Liposomal BupivacainePhase 4NCT06145165
A Analgesic Study of Adductor Canal &IPACK Block with Liposomal Bupivacaine in Knee Arthroplasty
A Phase 4 study testing Nerve block with ropivacaine and intravenous analgesia, Nerve block with liposomal bupivacaine and intravenous analgesia and Intravenous analgesia in people with Liposomal Bupivacaine and Postoperative Recovery, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
To study the effectiveness of ACB and iPACK block with liposomal bupivacaine for postoperative analgesia in patients undergoing knee arthroplasty Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Liposomal Bupivacaine, Postoperative Recovery, Unilateral Knee Arthroplasty
- What is being tested?
- Nerve block with ropivacaine and intravenous analgesia, Nerve block with liposomal bupivacaine and intravenous analgesia and Intravenous analgesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2023to 31 Dec 2024
- 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-79 years.
- Patients undergoing unilateral total knee arthroplasty or unicondylar joint replacement.
- Normal diet.
- ASA grade I~Ⅲ;
- BMI 18-30kg /m2.
- No intraspinal anesthesia contraindications.
Who cannot join
- Patients with severe neurological diseases.
- Hearing and speech impaired.
- Preoperative gastric emptying disorders, such as gastrointestinal obstruction, gastroesophageal reflux, or previous gastrointestinal surgery, etc.
- Patients with severe renal insufficiency or other severe metabolic diseases.
- Mental disorders, alcoholism or a history of drug abuse.
- The surgical time is greater than 3 hours.
- Puncture site infection, abnormal coagulation function, and local anesthetic allergy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Liu Han, MD, 18951670163, han_cold.student@sina.com
About this study
Official title: A Analgesic Study of Adductor Canal &IPACK Block with Liposomal Bupivacaine in Knee Arthroplasty ：A Randomized，Double-controlled，Parallel-controlled，Single-center Study
To study the effectiveness of ACB and iPACK block with liposomal bupivacaine for postoperative analgesia in patients undergoing knee arthroplasty
Read the detailed description
The pain after knee arthroplasty limits the patient's activities and postoperative recovery, and currently there are mainly three analgesic methods: intravenous analgesia, epidural analgesia and nerve block analgesia. There is a lack of studies on whether liposomal bupivacaine, if used for ACB and iPACK block, can achieve benefits in knee arthroplasty pain management by prolonging sensory nerve block without affecting muscle strength, improving patient prognosis, and shortening hospitalization days.
In this study, in order to better evaluate the effect of liposomal bupivacaine for ACB and iPACK biock on the prognosis of patients undergoing knee arthroplasty, not only the NRS and AUC of patients in each group will be observed, but also the postoperative QoR-15 Quality of Recovery Rating Scale, postoperative nausea, vomiting and other complications, and the number of hospitalization days will be also included as observation indicators. The completion of this study can provide a clinical basis for the selection of analgesic regimens for knee arthroplasty, and also provide strong evidence-based medical support for the relevant medical decision making of government departments.
- Being tested
- Nerve block with ropivacaine and intravenous analgesia, Nerve block with liposomal bupivacaine and intravenous analgesia, Intravenous analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve block with ropivacaine and intravenous analgesiaOther
When the MOAA/S score is 5 after the surgery,the PCIA pump equipped with sufentanil injection will be connected,if the patient's resting NRS ≥ 4 points , they should be given sufentanil 5 ug intravenously at intervals of more than 8 minutes until NRS ≤ 3.
Nerve block with liposomal bupivacaine and intravenous analgesiaCombination product
When the MOAA/S score is 5 after the surgery,the PCIA pump equipped with sufentanil injection will be connected,if the patient's resting NRS ≥ 4 points , they should be given sufentanil 5 ug intravenously at intervals of more than 8 minutes until NRS ≤ 3.
