Liver SurgeryNCT04668391
Anterior Quadratus Lumborum Block at the Lateral Supra-arcuate Ligament for Analgesia After Open Liver Surgery
A study testing Ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament and Thoracic epidural analgesia in people with Liver Surgery, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
This is a prospective, randomized, controlled, noninferiority trial for evaluating the efficacy of ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament versus thoracic epidural analgesia after open liver surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Surgery
- What is being tested?
- Ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament and Thoracic epidural analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 17 Dec 2020to 2 Jul 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18 years
- ASA I-III
- Open liver surgery
Who cannot join
- Contraindication to nerve block or epidural puncture
- Chronic use of opioids or NSAIDs
- Refused to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Anterior Quadratus Lumborum Block at the Lateral Supra-arcuate Ligament Versus Thoracic Epidural Analgesia After Open Liver Surgery: A Prospective, Randomized, Controlled, Noninferiority Trial
This is a prospective, randomized, controlled, noninferiority trial for evaluating the efficacy of ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament versus thoracic epidural analgesia after open liver surgery.
- Conditions
- Liver Surgery
- Being tested
- Ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament, Thoracic epidural analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligamentProcedure or surgery
Bilateral single-injection 20 ml 0.56% ropivacaine. Intravenous analgesia was started postoperatively and consisted of 1ug/ml sufentanil，2 ml/h with a 5-minute lockout period, a limited 12 ml/h dose.
Thoracic epidural analgesiaProcedure or surgery
A thoracic epidural at the level of T7-10. Epidural infusion was started postoperatively and consisted of sufentanil (0.6ug/mL) and ropivacaine（0.2%） at 3ml/h.
| Study group | Role | What they receive |
|---|---|---|
| Quadratus lumborum block | Experimental | Ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament. Receives: Procedure: Ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament |
| Thoracic epidural analgesia | Active comparator | Thoracic epidural analgesia at the level of T7-10. Receives: Procedure: Thoracic epidural analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS (numeric rating scale) score for coughing pain
Postoperative pain was assessed by NRS score with a range of 0 to 10 (0=no pain, 10=the worst possible pain)
Measured: at 24 hours after surgery
Secondary outcomes (14)
NRS score for rest and coughing pain
Postoperative pain at rest and during coughing was assessed by NRS score with a range of 0 to 10 (0=no pain, 10=the worst possible pain)
Measured: at 1, 6, 24, 48, 72 hours after surgery
consumption of opioid converted to IV morphine equivalents
opioids given postoperatively converted to IV morphine equivalents
Measured: during 24 hours after surgery
Numbers of additional analgesics
Additional rescue analgesics were used when pain relief was inadequate (NRS >3). The choice of rescue analgesic was oxydone 5-10mg.
Measured: during 72 hours after surgery
The incidence of postoperative hypotension
Adverse reactions related to analgesia
Measured: during 72 hours after surgery
The incidence of nausea and vomiting
Adverse reactions related to analgesia
Measured: during 72 hours after surgery
The incidence of pruritus
Adverse reactions related to analgesia
Measured: during 72 hours after surgery
The incidence of respiratory depression
Adverse reactions related to analgesia
Measured: during 72 hours after surgery
Time to ambulation in days
Postoperative ambulation time
Measured: through study completion, an average of 2-3 days
Time to eat in days
Time to start eating after surgery
Measured: through study completion, an average of 2-3 days
Time to flatus in hours
Time to flatus after surgery
Measured: through study completion, an average of 40-50 hours
Time to defecation in hours
Time to defecation after surgery
Measured: through study completion, an average of 60-70 hours
Time to urethral catheter removal in hours
Time tourethral catheter removal after surgery
Measured: through study completion, an average of 60-70 hours
Postoperative hospital stay in days
The time from operation to discharge
Measured: through study completion, an average of 7-8 days
Clavien-Dindo classification (grade I, II, III, IV) for postoperative complication
Postoperative Clavien-Dindo complication classification
Measured: One month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start17 Dec 2020
- Primary completion2 Jun 2021
- Study completion2 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver SurgeryStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huifang Jiang, Zhejiang Cancer Hospital
- Investigators
- Huifang Jiang, M.D., Principal investigator, Zhejiang Caner Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668391
- Sponsor's protocol ID
- IRB-2020-350
- Status last verified
- Jun 2022
- First submitted
- 13 Dec 2020
- Last updated
- 6 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Postoperative numeric rating scale (NRS) pain score at rest and during coughing at 1, 6, 24, 48 and 72 hours after surgery.
Publications
Li H, Ma D, Liu Y, Wang Y. A transverse approach for ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament. Anaesthesia. 2020 Oct;75(10):1400-1401. doi: 10.1111/anae.15058. Epub 2020 Jun 24. No abstract available.
