Comparison of Liposomal Bupivacaine, Plain Bupivacaine, and Placebo for Transversus Abdominis Plane Blocks: A Randomized, Blinded Trial

• Applicant: Dr. Carolin Müller
• Subject Area: Anaesthesiology ; Gynaecology and Obstetrics
• Term: from 2022 to 2025
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 498537330

• Final Report Year: 2025

Final Report Abstract

Enhanced Recovery After Surgery (ERAS) pathways are designed to improve patient recovery by minimizing opioid use and related side effects. One method involves transversus abdominis plane (TAP) blocks, which deliver local anesthetics to nerves in the abdominal wall . While TAP blocks are commonly used, their effectiveness is debated, particularly in managing visceral pain or extending pain relief. Liposomal bupivacaine, a long-acting anesthetic, is often included in TAP blocks to prolong their duration, but its efficacy remains uncertain. This study investigated whether TAP blocks using liposomal bupivacaine reduce opioid use after major abdominal surgery compared to plain bupivacaine or placebo. The primary focus was on opioid consumption during the first 48 hours post-surgery. Secondary outcomes included time to sensation return, pain scores, and opioid use from 48–72 hours. 261 patients undergoing major abdominal surgery were randomly assigned to receive one of three treatments: 1) Liposomal bupivacaine, 2) Plain bupivacaine, 3) Placebo (normal saline). All groups had access to intravenous opioids for additional pain relief. Opioid use during the first 24 hours averaged 26 mg, 33 mg, and 31 mg (median values) for liposomal bupivacaine, plain bupivacaine, and placebo, respectively. Differences between groups were not statistically significant. Opioid consumption between 24–48 hours and secondary outcomes, including pain scores, sensation return, and opioid use from 48–72 hours, were also similar across groups. These findings suggest that TAP blocks, regardless of whether liposomal bupivacaine is used, may not significantly reduce opioid use or improve pain management after abdominal surgery. Clinicians may need to reconsider the routine use of TAP blocks and explore alternative pain management strategies. For patients, this highlights the importance of discussing individualized recovery plans with healthcare providers.

Publications

• Diagnostic performance of additional imaging tests for staging purposes in a bicentric German series of low-risk early breast cancer patients. Archives of Gynecology and Obstetrics, 309(4), 1475-1481.
  Jung, Lisa; Huwer, Sarah Isabelle; Taran, Florin-Andrei; Unger, Clara; Müller, Carolin; Solomayer, Erich-Franz; Juhasz-Böss, Ingolf & Neubauer, Jakob
  
• Improved awareness of physical activities is associated with a gain of fitness and a stable body weight in breast cancer patients during the first year of antineoplastic therapy: the BEGYN-1 study. Frontiers in Oncology, 13.
  Zemlin, Cosima; Schleicher, Julia Theresa; Altmayer, Laura; Stuhlert, Caroline; Wörmann, Carolin; Lang, Marina; Scherer, Laura-Sophie; Thul, Ida Clara; Spenner, Lisanne Sophie; Simon, Jana Alisa; Wind, Alina; Kaiser, Elisabeth; Weber, Regine; Goedicke-Fritz, Sybelle; Wagenpfeil, Gudrun; Zemlin, Michael; Steffgen, Georges; Solomayer, Erich-Franz & Müller, Carolin
  
• Prevalence and Relevance of Vitamin D Deficiency in Newly Diagnosed Breast Cancer Patients: A Pilot Study. Nutrients, 15(6), 1450.
  Zemlin, Cosima; Altmayer, Laura; Stuhlert, Caroline; Schleicher, Julia Theresa; Wörmann, Carolin; Lang, Marina; Scherer, Laura-Sophie; Thul, Ida Clara; Spenner, Lisanne Sophie; Simon, Jana Alisa; Wind, Alina; Kaiser, Elisabeth; Weber, Regine; Goedicke-Fritz, Sybelle; Wagenpfeil, Gudrun; Zemlin, Michael; Solomayer, Erich-Franz; Reichrath, Jörg & Müller, Carolin
  
• „Comparison of Central Venous Catheter Insertion Sites in Critically Ill Patients – A Quality Improvement Project” poster, ASA (American Society of Anesthesiologists) 10/2023, San Francisco
  Carolin Martina Müller
  