Intravenous analgesiaOther
When the MOAA/S score is 5 after the surgery,the PCIA pump equipped with sufentanil injection will be connected,if the patient's resting NRS ≥ 4 points , they should be given sufentanil 5 ug intravenously at intervals of more than 8 minutes until NRS ≤ 3.
| Study group | Role | What they receive |
|---|---|---|
| RP group:Nerve block with ropivacaine and intravenous analgesia group | Placebo comparator | The ropivacaine group will use ultrasound high-frequency line array probe for ACB and convex array probe for iPACK block before induction of general anesthesia Receives: Other: Nerve block with ropivacaine and intravenous analgesia |
| LP group ：Nerve block with liposomal bupivacaine and intravenous analgesia group | Experimental | The liposomal bupivacaine group will use ultrasound high-frequency line array probe for ACB and convex array probe for iPACK block before induction of general anesthesia Receives: Combination Product: Nerve block with liposomal bupivacaine and intravenous analgesia |
| control group：Intravenous analgesia group | Placebo comparator | General anesthesia was induced directly Receives: Other: Intravenous analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cumulative use of analgesic drugs (sufentanil,calculated in ug)up to 48 hours postoperative in each group
To study the effectiveness of ACB and iPACK block with liposomal bupivacaine for postoperative analgesia in patients undergoing knee arthroplasty.A lower dose of analgesics indicates a longer duration of block.
Measured: Up to 48 hours postoperative
Secondary outcomes (10)
NRS scores at rest and during exerciseat at 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours postoperative
The NRS typically consists of a straight line with numbers ranging from 0 to 10. Each number corresponds to a level of pain intensity:0: No pain.1 to 3: Mild pain （low intensity）. 4 to 6: Moderate pain （moderate intensity）. 7 to 10: Severe pain (high intensity) Patients are asked to choose a number that best represents their current pain level, where 0 means no pain, and 10 indicates the worst possible pain.A lower NRS score indicates a longer duration of block.
Measured: at 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours postoperative
The total number of PCIA compressions on the first day,the second day and the third day after surgery.
Fewer total PCIA compressions indicated a longer duration of block.
Measured: On the first day,the second day and the third day after surgery.
The number of effective PCIA compressions on the first day,the second day and the third day after surgery.
Fewer total effective PCIA compressions indicated a longer duration of block.
Measured: On the first day,the second day and the third day after surgery.
The number of times of remedial analgesia on the first day,the second day and the third day after surgery.
Fewer times of rescue analgesia indicated a longer duration of analgesia.
Measured: On the first day,the second day and the third day after surgery.
The cumulative use of analgesic drugs (sufentanil,calculated in ug)on the first day,the second day and the third day after surgery.
Less cumulative use of analgesics indicates a longer duration of block
Measured: On the first day,the second day and the third day after surgery.
The percentage of subjects who did not use remedial analgesics on the first day,the second day and the third day after surgery.
A greater percentage of subjects who did not use rescue analgesics indicated a longer duration of analgesic block.
Measured: On the first day,the second day and the third day after surgery.
Satisfaction score of subjects on the first day,the second day and the third day after surgery.
Rated on a 0-10 scale, with a higher score representing greater satisfaction.
Measured: On the first day,the second day and the third day after surgery.
Satisfaction score of surgeons on the first day,the second day and the third day after surgery.
Rated on a 0-10 scale, with a higher score representing greater satisfaction.
Measured: On the first day,the second day and the third day after surgery.
Both the liposomal bupivacaine group and the ropivacaine group were subjected to ACB and iPACK block. Area under the pain intensity-time curve within 72 hours after the first postoperative dose(PI-AUC72)was observed in the three groups.
A smaller PI-AUC72 indicates a longer duration of nerve block.
Measured: within 72 hours after the first postoperative initiation of drug administration
15-item Quality of Recovery Rating Scale (QoR-15): 24hours, 48hours and 72hours postoperatively
QoR-15 was used to assess five aspects of postoperative recovery quality (physical comfort, physical independence, psychological support, emotion and pain), with higher scores indicating the higher postoperative recovery quality. The lowest score is 0 points, and the highest score is 150 points.
Measured: at 24 hours, 48 hours and 72 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start10 Dec 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Liposomal BupivacaineStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liu Han, Study chair, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145165
- Sponsor's protocol ID
- KY20230829-05
- Status last verified
- Nov 2023
- First submitted
- 27 Oct 2023
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kukreja P, Feinstein J, Kalagara HK, Huntley SR, Lee SR, Naranje S, Shah A. A Summary of the Anatomy and Current Regional Anesthesia Practices for Postoperative Pain Management in Total Knee Arthroplasty. Cureus. 2018 Jun 7;10(6):e2755. doi: 10.7759/cureus.2755.
