Fascia Iliaca BlockPhase 4NCT07643792
Fascia Iliaca Block Using Liposomal Bupivacaine for Analgesia After Hip Surgery
A Phase 4 study testing Liposomal bupivacaine (LB) and Plain bupivacaine in people with Fascia Iliaca Block and Liposomal Bupivacaine, run by Peking University First Hospital at 1 site in China.
Trial summary
Patients after hip surgery often suffer from severe pain. Inadequate analgesia increases the risk of postoperative delirium, myocardial injury, and other complications. Peripheral nerve block is an important component of multimodal analgesia, but conventional local anesthetics (such as plain bupivacaine) provide only… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fascia Iliaca Block, Liposomal Bupivacaine, Postoperative Pain
- What is being tested?
- Liposomal bupivacaine (LB) and Plain bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- Aug 2026to Aug 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years.
- Scheduled to undergo hip replacement surgery.
- Agree to receive regional nerve block and postoperative patient-controlled intravenous analgesia (PCIA).
Who cannot join
- Inability to communicate due to visual, auditory, language, or other reasons before surgery.
- Chronic opioid dependence and long-term use of various types of analgesics (for more than 3 months).
- Severe coagulation abnormalities (International Normalized Ratio > 1.7, activated partial thromboplastin time exceeding the normal value by more than 4 seconds, platelet count < 80 × 10⁹/L), trauma or infection at the intended puncture site, or severe low back pain.
- Preoperative severe renal insufficiency (serum creatinine > 442 μmol/L or requiring renal replacement therapy), hepatic insufficiency (Child-Pugh class C), or ASA physical status > IV.
- Known allergy to local anesthetics.
- Any other condition that the investigator or attending physician deems unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Dong-Xin Wang, MD, PhD, 010-83572784, wangdongxin@hotmail.com
About this study
Official title: Fascia Iliaca Block Using Liposomal Bupivacaine for Analgesia After Hip Surgery: a Randomized Trial
Patients after hip surgery often suffer from severe pain. Inadequate analgesia increases the risk of postoperative delirium, myocardial injury, and other complications. Peripheral nerve block is an important component of multimodal analgesia, but conventional local anesthetics (such as plain bupivacaine) provide only approximately 12 hours of analgesic duration, which is far from covering the most painful 72 hours after surgery. Liposomal bupivacaine has a slow-release property, prolonging the analgesic duration up to 72 hours after a single injection. However, its clinical advantages in hip fracture surgery remain controversial. The investigators suppose that, compared with plain bupivacaine alone, preoperative supra-inguinal fascia iliaca block using liposomal bupivacaine combined with plain bupivacaine can further improve analgesia, decrease opioid consumption, and improve postoperative recovery quality within 72 hours in older patients after hip fracture surgery.
Read the detailed description
Hip joint diseases are among the major disorders that impair patients' motor function and quality of life. With the acceleration of population aging and the advancement of hip reconstruction techniques, the number of patients undergoing hip arthroplasty has continued to increase. Hip arthroplasty primarily includes hemiarthroplasty and total hip arthroplasty (THA), with indications covering a variety of diseases and injuries, including osteonecrosis of the femoral head, hip osteoarthritis, ankylosing spondylitis, developmental dysplasia of the hip, and other conditions that lead to structural destruction and functional impairment of the hip joint. Hip arthroplasty can effectively relieve pain, improve joint function, and enhance patients' quality of life, and has become an important treatment modality for end-stage hip joint diseases.
Optimizing analgesia through multimodal strategies can enhance postoperative recovery and shorten hospital stays. Peripheral nerve blocks (PNB), particularly ultrasound-guided femoral nerve block or supra-inguinal fascia iliaca compartment block (FICB), have been shown to reduce pain and opioid consumption after hip surgery. A recent prospective cohort study indicated that better perioperative pain control with PNB is associated with lower opioid needs and shorter hospitalization.
