Radius FracturesPhase 4ADRIBNCT02630290
Addition of Dexmedetomidine to Ropivacaine-induced Supraclavicular Block (ADRIB Trial)
A Phase 4 study testing Ropivacaine and Ropivacaine + Dexmedetomidine in people with Radius Fractures and Ulna Fractures, run by Guangzhou First People's Hospital at 1 site in China.
Trial summary
Dexmedetomidine, an alpha 2-adrenoreceptor agonist, has been found to exerts an excellent influences on the filed of perineural block. It could shorten the onset time and prolong the duration of the nerve block and improved postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Radius Fractures, Ulna Fractures, Hand Injuries
- What is being tested?
- Ropivacaine and Ropivacaine + Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Jun 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Surgery: elective forearm and hand surgery under ultrasound-guided supraclavicular brachial plexus block
- American Society of Anesthesiologist(ASA) physical status of Ⅰ to III
- Age between 18 to 60 years old
Who cannot join
- Having an ongoing another clinical trials
- Taking antihypertensive drugs such as methyldopa, clonidine and other α2 receptor agonist
- Peripheral neuropathy
- Cerebrovascular disease
- Psychiatric disease
- Coagulopathies
Show all 11Show fewer
- Pregnant women
- Liver and kidney dysfunction
- Heart failure
- Known allergy or hypersensitive reaction to dexmedetomidine or anesthetic
- Patient refusal
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou First Municipal People's Hospital
Guangzhou, Guangdong, 020
About this study
Official title: Addition of Dexmedetomidine to Ropivacaine-induced Supraclavicular Plexus Block, a Randomized Controlled Study
Dexmedetomidine, an alpha 2-adrenoreceptor agonist, has been found to exerts an excellent influences on the filed of perineural block. It could shorten the onset time and prolong the duration of the nerve block and improved postoperative pain. However, Dexmedetomidine-induced bradycardia or hypotension has recently attracted considerable attention because of potentially grave consequences, including sinus arrest and refractory cardiogenic shock. A low dose may help minimize cardiovascular risks associated with dexmedetomidine. However, few studies have addressed the clinical effects of low-dose dexmedetomidine as an perineural adjuvant. The present study was designed to test the hypothesis that low-dose dexmedetomidine added to ropivacaine would safely enhance the duration of analgesia without adverse effects when compared with ropivacaine alone. Investigators will conduct a single-center, prospective, randomized, triple-blind, controlled trial in patients undergoing elective forearm and hand surgery under ultrasound-guided supraclavicular brachial plexus block using either ropivacaine or ropivacaine plus low-dose dexmedetomidine. The primary outcome is self-reported duration of analgesia . Secondary outcomes include onset time and duration of motor and sensory block, total postoperative analgesics, and safety assessment (adverse effects and postoperative abnormal sensation).
Read the detailed description
Dexmedetomidine, an alpha 2-adrenoreceptor agonist, has been found to exerts an excellent influences on the filed of perineural block. It could shorten the onset time and prolong the duration of the nerve block and improved postoperative pain. However, Dexmedetomidine-induced bradycardia or hypotension has recently attracted considerable attention because of potentially grave consequences, including sinus arrest and refractory cardiogenic shock. Although meta-analysis showed that perineural dexmedetomidine as a local anaesthetic adjuvant for neuraxial and peripheral nerve blocks produced reversible bradycardia in only 7% of brachial plexus block patients and no effect on the incidence of hypotension, various clinical studies reported a significant decrease in heart rate. A low dose may help minimize cardiovascular risks associated with dexmedetomidine. However, few studies have addressed the clinical effects of low-dose dexmedetomidine as an perineural adjuvant. The present study was designed to test the hypothesis that low-dose dexmedetomidine, which till today has not been reported in the literature, added to ropivacaine for brachial plexus block would safely enhance the duration of analgesia without adverse effects when compared with ropivacaine alone. Investigators will conduct a single-center, prospective, randomized, triple-blind, controlled trial in patients undergoing elective forearm and hand surgery under ultrasound-guided supraclavicular brachial plexus block using either 20 mL of 0.5% ropivacaine or 0.5% ropivacaine plus 30 microg dexmedetomidine. The primary outcome is self-reported duration of analgesia . Secondary outcomes include onset time and duration of motor and sensory block, total postoperative analgesics, and safety assessment (adverse effects including cardiovascular inhibitions and postoperative abnormal sensation). Data will be collected and analyzed in a blinded fashion.
