PainPhase 4NCT02114463
Comparison of Two Kinds of Postoperative Analgesia After Amputation
A Phase 4 study testing Local analgesic, Intravenous analgesic and ropivacaine in people with Pain and Complications, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.
Trial summary
Pain after amputation is a significant problem among amputees. Phantom limb pain may appear in up to 85% of patients and is usually resistant to a wide variety of treatments.It is believed that regional anesthesia, by preventing the establishment of central sensitization, may play a role in reducing the incidence of… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Complications
- What is being tested?
- Local analgesic, Intravenous analgesic and ropivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- Mar 2014to Aug 2016
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of American Association of anesthetists（ASA）Grade 1 or 2
- Aged between 18 and 65 years
- Undergoing elective total knee replacement
Who cannot join
- Mental illness can not match
- Nerve block, epidural anesthesia contraindicated
- People who have Slow-type arrhythmias
- History of chronic headaches and long-term use of analgesic drugs
- People who were postoperative consciousness, language or hearing impaired
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou Military Region General Hospital, Department of Anesthesiology
Guangzhou, Guangdong, 510010
Dong Xu Zhou, 13268260337 ext. 86, 13268260337@163.com
About this study
Official title: Comparison of Two Kinds of Postoperative Analgesia After Amputation:a Randomized Clinical Trial
Pain after amputation is a significant problem among amputees. Phantom limb pain may appear in up to 85% of patients and is usually resistant to a wide variety of treatments.It is believed that regional anesthesia, by preventing the establishment of central sensitization, may play a role in reducing the incidence of acute and chronic pain. Therefore the investigators will compare two methods of postoperative analgesic after after amputation by their efficiency and complication.
Read the detailed description
Peripheral nerve transection results in an afferent nociceptive barrage that initiates spinal cord hyperexcitability with expansion of the receptive fields of dorsal horn neurons that respond to the nearest intact afferents. These neuroplastic changes are believed to be responsible for the development of postsurgical chronic pain syndromes, including phantom limb and stump pain.At present, there are no randomized studies with sample sizes that ensure power, or blinded for end-point assessment,to support the evidence on pharmacological and non-pharmacological treatments of Pain after amputation. Consequently, our study was designed to arrive at clear conclusions about treatment efficacy and to give stronger recommendations for clinical practice.
- Conditions
- Pain, Complications
- Being tested
- Local analgesic, Intravenous analgesic, ropivacaine, flurbiprofen
- Keywords
- Local analgesia system, Ropivacaine, Analgesic efficacy after operation, Postoperative
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local analgesicProcedure or surgery
Patient will be performed under combined lumbar plexus and sciatic nerve block with 0.33% ropivacaine.At the end of surgery,two catheters are left in the wound.One is intraarticular and the other is on the surface of articular cavity.And then a pump elastomeric infusion pump will be connected with the catheters, which runs 5mL every hours.
Intravenous analgesicProcedure or surgery
People in this group will also receive an anesthesia of combined lumbar plexus and sciatic nerve block with 0.33% ropivacaine.An intravenous electronic analgesia pump infusion of flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg will will provide postoperative pain management.The patients will received a 2 mL/h continuous basal infusion and 1 mL boluses with a lockout time of 30 min after a 5 mL Loading dose at the end of the surgery.
ropivacaineDrug
0.2% ropivacaine
flurbiprofenDrug
flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg
| Study group | Role | What they receive |
|---|---|---|
| Local analgesic | Experimental | This group uses local analgesia infusion pump of 0.2% ropivacaine 360ml through periarticular infiltration for postoperative analgesia. Receives: Procedure: Local analgesic; Drug: ropivacaine |
| Intravenous analgesic | Active comparator | This group is treated with intravenous electronic analgesia pump infusion of flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg. Receives: Procedure: Intravenous analgesic; Drug: flurbiprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
Up to 72 hours after operation,postoperative pain visual analogue scale(VAS) scores are used to evaluate the level of pain.