Conventional local anesthetics like ropivacaine or bupivacaine provide analgesia for about 12 hours, which is insufficient for the entire perioperative period. Liposomal bupivacaine, an extended-release formulation, can provide analgesia for up to 72 hours. Some studies have demonstrated benefits of liposomal bupivacaine for nerve blocks in thoracic and hip surgeries, including improved recovery quality, reduced opioid use, and lower pain scores at 24-72 hours. However, evidence remains controversial; several meta-analyses suggest that while statistical differences exist, clinical relevance may be limited.
Inadequate pain control negatively affects postoperative outcomes and is associated with delirium, myocardial injury, and pulmonary complications-especially in vulnerable older patients with reduced physiological reserve and multiple comorbidities. Therefore, this randomized controlled trial aims to investigate whether preoperative FICB using liposomal bupivacaine combined with plain bupivacaine can provide superior perioperative analgesia compared with plain bupivacaine alone in older (≥55 years) patients undergoing hip fracture surgery.
- Being tested
- Liposomal bupivacaine (LB), Plain bupivacaine
- Keywords
- Fascia Iliaca Block, Liposomal Bupivacaine, Postoperative Pain, Hip surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaine (LB)Drug
A single preoperative ultrasound-guided supra-inguinal fascia iliaca block will be perfomed using a mixture of 10 mL of 0.5% plain bupivacaine plus 20 mL of liposomal bupivacaine (266 mg), total volume 30 mL. The injection will be performed after negative aspiration and under real-time ultrasound visualization to ensure proper spread between the fascia iliaca and the iliacus muscle. The block will be performed in the preoperative holding area.
Plain bupivacaineDrug
A single preoperative ultrasound-guided supra-inguinal fascia iliaca block will be performed using 30 mL of 0.5% plain bupivacaine (150 mg). The injection will be performed after negative aspiration and under real-time ultrasound visualization to ensure proper spread between the fascia iliaca and the iliacus muscle. The block will be performed in the preoperative holding area.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal bupivacaine group | Experimental | Participants in this arm will receive a single preoperative ultrasound-guided supra-inguinal fascia iliaca block. The mixture used for nerve block will consist of 10 mL of 0.5% plain bupivacaine plus 20 mL of liposomal bupivacaine (266 mg), for a total volume of 30 mL. The mixture will be injected after negative aspiration and under real-time ultrasound visualization to confirm correct needle tip position between the fascia iliaca and the iliacus muscle. The block will be performed in the preoperative holding area. Receives: Drug: Liposomal bupivacaine (LB) |
| Plain bupivacaine group | Active comparator | Participants in this arm will receive a single preoperative ultrasound-guided supra-inguinal fascia iliaca block. The mixture used for nerve block will consist of 30 mL of 0.5% plain bupivacaine (total 150 mg). The mixture will be injected after negative aspiration and under real-time ultrasound visualization to confirm correct needle tip position between the fascia iliaca and the iliacus muscle. The block will be performed in the preoperative holding area. Receives: Drug: Plain bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under curve of pain intensity within 72 hours after surgery
Pain intentsity will be assessed with the numeric rating scale (NRS; an 11-point where 0=no pain and 10=the worst pain) at 2, 6, 12 hours and then very 12 hours, until 72 hours after surgey. The area under curve of pain intensity will be calculated using the trapezoidal rule.
Measured: Up to 72 hours after the surgery
Secondary outcomes (2)
Cumulative opioid consumption within 72 hours after surgery
Cumulative opioid consumption will be calculated as intravenous morphine equivalent dosage.
Measured: Up to 72 hours after the surgery
Incidence of cardiovascular events within 7 days after surgery
Cardiovascular events includes myocardial injury, non-fatal cardiac arrest, and all-cause death.
Measured: Up to 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study startAug 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Fascia Iliaca BlockStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Xin Wang, Peking University First Hospital
- Investigators
- Dong-Xin Wang, MD, PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643792
- Sponsor's protocol ID
- 2026R0311
- Status last verified
- Jun 2026
- First submitted
- 7 Jun 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Austin PC. Balance diagnostics for comparing the distribution of baseline covariates between treatment groups in propensity-score matched samples. Stat Med. 2009 Nov 10;28(25):3083-107. doi: 10.1002/sim.3697.
