Postoperative PainNCT06550869
Application of Anterior Quadratus Lumborum Block at the Lateral Supra-arcuate Ligament Under Laparoscopic Direct Vision in Laparoscopic Renal Surgery
A study testing Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct vision and Local infiltration anesthesia in people with Postoperative Pain and Analgesia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Evaluation of the effectiveness of Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct vision compared to local infiltration anesthesia for postoperative analgesia after laparoscopic renal surgery in patients.A randomized controlled trial involving 66 patients undergoing… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain, Analgesia, Quadratus Lumborum Block
- What is being tested?
- Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct vision and Local infiltration anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 14 Aug 2024to Aug 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 80 years old;
- American Society of Anesthesiologists (ASA) physical status classification: I to III;
- Undergoing laparoscopic nephrectomy or partial nephrectomy (including robotic-assisted laparoscopic nephrectomy and partial nephrectomy).
Who cannot join
- Recent use of anticoagulant medications or abnormal coagulation function;
- Local infection at the puncture site or the presence of tumors, severe deformities, or systemic infection;
- Severe renal failure (serum creatinine > 442 μmol/L or requiring renal replacement therapy) or liver dysfunction (Child-Pugh Class C);
- Known allergy to local anesthetics or a family history of local anesthetic allergy;
- Preoperative cognitive impairment or inability to assess pain;
- Alcoholism, drug abuse, chronic opioid dependence, or the use of analgesics or psychotropic medications for more than 3 months;
Show all 9Show fewer
- History of central and/or peripheral nervous system disorders or myasthenia gravis;
- Planned admission to the ICU;
- Surgical cancellation or patient refusal, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second affiliated Hospital School of Medicine,Zhejiang University
Hangzhou, Zhejiang
Lina Yu, doctor, +8613958033387, zryulina@zju.edu.cn
About this study
Official title: Application of Anterior Quadratus Lumborum Block at the Lateral Supra-arcuate Ligament Under Laparoscopic Direct Vision in Laparoscopic Renal Surgery：A Randomized, Controlled Trial
Evaluation of the effectiveness of Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct vision compared to local infiltration anesthesia for postoperative analgesia after laparoscopic renal surgery in patients.A randomized controlled trial involving 66 patients undergoing laparoscopic renal surgery will assign them randomly to an experimental group or a control group.The patients in experimental group will receive Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct vision.The patients in control group will receive local infiltration anesthesia.The primary outcome measure is the cumulative consumption of intravenous morphine equivalents at postoperative 24 hours.The secondary outcomes include the cumulative consumption of intravenous morphine equivalents at postoperative 2, 4, 6, 12 and 48 hours, Numeric Rating Scale(NRS) score at rest and during activity (coughing) at postoperative 2, 6, 24 and 48 hours, Global Comfort Questionnaire(GCQ) Comfort Status Scale Score, Quality of Recovery-15(QoR-15) Postoperative Recovery Scale Score, time of the first press on the Patient-Controlled Analgesia pump, nausea, vomiting, skin itching, drowsiness, or other adverse reactions, regional anesthesia-related complications such as local anesthetic toxicity and length of postoperative hospital stay after surgery.
Read the detailed description
The patients were 1:1 randomly assigned into groups by a clinical researcher not involved in the clinical procedures or data collection. The random numbers were generated by R studio 4.1.0 (R studio, Boston, MA, USA) software in a 1:1 ratio, with a block size of 8 for each group. The generated random numbers were sealed in opaque envelopes with sequential numbers. On the day of surgery, the envelope was opened by the protocol executor according to the recruitment order before the induction of general anesthesia.Data collection is in the charge of special personnel, and Case Report Form shall be filled in timely after data collection. At the same time, the electronic database was edited by Excel, and the electronic database was entered timely after filling in the paper Case Report form.
- Being tested
- Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct vision, Local infiltration anesthesia
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct visionProcedure or surgery
The urologists find the inner arcuate ligament. The scalp needle is inserted from the midpoint of the lower edge of the inner or outer arcuate ligament towards the head to the dorsal side of the diaphragm. After withdrawing without blood, air, or cerebrospinal fluid, 2 ml of normal saline is first administered to observe the fluid spreading towards the head Then, 20 ml of 0.375% ropivacaine hydrochloride injection is administered.
Local infiltration anesthesiaProcedure or surgery
The urologists give local infiltration anesthesia with 20 ml of 0.375% ropivacaine hydrochloride injection.
| Study group | Role | What they receive |
|---|---|---|
| QLB-LSAL | Experimental | The patient received Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct vision. Receives: Procedure: Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct vision |
| LA | Active comparator | The patient received local infiltration anesthesia. Receives: Procedure: Local infiltration anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
intravenous morphine equivalents
The cumulative consumption of intravenous morphine equivalents
Measured: Postoperative 24 hours
Secondary outcomes (8)
intravenous morphine equivalents
The cumulative consumption of intravenous morphine equivalents
Measured: Postoperative 2, 4, 6, 12 and 48 hours
Numeric Rating Scale
Numeric Rating Scale（NRS） score at rest and during activity (coughing),the pain score is from 0-10,0 is no pain,10 is the most.
Measured: postoperative 2, 6, 24 and 48 hours
Global Comfort Questionnaire
Global Comfort Questionnaire（GCQ） Kolcaba Scale Score,it includes 28 questions,1 is not agree with,4 is very agree with,the total score is 114.
Measured: Preoperative and postoperative 24 hours
Quality of Recovery-15
Quality of Recovery-15（QoR-15） Postoperative Recovery Scale Score,it includes 15 questions,0 is the worst,10 is the best,total score is 150.