- Being tested
- Ropivacaine, Ropivacaine + Dexmedetomidine
- Keywords
- Brachial plexus block, Dexmedetomidine, Ropivacaine, ultrasound-guided nerve block, supraclavicular brachial plexus block
- Medical subject headings
- Radius Fractures, Ulna Fractures, Hand Injuries, Wrist Injuries, Forearm Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called placebo
Ultrasound-guided supraclavicular brachial plexus block with 0.5% ropivacaine
Ropivacaine + DexmedetomidineDrug
Also called experimental
Ultrasound-guided supraclavicular brachial plexus block with 0.5% ropivacaine plus low-dose (30 microg) dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine | Placebo comparator | After a careful aspiration, 1 to 2 mL of normal saline is injected for a distribution in and around the brachial plexus. Additional needle tip repositioning and injections may be needed when the distribution is not attained. Then the study drug (0.5% ropivacaine in a total volume of 20 mL) will be injected with additional fine adjustment of the block needle under continuous ultrasound monitoring. Receives: Drug: Ropivacaine |
| Ropivacaine + Dexmedetomidine | Experimental | After skin infiltration with 1-2 mL of lidocaine 2%, a 21-gauge 90-mm spinal needle will be inserted into the brachial plexus sheath using in-plane technique. After a careful aspiration, 1 to 2 mL of normal saline is injected for a distribution in and around the brachial plexus. Additional needle repositioning and injections may be needed when the distribution is not attained. Then the study drug (0.5% ropivacaine plus 30 microg dexmedetomidine in a total volume of 20 mL) will be injected with additional fine adjustment of the block needle under realtime ultrasound monitoring. Receives: Drug: Ropivacaine + Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of analgesia
Postoperative pain using visual analog scale (VAS, 0-100, 0 = no pain, 100 = maximum imaginable pain) will be assessed. Duration of analgesia is defined by time between administration of block and the postoperative pain >3.
Measured: up to 24 hours postoperatively
Secondary outcomes (16)
Blood pressure (BP)
Noninvasive arterial BP is measured at the non-operated arm. episode of hypotension (30% decrease in mean BP in relation to baseline values) and hypertension (30% increase in mean BP in relation to baseline values) will be recorded.
Measured: up to 24 hours postoperatively
Heart rate (HR):
HR, bradycardia (HR < 50 beats/min), and tachycardia (HR > 100 beats/min) will be recorded at the same time as BP recording.
Measured: up to 24 hours postoperatively
Peripheral oxygen saturation (SpO2)
SpO2 and hypoxemia (SpO2 <90%) will be recorded at the same time as BP recording.
Measured: up to 24 hours postoperatively
Sensory block of median nerve
is defined by pinprick sensation using a 3-point scale (0-2, 0 = normal sensation, 1 = decreased pain sensation to pinprick, 2 = loss of pain sensation to pinprick) in the median nerve locations.
Measured: up to 30 minutes after administration of block
Sensory block of ulnar nerve
Sensory block of ulnar nerve is defined by pinprick sensation using a 3-point scale (0-2, 0 = normal sensation, 1 = decreased pain sensation to pinprick, 2 = loss of pain sensation to pinprick) in the ulnar nerve locations.
Measured: up to 30 minutes after administration of block
Sensory block of radial nerve
Sensory block of radial nerve is defined by pinprick sensation using a 3-point scale (0-2, 0 = normal sensation, 1 = decreased pain sensation to pinprick, 2 = loss of pain sensation to pinprick) in the radial nerve locations.
Measured: up to 30 minutes after administration of block
Sensory block of musculocutaneous nerve
Sensory block of musculocutaneous nerve is defined by pinprick sensation using a 3-point scale (0-2, 0 = normal sensation, 1 = decreased pain sensation to pinprick, 2 = loss of pain sensation to pinprick) in the musculocutaneous nerve locations.
Measured: up to 30 minutes after administration of block
Motor block of median nerve
Motor block of median nerve is defined by thumb and fifth finger pinch.
Measured: up to 30 minutes after administration of block
Motor block of ulnar nerve
Motor block of ulnar nerve is defined thumb and second finger pinch.