PubMed 19757444Senn S. Analysis of serial measurements in medical research. BMJ. 1990 Mar 10;300(6725):680. doi: 10.1136/bmj.300.6725.680. No abstract available.
PubMed 2322712Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542Myles PS, Hunt JO, Nightingale CE, Fletcher H, Beh T, Tanil D, Nagy A, Rubinstein A, Ponsford JL. Development and psychometric testing of a quality of recovery score after general anesthesia and surgery in adults. Anesth Analg. 1999 Jan;88(1):83-90. doi: 10.1097/00000539-199901000-00016.
PubMed 9895071Vandepitte C, Kuroda M, Witvrouw R, Anne L, Bellemans J, Corten K, Vanelderen P, Mesotten D, Leunen I, Heylen M, Van Boxstael S, Golebiewski M, Van de Velde M, Knezevic NN, Hadzic A. Addition of Liposome Bupivacaine to Bupivacaine HCl Versus Bupivacaine HCl Alone for Interscalene Brachial Plexus Block in Patients Having Major Shoulder Surgery. Reg Anesth Pain Med. 2017 May/Jun;42(3):334-341. doi: 10.1097/AAP.0000000000000560.
PubMed 28157791O'Reilly N, Desmet M, Kearns R. Fascia iliaca compartment block. BJA Educ. 2019 Jun;19(6):191-197. doi: 10.1016/j.bjae.2019.03.001. Epub 2019 Apr 24. No abstract available.
PubMed 33456890Banco D, Dodson JA, Berger JS, Smilowitz NR. Perioperative cardiovascular outcomes among older adults undergoing in-hospital noncardiac surgery. J Am Geriatr Soc. 2021 Oct;69(10):2821-2830. doi: 10.1111/jgs.17320. Epub 2021 Jun 27.
PubMed 34176124Shea RA, Brooks JA, Dayhoff NE, Keck J. Pain intensity and postoperative pulmonary complications among the elderly after abdominal surgery. Heart Lung. 2002 Nov-Dec;31(6):440-9. doi: 10.1067/mhl.2002.129449.
PubMed 12434145White N, Bazo-Alvarez JC, Koopmans M, West E, Sampson EL. Understanding the association between pain and delirium in older hospital inpatients: systematic review and meta-analysis. Age Ageing. 2024 Apr 1;53(4):afae073. doi: 10.1093/ageing/afae073.
PubMed 38610062Ma JH, Liu YF, Hong H, Li CJ, Cui F, Mu DL, Wang DX. Effect of acute pain on the association between preoperative cognitive impairment and postoperative delirium: a secondary analysis of three trials. Br J Anaesth. 2023 Feb;130(2):e272-e280. doi: 10.1016/j.bja.2022.06.033. Epub 2022 Aug 3.
PubMed 35933172Dinges HC, Wiesmann T, Otremba B, Wulf H, Eberhart LH, Schubert AK. The analgesic efficacy of liposomal bupivacaine compared with bupivacaine hydrochloride for the prevention of postoperative pain: a systematic review and meta-analysis with trial sequential analysis. Reg Anesth Pain Med. 2021 Jun;46(6):490-498. doi: 10.1136/rapm-2020-102427. Epub 2021 Apr 9.
PubMed 33837139Hussain N, Brull R, Sheehy B, Essandoh MK, Stahl DL, Weaver TE, Abdallah FW. Perineural Liposomal Bupivacaine Is Not Superior to Nonliposomal Bupivacaine for Peripheral Nerve Block Analgesia. Anesthesiology. 2021 Feb 1;134(2):147-164. doi: 10.1097/ALN.0000000000003651.
PubMed 33372953Ilfeld BM, Eisenach JC, Gabriel RA. Clinical Effectiveness of Liposomal Bupivacaine Administered by Infiltration or Peripheral Nerve Block to Treat Postoperative Pain. Anesthesiology. 2021 Feb 1;134(2):283-344. doi: 10.1097/ALN.0000000000003630.
