Postoperative PainPhase 4BATPCAHNCT00510666
Comparison of Butorphanol and Tramadol Associated Patient-Controlled Analgesia (PCA) After Hysterectomy
A Phase 4 study testing Saline, Butorphanol tartrate and Tramadol Hydrochloride in people with Postoperative Pain and Hysterectomy, run by Nanjing Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 64 years, women only
- Conditions the study is for
- Postoperative Pain, Hysterectomy
- What is being tested?
- Saline, Butorphanol tartrate and Tramadol Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 841 participants
- Where
- 1 siteChina
- Study dates
- Jan 2007to May 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status I-II
- Chinese
- 19-64yr
- Uterus myoma
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Postoperative Pain, Hysterectomy
- Being tested
- Saline, Butorphanol tartrate, Tramadol Hydrochloride
- Keywords
- Pain, Postoperative, Analgesics, Opioid, Analgesia, Patient-Controlled, Pain Measurement
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
Also called SA
Saline infusion adjunct to morphine PCA pump
Butorphanol tartrateDrug
Also called BT
Butorphanol was delivered at a continuous infusion manner adjunct to morphine PCA pump
Tramadol HydrochlorideDrug
Also called TH
100mg tramadol was used preemptively to morphine PCA pump
SalineDrug
Also called PS
Preemptive saline as a control group to tramadol one
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Butorphanol basal infusion adjunct to morphine PCA Receives: Drug: Butorphanol tartrate |
| 2 | Experimental | Saline infusion adjunct to morphine PCA Receives: Drug: Saline |
| 3 | Experimental | Premedication of Tramadol Receives: Drug: Tramadol Hydrochloride |
| 4 | Experimental | Preemptive saline for morphine PCA Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain scoring;
Measured: 5 months
Secondary outcomes (1)
VAS sedation scoring; VAS happiness scoring; Adverse effects; Patient's overall conditions.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2007 (estimated)
- Study startJan 2007
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 841 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau
- Investigators
- XiaoFeng Shen, MD, Study chair, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510666
- Sponsor's protocol ID
- NMU-2579-3FW
- Other IDs
- NMU2007092
- Acronym
- BATPCAH
- Status last verified
- Mar 2009
- First submitted
- 1 Aug 2007
- Last updated
- 31 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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. doi: 10.1097/EJA.0b013e32831a6aa2.
PubMed 19122548
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Butorphanol and Tramadol for Morphine PCA Pain Management After Total Hysterectomy
- ClinicalTrials.gov ID
- NCT00510666
- Acronym / sponsor ID
- BATPCAH / NMU-2579-3FW
- Conditions
- Postoperative Pain, Hysterectomy
- Keywords
- Pain, Postoperative, Analgesics, Opioid, Analgesia, Patient-Controlled, Pain Measurement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 841 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau
- Study start
- Jan 2007
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 2 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Butorphanol tartrateButorphanol basal infusion adjunct to morphine PCA |
| 2 | Experimental | Drug: SalineSaline infusion adjunct to morphine PCA |
| 3 | Experimental | Drug: Tramadol HydrochloridePremedication of Tramadol |
| 4 | Experimental | Drug: SalinePreemptive saline for morphine PCA |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA physical status I-II
- Chinese
- 19-64yr
- Uterus myoma
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SalineAlso: SASaline infusion adjunct to morphine PCA pump | Drug | 2 |
| Butorphanol tartrateAlso: BTButorphanol was delivered at a continuous infusion manner adjunct to morphine PCA pump | Drug | 1 |
| Tramadol HydrochlorideAlso: TH100mg tramadol was used preemptively to morphine PCA pump | Drug | 3 |
| SalineAlso: PSPreemptive saline as a control group to tramadol one | Drug | 4 |
Primary outcome
VAS pain scoring;
Time frame: 5 months
1 secondary outcome
VAS sedation scoring; VAS happiness scoring; Adverse effects; Patient's overall conditions.
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2009.
- Results publication: PubMed 19122548Wang 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. doi: 10.1097/EJA.0b013e32831a6aa2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
XiaoFeng Shen, MD study chair
Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Saline, Butorphanol tartrate and Tramadol Hydrochloride in people with Postoperative Pain and Hysterectomy, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS pain scoring; (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00510666, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2009.