Measured: up to 30 minutes after administration of block
Motor block of radial nerve
Motor block of radial nerve is defined by finger abduction.
Measured: up to 30 minutes after administration of block
Motor block of musculocutaneous nerve
Motor block of musculocutaneous nerve is defined by flexion of the elbow.
Measured: up to 30 minutes after administration of block
Duration of motor block
Duration of motor block is defined as the time interval between the administration of the block and the recovery of complete motor function of the hand and forearm assessed.
Measured: up to 24 hours postoperatively
Success rate of nerve block
A successful block is defined as surgery without patient discomfort and the need for supplementation of local infiltration or general anesthesia
Measured: 30 minutes after administration of block
Postoperative analgesic requirement
IV tramadol 50mg will be administered when postoperative pain >3, and be titrated up by 50 mg increments as needed for pain every 4 to 6 hours, with the maximum total dose of 250mg.
Measured: up to 24 hours postoperatively
Postoperative nausea and vomiting (PONV)
The incidence of PONV will be recorded using a 4-point objective score (1 = no PONV;2 = mild nausea, no vomiting; 3 = excessive nausea or vomiting;4 = vomiting ≥2 times).
Measured: up to 24 hours postoperatively
Abnormal sensation of brachial plexus
Patient's self-reported abnormal sensation of the hand and forearm.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Radius FracturesStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou First People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangcai Ruan, MD, PhD, Vice-Director in Dept Anesth & Pain, Guangzhou First People's Hospital
- Investigators
- Xiangcai Ruan, MD, PhD, Principal investigator, Guangzhou First People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630290
- Sponsor's protocol ID
- GZZD-2015008
- Acronym
- ADRIB
- Status last verified
- Aug 2016
- First submitted
- 3 Dec 2015
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Wu HH, Wang HT, Jin JJ, Cui GB, Zhou KC, Chen Y, Chen GZ, Dong YL, Wang W. Does dexmedetomidine as a neuraxial adjuvant facilitate better anesthesia and analgesia? A systematic review and meta-analysis. PLoS One. 2014 Mar 26;9(3):e93114. doi: 10.1371/journal.pone.0093114. eCollection 2014.
PubMed 24671181Marhofer D, Kettner SC, Marhofer P, Pils S, Weber M, Zeitlinger M. Dexmedetomidine as an adjuvant to ropivacaine prolongs peripheral nerve block: a volunteer study. Br J Anaesth. 2013 Mar;110(3):438-42. doi: 10.1093/bja/aes400. Epub 2012 Nov 15.
PubMed 23161360Abdallah FW, Brull R. Facilitatory effects of perineural dexmedetomidine on neuraxial and peripheral nerve block: a systematic review and meta-analysis. Br J Anaesth. 2013 Jun;110(6):915-25. doi: 10.1093/bja/aet066. Epub 2013 Apr 15.
PubMed 23587874Esmaoglu A, Yegenoglu F, Akin A, Turk CY. Dexmedetomidine added to levobupivacaine prolongs axillary brachial plexus block. Anesth Analg. 2010 Dec;111(6):1548-51. doi: 10.1213/ANE.0b013e3181fa3095. Epub 2010 Oct 1.
PubMed 20889939Liu W, Guo J, Zheng J, Zheng B, Ruan X; Addition of Dexmedetomidine to Ropivacaine-Induced supraclavicular Block (ADRIB) investigator. Low-dose dexmedetomidine as a perineural adjuvant for postoperative analgesia: a randomized controlled trial. BMC Anesthesiol. 2022 Aug 5;22(1):249. doi: 10.1186/s12871-022-01791-6.
PubMed 35931989
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of Dexmedetomidine to Ropivacaine-induced Supraclavicular Plexus Block, a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02630290
- Acronym / sponsor ID
- ADRIB / GZZD-2015008
- Keywords
- Brachial plexus block, Dexmedetomidine, Ropivacaine, ultrasound-guided nerve block, supraclavicular brachial plexus block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Guangzhou First People's HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 15 Dec 2015 (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.