PubMed 33372949Purcell RL, Brooks DI, Steelman TJ, Christensen DL, Dickens JF, Kent ML, McCabe MP, Anderson TD. Fascia Iliaca Blockade With the Addition of Liposomal Bupivacaine Versus Plain Bupivacaine for Perioperative Pain Management During Hip Arthroscopy: A Double-Blinded Prospective Randomized Control Trial. Arthroscopy. 2019 Sep;35(9):2608-2616. doi: 10.1016/j.arthro.2019.03.056. Epub 2019 Aug 8.
PubMed 31402223Chan TCW, Wong JSH, Wang F, Fang CX, Yung CS, Chan MTH, Chan WSH, Wong SSC. Addition of Liposomal Bupivacaine to Standard Bupivacaine versus Standard Bupivacaine Alone in the Supraclavicular Brachial Plexus Block: A Randomized Controlled Trial. Anesthesiology. 2024 Oct 1;141(4):732-744. doi: 10.1097/ALN.0000000000005035.
PubMed 38696340
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fascia Iliaca Block Using Liposomal Bupivacaine for Analgesia After Hip Surgery: a Randomized Trial
- ClinicalTrials.gov ID
- NCT07643792
- Acronym / sponsor ID
- 2026R0311
- Keywords
- Fascia Iliaca Block, Liposomal Bupivacaine, Postoperative Pain, Hip surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 12 Jun 2026 (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.
Patients after hip surgery often suffer from severe pain. Inadequate analgesia increases the risk of postoperative delirium, myocardial injury, and other complications. Peripheral nerve block is an important component of multimodal analgesia, but conventional local anesthetics (such as plain bupivacaine) provide only approximately 12 hours of analgesic duration, which is far from covering the most painful 72 hours after surgery. Liposomal bupivacaine has a slow-release property, prolonging the analgesic duration up to 72 hours after a single injection. However, its clinical advantages in hip fracture surgery remain controversial. The investigators suppose that, compared with plain bupivacaine alone, preoperative supra-inguinal fascia iliaca block using liposomal bupivacaine combined with plain bupivacaine can further improve analgesia, decrease opioid consumption, and improve postoperative recovery quality within 72 hours in older patients after hip fracture surgery.
Detailed description
Hip joint diseases are among the major disorders that impair patients' motor function and quality of life. With the acceleration of population aging and the advancement of hip reconstruction techniques, the number of patients undergoing hip arthroplasty has continued to increase. Hip arthroplasty primarily includes hemiarthroplasty and total hip arthroplasty (THA), with indications covering a variety of diseases and injuries, including osteonecrosis of the femoral head, hip osteoarthritis, ankylosing spondylitis, developmental dysplasia of the hip, and other conditions that lead to structural destruction and functional impairment of the hip joint. Hip arthroplasty can effectively relieve pain, improve joint function, and enhance patients' quality of life, and has become an important treatment modality for end-stage hip joint diseases.
Optimizing analgesia through multimodal strategies can enhance postoperative recovery and shorten hospital stays. Peripheral nerve blocks (PNB), particularly ultrasound-guided femoral nerve block or supra-inguinal fascia iliaca compartment block (FICB), have been shown to reduce pain and opioid consumption after hip surgery. A recent prospective cohort study indicated that better perioperative pain control with PNB is associated with lower opioid needs and shorter hospitalization.
Conventional local anesthetics like ropivacaine or bupivacaine provide analgesia for about 12 hours, which is insufficient for the entire perioperative period. Liposomal bupivacaine, an extended-release formulation, can provide analgesia for up to 72 hours. Some studies have demonstrated benefits of liposomal bupivacaine for nerve blocks in thoracic and hip surgeries, including improved recovery quality, reduced opioid use, and lower pain scores at 24-72 hours. However, evidence remains controversial; several meta-analyses suggest that while statistical differences exist, clinical relevance may be limited.
