drugset / Trial / NCT06137924
Intraoperative Autonomic Neural Blockade
RandomizedParallel-groupDouble-blindSupportive care
Summary
The duration of the effect of autonomic neural blockade (ANB) is the most critical limitation for successful clinical application. The analgesic effect using only 0.5% bupivacaine may wear off after 12 to 18 hours. We have prolonged this effect using a combination of bupivacaine and dexamethasone. In this protocol, we aim to study three different local anesthetic combinations to prolong the effect of the ANB.
Timeline
- Start
- 2023-12-02
- Primary completion
- 2024-04-02
- Completion
- 2024-05-02
Publications
- Background Daes J, Morrell DJ, Hanssen A, Caballero M, Luque E, Pantoja R, Luquetta J, Pauli EM. Paragastric Autonomic Neural Blockade to Prevent Early Visceral Pain and Associated Symptoms After Laparoscopic Sleeve Gastrectomy: a Randomized Clinical Trial. Obes Surg. 2022 Nov;32(11):3551-3560. doi: 10.1007/s11695-022-06257-9. Epub 2022 Sep 2.
- Background Daes J, Pantoja R, Luquetta J, Luque E, Hanssen A, Rocha J, Morrell DJ. Impact on Anesthetic Agent Consumption After Autonomic Neural Blockade as Part of a Combined Anesthesia Protocol: A Randomized Clinical Trial. Anesth Analg. 2024 Sep 1;139(3):581-589. doi: 10.1213/ANE.0000000000006769. Epub 2023 Dec 13.
- Background Daes J, Rocha J, Luque E, Hanssen A. Comparative effectiveness of bupivacaine- dexamethasone and liposomal bupivacaine for autonomic neural blockade in laparoscopic sleeve gastrectomy: a study on pain, postoperative nausea and vomiting and analgesic consumption. British journal of surgery. Abstract presented at 2023 IBC-University of Oxford World Congress; British Journal of Surgery Oral Abstract Prize Session. Oxford University; London, UK. September 20, 2023. Forthcoming 2023.
- Daes J, Pantoja R, Luque E, Hanssen A, Rocha J, Pauli EM. Intraoperative autonomic neural blockade: comparison between different local anesthetics combinations: a randomized clinical trial. Surg Endosc. 2025 Apr;39(4):2523-2533. doi: 10.1007/s00464-025-11637-0. Epub 2025 Mar 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clonidine | Other / unclassified | 0.15 mg | Other |
| Subject | Dexamethasone | Small molecule | 8 mg | Other |
| Subject | Dexamethasone | Small molecule | 8 mg | — |
| Subject | Gelofusin | Unknown | 10 ml | — |
| Background | Bupivacaine | Other / unclassified | 0.5 % | Other |
| Background | Bupivacaine | Other / unclassified | 0.5 % | — |
| Background | Bupivacaine | Other / unclassified | 20 ml | Other |
| Background | Bupivacaine | Other / unclassified | 20 ml | — |
Indications
No indication recorded.