PubMed 30094112Sundarathiti P, Ruananukul N, Channum T, Kitkunasathean C, Mantay A, Thammasakulsiri J, Sodsee W. A comparison of continuous femoral nerve block (CFNB) and continuous epidural infusion (CEI) in postoperative analgesia and knee rehabilitation after total knee arthroplasty (TKA). J Med Assoc Thai. 2009 Mar;92(3):328-34.
PubMed 19301724Fedriani de Matos JJ, Atienza Carrasco FJ, Diaz Crespo J, Moreno Martin A, Tatsidis Tatsidis P, Torres Morera LM. Effectiveness and safety of continuous ultrasound-guided femoral nerve block versus epidural analgesia after total knee arthroplasty. Rev Esp Anestesiol Reanim. 2017 Feb;64(2):79-85. doi: 10.1016/j.redar.2016.05.008. Epub 2016 Jul 9. English, Spanish.
PubMed 27400891Yu YL, Cao DH, Chen B, Yang ZH, You KZ. Continuous femoral nerve block and patient-controlled intravenous postoperative analgesia on Th1/Th2 in patients undergoing total knee arthroplasty. J Biol Regul Homeost Agents. 2018 May-Jun;32(3):641-647.
PubMed 29921393Vora MU, Nicholas TA, Kassel CA, Grant SA. Adductor canal block for knee surgical procedures: review article. J Clin Anesth. 2016 Dec;35:295-303. doi: 10.1016/j.jclinane.2016.08.021. Epub 2016 Oct 11.
PubMed 27871547Mou P, Wang D, Tang XM, Zeng WN, Zeng Y, Yang J, Zhou ZK. Adductor Canal Block Combined With IPACK Block for Postoperative Analgesia and Function Recovery Following Total Knee Arthroplasty: A Prospective, Double-Blind, Randomized Controlled Study. J Arthroplasty. 2022 Feb;37(2):259-266. doi: 10.1016/j.arth.2021.10.004. Epub 2021 Oct 13.
PubMed 34653576Hasabo EA, Assar A, Mahmoud MM, Abdalrahman HA, Ibrahim EA, Hasanin MA, Emam AK, AbdelQadir YH, AbdelAzim AA, Ali AS. Adductor canal block versus femoral nerve block for pain control after total knee arthroplasty: A systematic review and Meta-analysis. Medicine (Baltimore). 2022 Aug 26;101(34):e30110. doi: 10.1097/MD.0000000000030110.
PubMed 36042669Hussain N, Brull R, Sheehy B, Dasu M, Weaver T, Abdallah FW. Does the addition of iPACK to adductor canal block in the presence or absence of periarticular local anesthetic infiltration improve analgesic and functional outcomes following total knee arthroplasty? A systematic review and meta-analysis. Reg Anesth Pain Med. 2021 Aug;46(8):713-721. doi: 10.1136/rapm-2021-102705. Epub 2021 May 14.
PubMed 33990436
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Analgesic Study of Adductor Canal &IPACK Block with Liposomal Bupivacaine in Knee Arthroplasty ：A Randomized，Double-controlled，Parallel-controlled，Single-center Study
- ClinicalTrials.gov ID
- NCT06145165
- Acronym / sponsor ID
- KY20230829-05
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 10 Dec 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Nov 2023 (actual)
- 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.
To study the effectiveness of ACB and iPACK block with liposomal bupivacaine for postoperative analgesia in patients undergoing knee arthroplasty
Detailed description
The pain after knee arthroplasty limits the patient's activities and postoperative recovery, and currently there are mainly three analgesic methods: intravenous analgesia, epidural analgesia and nerve block analgesia. There is a lack of studies on whether liposomal bupivacaine, if used for ACB and iPACK block, can achieve benefits in knee arthroplasty pain management by prolonging sensory nerve block without affecting muscle strength, improving patient prognosis, and shortening hospitalization days.