Inadequate pain control negatively affects postoperative outcomes and is associated with delirium, myocardial injury, and pulmonary complications-especially in vulnerable older patients with reduced physiological reserve and multiple comorbidities. Therefore, this randomized controlled trial aims to investigate whether preoperative FICB using liposomal bupivacaine combined with plain bupivacaine can provide superior perioperative analgesia compared with plain bupivacaine alone in older (≥55 years) patients undergoing hip fracture surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal bupivacaine group | Experimental | Drug: Liposomal bupivacaine (LB)Participants in this arm will receive a single preoperative ultrasound-guided supra-inguinal fascia iliaca block. The mixture used for nerve block will consist of 10 mL of 0.5% plain bupivacaine plus 20 mL of liposomal bupivacaine (266 mg), for a total volume of 30 mL. The mixture will be injected after negative aspiration and under real-time ultrasound visualization to confirm correct needle tip position between the fascia iliaca and the iliacus muscle. The block will be performed in the preoperative holding area. |
| Plain bupivacaine group | Active comparator | Drug: Plain bupivacaineParticipants in this arm will receive a single preoperative ultrasound-guided supra-inguinal fascia iliaca block. The mixture used for nerve block will consist of 30 mL of 0.5% plain bupivacaine (total 150 mg). The mixture will be injected after negative aspiration and under real-time ultrasound visualization to confirm correct needle tip position between the fascia iliaca and the iliacus muscle. The block will be performed in the preoperative holding area. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged ≥ 18 years.
- Scheduled to undergo hip replacement surgery.
- Agree to receive regional nerve block and postoperative patient-controlled intravenous analgesia (PCIA).
Key exclusion criteria (6 listed)
- Inability to communicate due to visual, auditory, language, or other reasons before surgery.
- Chronic opioid dependence and long-term use of various types of analgesics (for more than 3 months).
- Severe coagulation abnormalities (International Normalized Ratio > 1.7, activated partial thromboplastin time exceeding the normal value by more than 4 seconds, platelet count < 80 × 10⁹/L), trauma or infection at the intended puncture site, or severe low back pain.
- Preoperative severe renal insufficiency (serum creatinine > 442 μmol/L or requiring renal replacement therapy), hepatic insufficiency (Child-Pugh class C), or ASA physical status > IV.
- Known allergy to local anesthetics.
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 |
|---|---|---|
| Liposomal bupivacaine (LB)A single preoperative ultrasound-guided supra-inguinal fascia iliaca block will be perfomed using a mixture of 10 mL of 0.5% plain bupivacaine plus 20 mL of liposomal bupivacaine (266 mg), total volume 30 mL. The injection will be performed after negative aspiration and under real-time ultrasound visualization to ensure proper spread between the fascia iliaca and the iliacus muscle. The block will be performed in the preoperative holding area. | Drug | Liposomal bupivacaine group |
| Plain bupivacaineA single preoperative ultrasound-guided supra-inguinal fascia iliaca block will be performed using 30 mL of 0.5% plain bupivacaine (150 mg). The injection will be performed after negative aspiration and under real-time ultrasound visualization to ensure proper spread between the fascia iliaca and the iliacus muscle. The block will be performed in the preoperative holding area. | Drug | Plain bupivacaine group |
Primary outcome
The area under curve of pain intensity within 72 hours after surgery
Time frame: Up to 72 hours after the surgery
Pain intentsity will be assessed with the numeric rating scale (NRS; an 11-point where 0=no pain and 10=the worst pain) at 2, 6, 12 hours and then very 12 hours, until 72 hours after surgey. The area under curve of pain intensity will be calculated using the trapezoidal rule.
2 secondary outcomes
Cumulative opioid consumption within 72 hours after surgery
Time frame: Up to 72 hours after the surgery
Incidence of cardiovascular events within 7 days after surgery
Time frame: Up to 7 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Background: PubMed 19757444Austin PC. Balance diagnostics for comparing the distribution of baseline covariates between treatment groups in propensity-score matched samples. Stat Med. 2009 Nov 10;28(25):3083-107. doi: 10.1002/sim.3697.
- Background: PubMed 2322712Senn S. Analysis of serial measurements in medical research. BMJ. 1990 Mar 10;300(6725):680. doi: 10.1136/bmj.300.6725.680. No abstract available.