Measured: Postoperative 24 hours
Time of the first press on Patient-Controlled Analgesia
Time of the first press on the Patient-Controlled Intravenous Analgesia pump
Measured: Postoperative 48 hours
adverse reactions
Nausea, vomiting, skin itching, drowsiness, and other adverse reactions
Measured: Postoperative 72 hours
Regional anesthesia-related complications
Regional anesthesia-related complications such as local anesthetic toxicity
Measured: Postoperative 72 hours
Length of hospital stay
Length of postoperative hospital stay
Measured: Postoperative 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start14 Aug 2024
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lina Yu, doctor, Study director, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550869
- Sponsor's protocol ID
- 2024-0806
- Status last verified
- Jul 2024
- First submitted
- 7 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Anterior Quadratus Lumborum Block at the Lateral Supra-arcuate Ligament Under Laparoscopic Direct Vision in Laparoscopic Renal Surgery：A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT06550869
- Acronym / sponsor ID
- 2024-0806
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 13 Aug 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.
Evaluation of the effectiveness of Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct vision compared to local infiltration anesthesia for postoperative analgesia after laparoscopic renal surgery in patients.A randomized controlled trial involving 66 patients undergoing laparoscopic renal surgery will assign them randomly to an experimental group or a control group.The patients in experimental group will receive Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct vision.The patients in control group will receive local infiltration anesthesia.The primary outcome measure is the cumulative consumption of intravenous morphine equivalents at postoperative 24 hours.The secondary outcomes include the cumulative consumption of intravenous morphine equivalents at postoperative 2, 4, 6, 12 and 48 hours, Numeric Rating Scale(NRS) score at rest and during activity (coughing) at postoperative 2, 6, 24 and 48 hours, Global Comfort Questionnaire(GCQ) Comfort Status Scale Score, Quality of Recovery-15(QoR-15) Postoperative Recovery Scale Score, time of the first press on the Patient-Controlled Analgesia pump, nausea, vomiting, skin itching, drowsiness, or other adverse reactions, regional anesthesia-related complications such as local anesthetic toxicity and length of postoperative hospital stay after surgery.
Detailed description
The patients were 1:1 randomly assigned into groups by a clinical researcher not involved in the clinical procedures or data collection. The random numbers were generated by R studio 4.1.0 (R studio, Boston, MA, USA) software in a 1:1 ratio, with a block size of 8 for each group. The generated random numbers were sealed in opaque envelopes with sequential numbers. On the day of surgery, the envelope was opened by the protocol executor according to the recruitment order before the induction of general anesthesia.Data collection is in the charge of special personnel, and Case Report Form shall be filled in timely after data collection. At the same time, the electronic database was edited by Excel, and the electronic database was entered timely after filling in the paper Case Report form.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QLB-LSAL | Experimental | Procedure: Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct visionThe patient received Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct vision. |
| LA | Active comparator | Procedure: Local infiltration anesthesiaThe patient received local infiltration anesthesia. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 18 to 80 years old;
- American Society of Anesthesiologists (ASA) physical status classification: I to III;
- Undergoing laparoscopic nephrectomy or partial nephrectomy (including robotic-assisted laparoscopic nephrectomy and partial nephrectomy).
Key exclusion criteria (9 listed)
- Recent use of anticoagulant medications or abnormal coagulation function;
- Local infection at the puncture site or the presence of tumors, severe deformities, or systemic infection;
- Severe renal failure (serum creatinine > 442 μmol/L or requiring renal replacement therapy) or liver dysfunction (Child-Pugh Class C);
- Known allergy to local anesthetics or a family history of local anesthetic allergy;
- Preoperative cognitive impairment or inability to assess pain;
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 |
|---|---|---|
| Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct visionThe urologists find the inner arcuate ligament. The scalp needle is inserted from the midpoint of the lower edge of the inner or outer arcuate ligament towards the head to the dorsal side of the diaphragm. After withdrawing without blood, air, or cerebrospinal fluid, 2 ml of normal saline is first administered to observe the fluid spreading towards the head Then, 20 ml of 0.375% ropivacaine hydrochloride injection is administered. | Procedure or surgery | QLB-LSAL |
| Local infiltration anesthesiaThe urologists give local infiltration anesthesia with 20 ml of 0.375% ropivacaine hydrochloride injection. | Procedure or surgery | LA |
Primary outcome
intravenous morphine equivalents
Time frame: Postoperative 24 hours
The cumulative consumption of intravenous morphine equivalents
8 secondary outcomes
intravenous morphine equivalents
Time frame: Postoperative 2, 4, 6, 12 and 48 hours
Numeric Rating Scale
Time frame: postoperative 2, 6, 24 and 48 hours
Global Comfort Questionnaire
Time frame: Preoperative and postoperative 24 hours
Quality of Recovery-15
Time frame: Postoperative 24 hours
Time of the first press on Patient-Controlled Analgesia
Time frame: Postoperative 48 hours
adverse reactions
Time frame: Postoperative 72 hours
Regional anesthesia-related complications
Time frame: Postoperative 72 hours
Length of hospital stay
Time frame: Postoperative 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- 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.
Lina Yu, doctor study director
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct vision and Local infiltration anesthesia in people with Postoperative Pain and Analgesia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 9 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 20 Aug 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. 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 Lina Yu, doctor (+86 13958033387, zryulina@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intravenous morphine equivalents (time frame: Postoperative 24 hours). 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 20 Aug 2024.