Pharmacological ActionNCT06288841
Efficacy and Safety of Liposomal Bupivacaine Under ERAS Concept for Postoperative Analgesia of Ultrasound-Guided QLB in Gynecologic Laparoscopic Patients: A Randomized, Single-blind, Active-Controlled Clinical Study
A study testing Ropivacaine injection and Bupivacaine liposome in people with Pharmacological Action, run by Tianjin Medical University General Hospital at 1 site in China.
Trial summary
With the development of the concept of comfortable medicine and enhanced recovery surgery (ERAS), optimizing the perioperative management of patients, reducing surgical stress, and reducing postoperative pain can effectively reduce perioperative complications and achieve the purpose of accelerating recovery. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Pharmacological Action
- What is being tested?
- Ropivacaine injection and Bupivacaine liposome
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2023to 29 Nov 2024
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Age 18-65 years; 2) ASA grade I or II; 3) Patients who are scheduled to undergo elective laparoscopic hysterectomy or laparoscopic hysterectomy and double adnexectomy; 4) BMI of 19-29 kg/m2; 5) Patients who voluntarily sign the informed consent form.
Who cannot join
- 1) Those who are known to be allergic to the drug components of this study and have allergic constitution; 2) History of allergy to general anesthetic drugs, opioids, and non-steroidal drugs; 3) Patients who need to switch to laparotomy for various reasons; 4) history of neurological disease; History of chronic pain; drug addiction and alcohol abuse; History of long-term opioid use; Opioids are given 48 hours before surgery; 5) ASA grade III or IV; 6) Coronary heart disease, bronchial asthma, severe hypertension, severe hematologic dysfunction, liver and kidney function, and obvious abnormalities in electrolytes; 7) Patients with severe gastrointestinal diseases; 8) Patients who refuse to use intravenous PCIA for analgesia; 9) Pregnant or lactating women; 10) Patients with infection in the skin of the abdominal injection area; 11) Patients with rheumatoid or inflammatory arthritis or diseases requiring chronic analgesic treatment; 12) Patients who have been treated for deep vein thrombosis, pulmonary embolism, myocardial infarction or ischemic stroke in the past 6 months; 13) Those who have poor compliance and cannot complete the test according to the research protocol; 14) Those who have participated in clinical trials of other drugs in the past 4 weeks; 15) Any circumstances that, in the opinion of the investigators, are not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Ning Luo, 13622098703, ningluo1996@163.com
About this study
With the development of the concept of comfortable medicine and enhanced recovery surgery (ERAS), optimizing the perioperative management of patients, reducing surgical stress, and reducing postoperative pain can effectively reduce perioperative complications and achieve the purpose of accelerating recovery. As an important part of ERAS, multimodal analgesia is the core concept of perioperative analgesia management. As a kind of perioperative multimodal analgesia, quadratus lumbar muscle block (QLB) is a type of local anesthetic drug injected around the quadratus lumbar muscle to reduce or eliminate abdominal wall pain and visceral pain after abdominal surgery. QLB has been used successfully for pain control after laparoscopic and open surgery, reducing perioperative opioid use and improving prognosis-related measures such as PONV and length of hospital stay. Bupivacaine liposomes use DepoFoam technology to encapsulate the drug in polycystic liposomes, which can prolong the release time of bupivacaine due to the different rupture times of different vesicles, and the postoperative analgesia can be up to 72 hours. In this project, patients who undergo elective laparoscopic uterine and double adnexectomy were selected to be injected with lipososomes of bupivacaine at different concentrations under ultrasound guidance of bilateral posterior QLB before anesthesia induction, and the effect of liposomal bupivacaine on postoperative pain was investigated by evaluating the postoperative pain and incidence of adverse events. This study will greatly promote the clinical promotion and application of bupivacaine liposome, improve the postoperative comfort and satisfaction of patients, and accelerate the postoperative recovery of patients.
- Conditions
- Pharmacological Action
- Being tested
- Ropivacaine injection, Bupivacaine liposome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine injectionDrug
Also called Quadratus lumborum block
Ultrasound-guided bilateral QLB2 was performed using Ropivacaine injection prior to anesthesia induction
Bupivacaine liposomeDrug
Also called Quadratus lumborum block
Ultrasound-guided bilateral QLB2 was performed using Bupivacaine liposome injection prior to anesthesia induction
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine injection group | Placebo comparator | Not described Receives: Drug: Ropivacaine injection |
| Bupivacaine liposomal low-dose group | Experimental | Not described Receives: Drug: Bupivacaine liposome |
| Bupivacaine liposomal medium-dose group | Experimental | Not described Receives: Drug: Bupivacaine liposome |
| Bupivacaine liposomal high-dose group | Experimental | Not described Receives: Drug: Bupivacaine liposome |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS pain score within 72 hours after surgery
After surgery (starting from the end of surgery), NRS was evaluated at 2h, 4h, 6h, 8h, 12h, 24h, 48h, and 72h
Measured: Postoperative (starting from the end of the operation) 2 hours (h), 4h, 6h, 8h, 12h, 24h, 48h, 72h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start30 Nov 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion29 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacological ActionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ning Luo, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288841
- Sponsor's protocol ID
- TJMZ2023-008
- Status last verified
- Feb 2024
- First submitted
- 25 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Liposomal Bupivacaine Under ERAS Concept for Postoperative Analgesia of Ultrasound-Guided QLB in Gynecologic Laparoscopic Patients: A Randomized, Single-blind, Active-Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06288841
- Acronym / sponsor ID
- TJMZ2023-008
- Conditions
- Pharmacological Action
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 29 Nov 2024 (estimated)
- First posted
- 1 Mar 2024 (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.