Dexmedetomidine, an alpha 2-adrenoreceptor agonist, has been found to exerts an excellent influences on the filed of perineural block. It could shorten the onset time and prolong the duration of the nerve block and improved postoperative pain. However, Dexmedetomidine-induced bradycardia or hypotension has recently attracted considerable attention because of potentially grave consequences, including sinus arrest and refractory cardiogenic shock. A low dose may help minimize cardiovascular risks associated with dexmedetomidine. However, few studies have addressed the clinical effects of low-dose dexmedetomidine as an perineural adjuvant. The present study was designed to test the hypothesis that low-dose dexmedetomidine added to ropivacaine would safely enhance the duration of analgesia without adverse effects when compared with ropivacaine alone. Investigators will conduct a single-center, prospective, randomized, triple-blind, controlled trial in patients undergoing elective forearm and hand surgery under ultrasound-guided supraclavicular brachial plexus block using either ropivacaine or ropivacaine plus low-dose dexmedetomidine. The primary outcome is self-reported duration of analgesia . Secondary outcomes include onset time and duration of motor and sensory block, total postoperative analgesics, and safety assessment (adverse effects and postoperative abnormal sensation).
Detailed description
Dexmedetomidine, an alpha 2-adrenoreceptor agonist, has been found to exerts an excellent influences on the filed of perineural block. It could shorten the onset time and prolong the duration of the nerve block and improved postoperative pain. However, Dexmedetomidine-induced bradycardia or hypotension has recently attracted considerable attention because of potentially grave consequences, including sinus arrest and refractory cardiogenic shock. Although meta-analysis showed that perineural dexmedetomidine as a local anaesthetic adjuvant for neuraxial and peripheral nerve blocks produced reversible bradycardia in only 7% of brachial plexus block patients and no effect on the incidence of hypotension, various clinical studies reported a significant decrease in heart rate. A low dose may help minimize cardiovascular risks associated with dexmedetomidine. However, few studies have addressed the clinical effects of low-dose dexmedetomidine as an perineural adjuvant. The present study was designed to test the hypothesis that low-dose dexmedetomidine, which till today has not been reported in the literature, added to ropivacaine for brachial plexus block would safely enhance the duration of analgesia without adverse effects when compared with ropivacaine alone. Investigators will conduct a single-center, prospective, randomized, triple-blind, controlled trial in patients undergoing elective forearm and hand surgery under ultrasound-guided supraclavicular brachial plexus block using either 20 mL of 0.5% ropivacaine or 0.5% ropivacaine plus 30 microg dexmedetomidine. The primary outcome is self-reported duration of analgesia . Secondary outcomes include onset time and duration of motor and sensory block, total postoperative analgesics, and safety assessment (adverse effects including cardiovascular inhibitions and postoperative abnormal sensation). Data will be collected and analyzed in a blinded fashion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine | Placebo comparator | Drug: RopivacaineAfter a careful aspiration, 1 to 2 mL of normal saline is injected for a distribution in and around the brachial plexus. Additional needle tip repositioning and injections may be needed when the distribution is not attained. Then the study drug (0.5% ropivacaine in a total volume of 20 mL) will be injected with additional fine adjustment of the block needle under continuous ultrasound monitoring. |
| Ropivacaine + Dexmedetomidine | Experimental | Drug: Ropivacaine + DexmedetomidineAfter skin infiltration with 1-2 mL of lidocaine 2%, a 21-gauge 90-mm spinal needle will be inserted into the brachial plexus sheath using in-plane technique. After a careful aspiration, 1 to 2 mL of normal saline is injected for a distribution in and around the brachial plexus. Additional needle repositioning and injections may be needed when the distribution is not attained. Then the study drug (0.5% ropivacaine plus 30 microg dexmedetomidine in a total volume of 20 mL) will be injected with additional fine adjustment of the block needle under realtime ultrasound monitoring. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Surgery: elective forearm and hand surgery under ultrasound-guided supraclavicular brachial plexus block
- American Society of Anesthesiologist(ASA) physical status of Ⅰ to III
- Age between 18 to 60 years old
Key exclusion criteria (11 listed)
- Having an ongoing another clinical trials
- Taking antihypertensive drugs such as methyldopa, clonidine and other α2 receptor agonist
- Peripheral neuropathy
- Cerebrovascular disease
- Psychiatric disease
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 |
|---|---|---|
| RopivacaineAlso: placeboUltrasound-guided supraclavicular brachial plexus block with 0.5% ropivacaine | Drug | Ropivacaine |
| Ropivacaine + DexmedetomidineAlso: experimentalUltrasound-guided supraclavicular brachial plexus block with 0.5% ropivacaine plus low-dose (30 microg) dexmedetomidine | Drug | Ropivacaine + Dexmedetomidine |
Primary outcome
Duration of analgesia
Time frame: up to 24 hours postoperatively
Postoperative pain using visual analog scale (VAS, 0-100, 0 = no pain, 100 = maximum imaginable pain) will be assessed. Duration of analgesia is defined by time between administration of block and the postoperative pain >3.