PubMed 32578192Gu B, Zhou H, Lian Y, Zhou Y, He S, Xie K, Jiang H. Ultrasound-Guided Anterior Quadratus Lumborum Block at Lateral Supra-Arcuate Ligament vs Thoracic Epidural Analgesia after Open Liver Surgery: A Randomized, Controlled, Noninferiority Trial. J Am Coll Surg. 2022 Dec 1;235(6):871-878. doi: 10.1097/XCS.0000000000000354. Epub 2022 Nov 15.
PubMed 36102582
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Anterior Quadratus Lumborum Block at the Lateral Supra-arcuate Ligament Versus Thoracic Epidural Analgesia After Open Liver Surgery: A Prospective, Randomized, Controlled, Noninferiority Trial
- ClinicalTrials.gov ID
- NCT04668391
- Acronym / sponsor ID
- IRB-2020-350
- Conditions
- Liver Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 2 Jul 2021 (actual)
- First posted
- 16 Dec 2020 (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.
This is a prospective, randomized, controlled, noninferiority trial for evaluating the efficacy of ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament versus thoracic epidural analgesia after open liver surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadratus lumborum block | Experimental | Procedure: Ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligamentUltrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament. |
| Thoracic epidural analgesia | Active comparator | Procedure: Thoracic epidural analgesiaThoracic epidural analgesia at the level of T7-10. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age≥18 years
- ASA I-III
- Open liver surgery
Key exclusion criteria (3 listed)
- Contraindication to nerve block or epidural puncture
- Chronic use of opioids or NSAIDs
- Refused to participate in the study
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 |
|---|---|---|
| Ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligamentBilateral single-injection 20 ml 0.56% ropivacaine. Intravenous analgesia was started postoperatively and consisted of 1ug/ml sufentanil，2 ml/h with a 5-minute lockout period, a limited 12 ml/h dose. | Procedure or surgery | Quadratus lumborum block |
| Thoracic epidural analgesiaA thoracic epidural at the level of T7-10. Epidural infusion was started postoperatively and consisted of sufentanil (0.6ug/mL) and ropivacaine（0.2%） at 3ml/h. | Procedure or surgery | Thoracic epidural analgesia |
Primary outcome
NRS (numeric rating scale) score for coughing pain
Time frame: at 24 hours after surgery
Postoperative pain was assessed by NRS score with a range of 0 to 10 (0=no pain, 10=the worst possible pain)
14 secondary outcomes
NRS score for rest and coughing pain
Time frame: at 1, 6, 24, 48, 72 hours after surgery
consumption of opioid converted to IV morphine equivalents
Time frame: during 24 hours after surgery
Numbers of additional analgesics
Time frame: during 72 hours after surgery
The incidence of postoperative hypotension
Time frame: during 72 hours after surgery
The incidence of nausea and vomiting
Time frame: during 72 hours after surgery
The incidence of pruritus
Time frame: during 72 hours after surgery
The incidence of respiratory depression
Time frame: during 72 hours after surgery
Time to ambulation in days
Time frame: through study completion, an average of 2-3 days
Time to eat in days
Time frame: through study completion, an average of 2-3 days
Time to flatus in hours
Time frame: through study completion, an average of 40-50 hours
Time to defecation in hours
Time frame: through study completion, an average of 60-70 hours
Time to urethral catheter removal in hours
Time frame: through study completion, an average of 60-70 hours
Postoperative hospital stay in days
Time frame: through study completion, an average of 7-8 days
Clavien-Dindo classification (grade I, II, III, IV) for postoperative complication
Time frame: One month after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Background: PubMed 32578192Li H, Ma D, Liu Y, Wang Y. A transverse approach for ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament. Anaesthesia. 2020 Oct;75(10):1400-1401. doi: 10.1111/anae.15058. Epub 2020 Jun 24. No abstract available.
- Derived from this study: PubMed 36102582Gu B, Zhou H, Lian Y, Zhou Y, He S, Xie K, Jiang H. Ultrasound-Guided Anterior Quadratus Lumborum Block at Lateral Supra-Arcuate Ligament vs Thoracic Epidural Analgesia after Open Liver Surgery: A Randomized, Controlled, Noninferiority Trial. J Am Coll Surg. 2022 Dec 1;235(6):871-878. doi: 10.1097/XCS.0000000000000354. Epub 2022 Nov 15.
- Individual participant dataSharing planned: Yes. Postoperative numeric rating scale (NRS) pain score at rest and during coughing at 1, 6, 24, 48 and 72 hours after surgery.
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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.
Huifang Jiang, M.D. principal investigator
Zhejiang Caner Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament and Thoracic epidural analgesia in people with Liver Surgery, run by Zhejiang Cancer 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 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS (numeric rating scale) score for coughing pain (time frame: at 24 hours after 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 NCT04668391, which also lists 2 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 6 Jul 2022.