With the development of the concept of comfortable medicine and enhanced recovery surgery (ERAS), optimizing the perioperative management of patients, reducing surgical stress, and reducing postoperative pain can effectively reduce perioperative complications and achieve the purpose of accelerating recovery. As an important part of ERAS, multimodal analgesia is the core concept of perioperative analgesia management. As a kind of perioperative multimodal analgesia, quadratus lumbar muscle block (QLB) is a type of local anesthetic drug injected around the quadratus lumbar muscle to reduce or eliminate abdominal wall pain and visceral pain after abdominal surgery. QLB has been used successfully for pain control after laparoscopic and open surgery, reducing perioperative opioid use and improving prognosis-related measures such as PONV and length of hospital stay. Bupivacaine liposomes use DepoFoam technology to encapsulate the drug in polycystic liposomes, which can prolong the release time of bupivacaine due to the different rupture times of different vesicles, and the postoperative analgesia can be up to 72 hours. In this project, patients who undergo elective laparoscopic uterine and double adnexectomy were selected to be injected with lipososomes of bupivacaine at different concentrations under ultrasound guidance of bilateral posterior QLB before anesthesia induction, and the effect of liposomal bupivacaine on postoperative pain was investigated by evaluating the postoperative pain and incidence of adverse events. This study will greatly promote the clinical promotion and application of bupivacaine liposome, improve the postoperative comfort and satisfaction of patients, and accelerate the postoperative recovery of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine injection group | Placebo comparator | Drug: Ropivacaine injection |
| Bupivacaine liposomal low-dose group | Experimental | Drug: Bupivacaine liposome |
| Bupivacaine liposomal medium-dose group | Experimental | Drug: Bupivacaine liposome |
| Bupivacaine liposomal high-dose group | Experimental | Drug: Bupivacaine liposome |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Age 18-65 years; 2) ASA grade I or II; 3) Patients who are scheduled to undergo elective laparoscopic hysterectomy or laparoscopic hysterectomy and double adnexectomy; 4) BMI of 19-29 kg/m2; 5) Patients who voluntarily sign the informed consent form.
Key exclusion criteria (1 listed)
- 1) Those who are known to be allergic to the drug components of this study and have allergic constitution; 2) History of allergy to general anesthetic drugs, opioids, and non-steroidal drugs; 3) Patients who need to switch to laparotomy for various reasons; 4) history of neurological disease; History of chronic pain; drug addiction and alcohol abuse; History of long-term opioid use; Opioids are given 48 hours before surgery; 5) ASA grade III or IV; 6) Coronary heart disease, bronchial asthma, severe hypertension, severe hematologic dysfunction, liver and kidney function, and obvious abnormalities in electrolytes; 7) Patients with severe gastrointestinal diseases; 8) Patients who refuse to use intravenous PCIA for analgesia; 9) Pregnant or lactating women; 10) Patients with infection in the skin of the abdominal injection area; 11) Patients with rheumatoid or inflammatory arthritis or diseases requiring chronic analgesic treatment; 12) Patients who have been treated for deep vein thrombosis, pulmonary embolism, myocardial infarction or ischemic stroke in the past 6 months; 13) Those who have poor compliance and cannot complete the test according to the research protocol; 14) Those who have participated in clinical trials of other drugs in the past 4 weeks; 15) Any circumstances that, in the opinion of the investigators, are not suitable for inclusion.
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 |
|---|---|---|
| Ropivacaine injectionAlso: Quadratus lumborum blockUltrasound-guided bilateral QLB2 was performed using Ropivacaine injection prior to anesthesia induction | Drug | Ropivacaine injection group |
| Bupivacaine liposomeAlso: Quadratus lumborum blockUltrasound-guided bilateral QLB2 was performed using Bupivacaine liposome injection prior to anesthesia induction | Drug | Bupivacaine liposomal high-dose group, Bupivacaine liposomal low-dose group, Bupivacaine liposomal medium-dose group |
Primary outcome
NRS pain score within 72 hours after surgery
Time frame: Postoperative (starting from the end of the operation) 2 hours (h), 4h, 6h, 8h, 12h, 24h, 48h, 72h
After surgery (starting from the end of surgery), NRS was evaluated at 2h, 4h, 6h, 8h, 12h, 24h, 48h, and 72h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
Related trials for Pharmacological Action
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in Europe (PLATINUM EU)
Neuromuscular Agents, Peripheral Nervous System Agents
RecruitingObservational study
Natural History of Depression, Bipolar Disorder and Suicide Risk
Behavioral Symptoms, Suicide
Recruiting
Efficacy and Safety of Ultrasound-Guided Pharmacopuncture as an Adjunctive Therapy in Inpatients With Post-Traffic Accident Tension-Type Headache
Pharmacologic Action
RecruitingPhase 3
A Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD)
Alpha 1 Antitrypsin Deficiency
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 study testing Ropivacaine injection and Bupivacaine liposome in people with Pharmacological Action, run by Tianjin Medical University General 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 1 inclusion and 1 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 1 Mar 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.
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 Ning Luo (13622098703, ningluo1996@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS pain score within 72 hours after surgery (time frame: Postoperative (starting from the end of the operation) 2 hours (h), 4h, 6h, 8h, 12h, 24h, 48h, 72h). 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 1 Mar 2024.