Experimental: Premedication of Tramadol
- Experimental: Preemptive saline for morphine PCA
|
| Wang F, Shen X, Liu Y, Xu S, Guo X. Continuous infusion of butorphanol combined with intravenous morphine patient-controlled analgesia after total abdominal hysterectomy: a randomized, double-blind controlled trial. Eur J Anaesthesiol. 2009 Jan;26(1):28-34. |
| |
| Completed |
| 841 |
| May 2007 |
| May 2007 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- ASA physical status I-II
- Chinese
- 19-64yr
- Uterus myoma
Exclusion Criteria:
- Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records.
- Participants younger than 18yr，older than 65yr or pregnancy was eliminated.
- Due to the significant changes in vital signs might affect cognition of pain and that of sensation, over 20% variation of these records from the baselines or below 92% of SpO2 under 20-40% nasal tube oxygen at any time should be excluded from the study.
- Those who were not willing to or could not finish the whole study at any time.
- Any patient who exhibited a combative or incoherent state of PCA analgesia would be excluded from the study.
- Allergy to local anesthetics.
- Failed to perform the epidural catheterization.
- Those who demonstrated significant nerve-associated side effects from the insertion of the epidural needle.
|
| Female |
| 19 Years to 64 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| China |
| |
| NCT00510666 |
| XiaoFeng Shen, Nanjing Maternal and Child Health Hospital |
| NMU-2579-3FW, NMU2007092 |
| Nanjing Medical University |
| HRSA/Maternal and Child Health Bureau |
| Study Chair: |
XiaoFeng Shen, MD |
Nanjing Medical University |
|
|
| Nanjing Medical University |
| March 2009 |
