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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quadratus lumborum block | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | at 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | at 1, 6, 24, 48, 72 hours after surgery |
| consumption of opioid converted to IV morphine equivalents |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huifang Jiang, M.D. | Zhejiang Caner Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32578192 | Background | 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. | |
| 36102582 | Derived | Gu 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. |
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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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permanent validity
Baidu Netdisk code：3i81
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| Thoracic epidural analgesia | Procedure | 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. |
|
opioids given postoperatively converted to IV morphine equivalents |
| 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. | during 72 hours after surgery |
| The incidence of postoperative hypotension | Adverse reactions related to analgesia | during 72 hours after surgery |
| The incidence of nausea and vomiting | Adverse reactions related to analgesia | during 72 hours after surgery |
| The incidence of pruritus | Adverse reactions related to analgesia | during 72 hours after surgery |
| The incidence of respiratory depression | Adverse reactions related to analgesia | during 72 hours after surgery |
| Time to ambulation in days | Postoperative ambulation time | through study completion, an average of 2-3 days |
| Time to eat in days | Time to start eating after surgery | through study completion, an average of 2-3 days |
| Time to flatus in hours | Time to flatus after surgery | through study completion, an average of 40-50 hours |
| Time to defecation in hours | Time to defecation after surgery | through study completion, an average of 60-70 hours |
| Time to urethral catheter removal in hours | Time tourethral catheter removal after surgery | through study completion, an average of 60-70 hours |
| Postoperative hospital stay in days | The time from operation to discharge | 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 | One month after surgery |
| ID | Term |
|---|---|
| D013662 | Tea |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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