Measured: 72 hours postoperation
Secondary outcomes (2)
Phantom pain
Investigators asked the patient wether there is phantom pain at three months after surgery
Measured: three months postoperation
complication
Investigators document the incidence of nausea,vomiting,headache,urinary retention and et al
Measured: 72 hours postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military Command
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, bo xu, Guangzhou General Hospital of Guangzhou Military Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114463
- Sponsor's protocol ID
- Phantom limb pain
- Status last verified
- Mar 2015
- First submitted
- 8 Apr 2014
- Last updated
- 12 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Kinds of Postoperative Analgesia After Amputation:a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02114463
- Acronym / sponsor ID
- Phantom limb pain
- Conditions
- Pain, Complications
- Keywords
- Local analgesia system, Ropivacaine, Analgesic efficacy after operation, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military CommandUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 15 Apr 2014 (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.
Pain after amputation is a significant problem among amputees. Phantom limb pain may appear in up to 85% of patients and is usually resistant to a wide variety of treatments.It is believed that regional anesthesia, by preventing the establishment of central sensitization, may play a role in reducing the incidence of acute and chronic pain. Therefore the investigators will compare two methods of postoperative analgesic after after amputation by their efficiency and complication.
Detailed description
Peripheral nerve transection results in an afferent nociceptive barrage that initiates spinal cord hyperexcitability with expansion of the receptive fields of dorsal horn neurons that respond to the nearest intact afferents. These neuroplastic changes are believed to be responsible for the development of postsurgical chronic pain syndromes, including phantom limb and stump pain.At present, there are no randomized studies with sample sizes that ensure power, or blinded for end-point assessment,to support the evidence on pharmacological and non-pharmacological treatments of Pain after amputation. Consequently, our study was designed to arrive at clear conclusions about treatment efficacy and to give stronger recommendations for clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local analgesic | Experimental | Procedure: Local analgesic, Drug: ropivacaineThis group uses local analgesia infusion pump of 0.2% ropivacaine 360ml through periarticular infiltration for postoperative analgesia. |
| Intravenous analgesic | Active comparator | Procedure: Intravenous analgesic, Drug: flurbiprofenThis group is treated with intravenous electronic analgesia pump infusion of flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of American Association of anesthetists（ASA）Grade 1 or 2
- Aged between 18 and 65 years
- Undergoing elective total knee replacement
Key exclusion criteria (5 listed)
- Mental illness can not match
- Nerve block, epidural anesthesia contraindicated
- People who have Slow-type arrhythmias
- History of chronic headaches and long-term use of analgesic drugs
- People who were postoperative consciousness, language or hearing impaired
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 |
|---|---|---|
| Local analgesicPatient will be performed under combined lumbar plexus and sciatic nerve block with 0.33% ropivacaine.At the end of surgery,two catheters are left in the wound.One is intraarticular and the other is on the surface of articular cavity.And then a pump elastomeric infusion pump will be connected with the catheters, which runs 5mL every hours. | Procedure or surgery | Local analgesic |
| Intravenous analgesicPeople in this group will also receive an anesthesia of combined lumbar plexus and sciatic nerve block with 0.33% ropivacaine.An intravenous electronic analgesia pump infusion of flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg will will provide postoperative pain management.The patients will received a 2 mL/h continuous basal infusion and 1 mL boluses with a lockout time of 30 min after a 5 mL Loading dose at the end of the surgery. | Procedure or surgery | Intravenous analgesic |
| ropivacaine0.2% ropivacaine | Drug | Local analgesic |
| flurbiprofenflurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg | Drug | Intravenous analgesic |
Primary outcome
pain
Time frame: 72 hours postoperation
Up to 72 hours after operation,postoperative pain visual analogue scale(VAS) scores are used to evaluate the level of pain.
2 secondary outcomes
Phantom pain
Time frame: three months postoperation
complication
Time frame: 72 hours postoperation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2015.
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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.
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 Local analgesic, Intravenous analgesic and ropivacaine in people with Pain and Complications, run by Guangzhou General Hospital of Guangzhou Military Command 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Mar 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact bo xu, associate chief physician (88653387 ext. 020, xubo333@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain (time frame: 72 hours postoperation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2015.