In this study, in order to better evaluate the effect of liposomal bupivacaine for ACB and iPACK biock on the prognosis of patients undergoing knee arthroplasty, not only the NRS and AUC of patients in each group will be observed, but also the postoperative QoR-15 Quality of Recovery Rating Scale, postoperative nausea, vomiting and other complications, and the number of hospitalization days will be also included as observation indicators. The completion of this study can provide a clinical basis for the selection of analgesic regimens for knee arthroplasty, and also provide strong evidence-based medical support for the relevant medical decision making of government departments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RP group:Nerve block with ropivacaine and intravenous analgesia group | Placebo comparator | Other: Nerve block with ropivacaine and intravenous analgesiaThe ropivacaine group will use ultrasound high-frequency line array probe for ACB and convex array probe for iPACK block before induction of general anesthesia |
| LP group ：Nerve block with liposomal bupivacaine and intravenous analgesia group | Experimental | Combination Product: Nerve block with liposomal bupivacaine and intravenous analgesiaThe liposomal bupivacaine group will use ultrasound high-frequency line array probe for ACB and convex array probe for iPACK block before induction of general anesthesia |
| control group：Intravenous analgesia group | Placebo comparator | Other: Intravenous analgesiaGeneral anesthesia was induced directly |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-79 years.
- Patients undergoing unilateral total knee arthroplasty or unicondylar joint replacement.
- Normal diet.
- ASA grade I~Ⅲ;
- BMI 18-30kg /m2.
Key exclusion criteria (7 listed)
- Patients with severe neurological diseases.
- Hearing and speech impaired.
- Preoperative gastric emptying disorders, such as gastrointestinal obstruction, gastroesophageal reflux, or previous gastrointestinal surgery, etc.
- Patients with severe renal insufficiency or other severe metabolic diseases.
- Mental disorders, alcoholism or a history of drug abuse.
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 |
|---|---|---|
| Nerve block with ropivacaine and intravenous analgesiaWhen the MOAA/S score is 5 after the surgery,the PCIA pump equipped with sufentanil injection will be connected,if the patient's resting NRS ≥ 4 points , they should be given sufentanil 5 ug intravenously at intervals of more than 8 minutes until NRS ≤ 3. | Other | RP group:Nerve block with ropivacaine and intravenous analgesia group |
| Nerve block with liposomal bupivacaine and intravenous analgesiaWhen the MOAA/S score is 5 after the surgery,the PCIA pump equipped with sufentanil injection will be connected,if the patient's resting NRS ≥ 4 points , they should be given sufentanil 5 ug intravenously at intervals of more than 8 minutes until NRS ≤ 3. | Combination product | LP group ：Nerve block with liposomal bupivacaine and intravenous analgesia group |
| Intravenous analgesiaWhen the MOAA/S score is 5 after the surgery,the PCIA pump equipped with sufentanil injection will be connected,if the patient's resting NRS ≥ 4 points , they should be given sufentanil 5 ug intravenously at intervals of more than 8 minutes until NRS ≤ 3. | Other | control group：Intravenous analgesia group |
Primary outcome
The cumulative use of analgesic drugs (sufentanil,calculated in ug)up to 48 hours postoperative in each group
Time frame: Up to 48 hours postoperative
To study the effectiveness of ACB and iPACK block with liposomal bupivacaine for postoperative analgesia in patients undergoing knee arthroplasty.A lower dose of analgesics indicates a longer duration of block.
10 secondary outcomes
NRS scores at rest and during exerciseat at 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours postoperative
Time frame: at 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours postoperative
The total number of PCIA compressions on the first day,the second day and the third day after surgery.
Time frame: On the first day,the second day and the third day after surgery.
The number of effective PCIA compressions on the first day,the second day and the third day after surgery.
Time frame: On the first day,the second day and the third day after surgery.
The number of times of remedial analgesia on the first day,the second day and the third day after surgery.
Time frame: On the first day,the second day and the third day after surgery.
The cumulative use of analgesic drugs (sufentanil,calculated in ug)on the first day,the second day and the third day after surgery.
Time frame: On the first day,the second day and the third day after surgery.
The percentage of subjects who did not use remedial analgesics on the first day,the second day and the third day after surgery.
Time frame: On the first day,the second day and the third day after surgery.
Satisfaction score of subjects on the first day,the second day and the third day after surgery.
Time frame: On the first day,the second day and the third day after surgery.
Satisfaction score of surgeons on the first day,the second day and the third day after surgery.
Time frame: On the first day,the second day and the third day after surgery.
Both the liposomal bupivacaine group and the ropivacaine group were subjected to ACB and iPACK block. Area under the pain intensity-time curve within 72 hours after the first postoperative dose(PI-AUC72)was observed in the three groups.