- Background: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Background: PubMed 9895071Myles PS, Hunt JO, Nightingale CE, Fletcher H, Beh T, Tanil D, Nagy A, Rubinstein A, Ponsford JL. Development and psychometric testing of a quality of recovery score after general anesthesia and surgery in adults. Anesth Analg. 1999 Jan;88(1):83-90. doi: 10.1097/00000539-199901000-00016.
- Background: PubMed 28157791Vandepitte C, Kuroda M, Witvrouw R, Anne L, Bellemans J, Corten K, Vanelderen P, Mesotten D, Leunen I, Heylen M, Van Boxstael S, Golebiewski M, Van de Velde M, Knezevic NN, Hadzic A. Addition of Liposome Bupivacaine to Bupivacaine HCl Versus Bupivacaine HCl Alone for Interscalene Brachial Plexus Block in Patients Having Major Shoulder Surgery. Reg Anesth Pain Med. 2017 May/Jun;42(3):334-341. doi: 10.1097/AAP.0000000000000560.
- Background: PubMed 33456890O'Reilly N, Desmet M, Kearns R. Fascia iliaca compartment block. BJA Educ. 2019 Jun;19(6):191-197. doi: 10.1016/j.bjae.2019.03.001. Epub 2019 Apr 24. No abstract available.
- Background: PubMed 34176124Banco D, Dodson JA, Berger JS, Smilowitz NR. Perioperative cardiovascular outcomes among older adults undergoing in-hospital noncardiac surgery. J Am Geriatr Soc. 2021 Oct;69(10):2821-2830. doi: 10.1111/jgs.17320. Epub 2021 Jun 27.
- Background: PubMed 12434145Shea RA, Brooks JA, Dayhoff NE, Keck J. Pain intensity and postoperative pulmonary complications among the elderly after abdominal surgery. Heart Lung. 2002 Nov-Dec;31(6):440-9. doi: 10.1067/mhl.2002.129449.
- Background: PubMed 38610062White N, Bazo-Alvarez JC, Koopmans M, West E, Sampson EL. Understanding the association between pain and delirium in older hospital inpatients: systematic review and meta-analysis. Age Ageing. 2024 Apr 1;53(4):afae073. doi: 10.1093/ageing/afae073.
- Background: PubMed 35933172Ma JH, Liu YF, Hong H, Li CJ, Cui F, Mu DL, Wang DX. Effect of acute pain on the association between preoperative cognitive impairment and postoperative delirium: a secondary analysis of three trials. Br J Anaesth. 2023 Feb;130(2):e272-e280. doi: 10.1016/j.bja.2022.06.033. Epub 2022 Aug 3.
- Background: PubMed 33837139Dinges HC, Wiesmann T, Otremba B, Wulf H, Eberhart LH, Schubert AK. The analgesic efficacy of liposomal bupivacaine compared with bupivacaine hydrochloride for the prevention of postoperative pain: a systematic review and meta-analysis with trial sequential analysis. Reg Anesth Pain Med. 2021 Jun;46(6):490-498. doi: 10.1136/rapm-2020-102427. Epub 2021 Apr 9.
- Background: PubMed 33372953Hussain N, Brull R, Sheehy B, Essandoh MK, Stahl DL, Weaver TE, Abdallah FW. Perineural Liposomal Bupivacaine Is Not Superior to Nonliposomal Bupivacaine for Peripheral Nerve Block Analgesia. Anesthesiology. 2021 Feb 1;134(2):147-164. doi: 10.1097/ALN.0000000000003651.
- 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.
Dong-Xin Wang, MD, PhD principal investigator
Peking University First 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 Liposomal bupivacaine (LB) and Plain bupivacaine in people with Fascia Iliaca Block and Liposomal Bupivacaine, run by Peking University First 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 6 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: opening soon, as of the sponsor's last update on 11 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dong-Xin Wang, MD, PhD (010-83572784, wangdongxin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The area under curve of pain intensity within 72 hours after surgery (time frame: Up to 72 hours after the surgery). 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 NCT07643792, which also lists 37 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 11 Aug 2026.