• A Plea for Monitoring Serum Selenium Levels in Breast Cancer Patients: Selenium Deficiency Is Rare during the First Year of Therapy, and Selenium Supplementation Is Associated with Elevated Risk of Overdosing. Nutrients, 16(13), 2134.
  Altmayer, Laura Alicia; Lang, Marina; Schleicher, Julia Theresa; Stuhlert, Caroline; Wörmann, Carolin; Scherer, Laura-Sophie; Thul, Ida Clara; Spenner, Lisanne Sophie; Simon, Jana Alisa; Wind, Alina; Tokcan, Mert; Kaiser, Elisabeth; Weber, Regine; Goedicke-Fritz, Sybelle; Wagenpfeil, Gudrun; Zemlin, Michael; Solomayer, Erich-Franz; Reichrath, Jörg; Müller, Carolin & Zemlin, Cosima
  
• Can Ki-67 serve as a suitable marker to indicate the necessity of staging diagnostics in cases of low-risk breast cancer?. Archives of Gynecology and Obstetrics, 311(2), 443-449.
  Jung, Lisa; Huwer, Sarah Isabelle; Jungmann, Peter; Medl, Markus; Taran, Florin-Andrei; Neubauer, Jakob; Wilpert, Carolin; Juhasz-Böss, Ingolf & Müller, Carolin
  
• Cerebral Metastases in Breast Cancer Patients: a Narrative Review. Current Breast Cancer Reports, 16(4), 389-401.
  Müller, Carolin; Schmidt, Gilda; Solomayer, Erich-Franz; Popp, Ilinca; Grosu, Anca-Ligia; Juhasz-Böss, Ingolf; Jung, Lisa & Huwer, Sarah
  
• Challenges of obesity in today's surgical healthcare. Journal of Clinical Anesthesia, 92, 111213.
  Müller, Carolin; Rosen, Michael J. & Ruetzler, Kurt
  
• Correlation of preoperative sonographic staging and postoperative histopathologic staging in patients with invasive breast cancer. Archives of Gynecology and Obstetrics, 310(5), 2623-2630.
  Mueller, Carolin; Zimmermann, Julia Sarah Maria; Radosa, Marc Philipp; Hahn, Anna Katharina; Kaya, Askin Canguel; Huwer, Sarah; Stotz, Lisa; Wagenpfeil, Gudrun; Radosa, Christoph Georg; Solomayer, Erich-Franz & Radosa, Julia Caroline
  
• Course of Vitamin D Levels in Newly Diagnosed Non-Metastatic Breast Cancer Patients over One Year with Quarterly Controls and Substitution. Nutrients, 16(6), 854.
  Zemlin, Cosima; Altmayer, Laura; Lang, Marina; Schleicher, Julia Theresa; Stuhlert, Caroline; Wörmann, Carolin; Scherer, Laura-Sophie; Thul, Ida Clara; Spenner, Lisanne Sophie; Simon, Jana Alisa; Wind, Alina; Kaiser, Elisabeth; Weber, Regine; Goedicke-Fritz, Sybelle; Wagenpfeil, Gudrun; Zemlin, Michael; Solomayer, Erich-Franz; Reichrath, Jörg & Müller, Carolin
  
• Impact of low HER2 expression on response to CDK4/6 inhibitor treatment in advanced HR + /HER2- breast cancer: a multicenter real-world data analysis. Archives of Gynecology and Obstetrics, 311(2), 423-427.
  Ralser, Damian J.; Kiver, Verena; Solomayer, Erich-Franz; Neeb, Caroline; Blohmer, Jens-Uwe; Abramian, Alina V.; Maass, Nicolai; Schütz, Florian; Kolberg-Liedtke, Cornelia; Müller, Carolin & Rambow, Anna-Christina
  
• Multidisciplinary surgical management of severe posterior compartment endometriosis. Surgical Endoscopy, 38(8), 4677-4679.
  Mueller, Carolin; Luna, Russo Miguel; Schabl, Lukas & Kessler, Hermann
  
• “Multidisciplinary surgical management of severe posterior compartment endometriosis. Surgical Endoscopy”, Video Reel Presentation, SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) Annual Meeting 4/2024, Cleveland, USA
  Carolin Martina Müller
  
• “Trends in the management of small HER2 positive breast cancers”, Online Abstract, ASCO (American Society of Clinical Oncology) Annual Meeting 5/2024, Chicago, USA
  Carolin Martina Müller
  
• „Outcomes in Patients with Chronic Kidney Disease Undergoing HIPEC for Ovarian Cancer” poster, SGO (Society of Gynecological Oncology) Annual Meeting 3/2024, San Diego, USA
  Carolin Martina Müller
  
• Feasibility and safety of hyperthermic intra-peritoneal chemotherapy in patients with ovarian cancer and chronic kidney disease. International Journal of Gynecological Cancer, 35(1), 100010.
  Mueller, Carolin; Smith, Gabriella; Yao, Meng; Kelley, Johanna; Chambers, Laura & DeBernardo, Robert