16 secondary outcomes
Blood pressure (BP)
Time frame: up to 24 hours postoperatively
Heart rate (HR):
Time frame: up to 24 hours postoperatively
Peripheral oxygen saturation (SpO2)
Time frame: up to 24 hours postoperatively
Sensory block of median nerve
Time frame: up to 30 minutes after administration of block
Sensory block of ulnar nerve
Time frame: up to 30 minutes after administration of block
Sensory block of radial nerve
Time frame: up to 30 minutes after administration of block
Sensory block of musculocutaneous nerve
Time frame: up to 30 minutes after administration of block
Motor block of median nerve
Time frame: up to 30 minutes after administration of block
Motor block of ulnar nerve
Time frame: up to 30 minutes after administration of block
Motor block of radial nerve
Time frame: up to 30 minutes after administration of block
Motor block of musculocutaneous nerve
Time frame: up to 30 minutes after administration of block
Duration of motor block
Time frame: up to 24 hours postoperatively
Success rate of nerve block
Time frame: 30 minutes after administration of block
Postoperative analgesic requirement
Time frame: up to 24 hours postoperatively
Postoperative nausea and vomiting (PONV)
Time frame: up to 24 hours postoperatively
Abnormal sensation of brachial plexus
Time frame: Day 1
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 12 Aug 2016.
- Results publication: PubMed 24671181Wu HH, Wang HT, Jin JJ, Cui GB, Zhou KC, Chen Y, Chen GZ, Dong YL, Wang W. Does dexmedetomidine as a neuraxial adjuvant facilitate better anesthesia and analgesia? A systematic review and meta-analysis. PLoS One. 2014 Mar 26;9(3):e93114. doi: 10.1371/journal.pone.0093114. eCollection 2014.
- Results publication: PubMed 23161360Marhofer D, Kettner SC, Marhofer P, Pils S, Weber M, Zeitlinger M. Dexmedetomidine as an adjuvant to ropivacaine prolongs peripheral nerve block: a volunteer study. Br J Anaesth. 2013 Mar;110(3):438-42. doi: 10.1093/bja/aes400. Epub 2012 Nov 15.
- Results publication: PubMed 23587874Abdallah FW, Brull R. Facilitatory effects of perineural dexmedetomidine on neuraxial and peripheral nerve block: a systematic review and meta-analysis. Br J Anaesth. 2013 Jun;110(6):915-25. doi: 10.1093/bja/aet066. Epub 2013 Apr 15.
- Results publication: PubMed 20889939Esmaoglu A, Yegenoglu F, Akin A, Turk CY. Dexmedetomidine added to levobupivacaine prolongs axillary brachial plexus block. Anesth Analg. 2010 Dec;111(6):1548-51. doi: 10.1213/ANE.0b013e3181fa3095. Epub 2010 Oct 1.
- Derived from this study: PubMed 35931989Liu W, Guo J, Zheng J, Zheng B, Ruan X; Addition of Dexmedetomidine to Ropivacaine-Induced supraclavicular Block (ADRIB) investigator. Low-dose dexmedetomidine as a perineural adjuvant for postoperative analgesia: a randomized controlled trial. BMC Anesthesiol. 2022 Aug 5;22(1):249. doi: 10.1186/s12871-022-01791-6.
- Individual participant dataSharing planned: Undecided
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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.
Xiangcai Ruan, MD, PhD principal investigator
Guangzhou First People's Hospital
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 Ropivacaine and Ropivacaine + Dexmedetomidine in people with Radius Fractures and Ulna Fractures, run by Guangzhou First People's Hospital 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 11 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 12 Aug 2016. 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. Some participants in this study may receive a placebo. 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?
Duration of analgesia (time frame: up to 24 hours postoperatively). 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 NCT02630290, which also lists 5 linked publications.
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 Aug 2016; AzTrials last refreshed its copy on 8 Nov 2026.