Time frame: within 72 hours after the first postoperative initiation of drug administration
15-item Quality of Recovery Rating Scale (QoR-15): 24hours, 48hours and 72hours postoperatively
Time frame: at 24 hours, 48 hours and 72 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Background: PubMed 30094112Kukreja P, Feinstein J, Kalagara HK, Huntley SR, Lee SR, Naranje S, Shah A. A Summary of the Anatomy and Current Regional Anesthesia Practices for Postoperative Pain Management in Total Knee Arthroplasty. Cureus. 2018 Jun 7;10(6):e2755. doi: 10.7759/cureus.2755.
- Background: PubMed 19301724Sundarathiti P, Ruananukul N, Channum T, Kitkunasathean C, Mantay A, Thammasakulsiri J, Sodsee W. A comparison of continuous femoral nerve block (CFNB) and continuous epidural infusion (CEI) in postoperative analgesia and knee rehabilitation after total knee arthroplasty (TKA). J Med Assoc Thai. 2009 Mar;92(3):328-34.
- Background: PubMed 27400891Fedriani de Matos JJ, Atienza Carrasco FJ, Diaz Crespo J, Moreno Martin A, Tatsidis Tatsidis P, Torres Morera LM. Effectiveness and safety of continuous ultrasound-guided femoral nerve block versus epidural analgesia after total knee arthroplasty. Rev Esp Anestesiol Reanim. 2017 Feb;64(2):79-85. doi: 10.1016/j.redar.2016.05.008. Epub 2016 Jul 9. English, Spanish.
- Background: PubMed 29921393Yu YL, Cao DH, Chen B, Yang ZH, You KZ. Continuous femoral nerve block and patient-controlled intravenous postoperative analgesia on Th1/Th2 in patients undergoing total knee arthroplasty. J Biol Regul Homeost Agents. 2018 May-Jun;32(3):641-647.
- Background: PubMed 27871547Vora MU, Nicholas TA, Kassel CA, Grant SA. Adductor canal block for knee surgical procedures: review article. J Clin Anesth. 2016 Dec;35:295-303. doi: 10.1016/j.jclinane.2016.08.021. Epub 2016 Oct 11.
- Background: PubMed 34653576Mou P, Wang D, Tang XM, Zeng WN, Zeng Y, Yang J, Zhou ZK. Adductor Canal Block Combined With IPACK Block for Postoperative Analgesia and Function Recovery Following Total Knee Arthroplasty: A Prospective, Double-Blind, Randomized Controlled Study. J Arthroplasty. 2022 Feb;37(2):259-266. doi: 10.1016/j.arth.2021.10.004. Epub 2021 Oct 13.
- Background: PubMed 36042669Hasabo EA, Assar A, Mahmoud MM, Abdalrahman HA, Ibrahim EA, Hasanin MA, Emam AK, AbdelQadir YH, AbdelAzim AA, Ali AS. Adductor canal block versus femoral nerve block for pain control after total knee arthroplasty: A systematic review and Meta-analysis. Medicine (Baltimore). 2022 Aug 26;101(34):e30110. doi: 10.1097/MD.0000000000030110.
- Background: PubMed 33990436Hussain N, Brull R, Sheehy B, Dasu M, Weaver T, Abdallah FW. Does the addition of iPACK to adductor canal block in the presence or absence of periarticular local anesthetic infiltration improve analgesic and functional outcomes following total knee arthroplasty? A systematic review and meta-analysis. Reg Anesth Pain Med. 2021 Aug;46(8):713-721. doi: 10.1136/rapm-2021-102705. Epub 2021 May 14.
- Individual participant dataSharing planned: No
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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.
Liu Han study chair
Nanjing First Hospital, 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 Nerve block with ropivacaine and intravenous analgesia, Nerve block with liposomal bupivacaine and intravenous analgesia and Intravenous analgesia in people with Liposomal Bupivacaine and Postoperative Recovery, run by Nanjing First Hospital, 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 6 inclusion and 7 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 23 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liu Han (18951670163, han_cold.student@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cumulative use of analgesic drugs (sufentanil,calculated in ug)up to 48 hours postoperative in each group (time frame: Up to 48 hours postoperative). 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 NCT06145165, which also lists 8 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 23 Sep 2024.