A Prospective, Randomized, Open-Label Study Comparing an Opioid-Sparing Postsurgical Pain Management Protocol With and Without Liposomal Bupivacaine for Full-Arch Implant Surgery
| Autor: | Phillip T. Iero, Ole T. Jensen, Tom Berry, Hassan Danesi, Samuel J. Razook, David R. Mulherin |
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| Rok vydání: | 2018 |
| Předmět: |
Adult
Male Lidocaine law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial 030202 anesthesiology law medicine Humans Pain Management Prospective Studies Anesthetics Local Adverse effect Prospective cohort study Aged Pain Measurement Dental Implants Bupivacaine Pain Postoperative business.industry 030206 dentistry General Medicine Middle Aged Liposomal Bupivacaine Analgesics Opioid Opioid Anesthesia Liposomes Female Dental Prosthesis Implant-Supported Oral Surgery business Oxycodone medicine.drug |
| Zdroj: | The International Journal of Oral & Maxillofacial Implants. 33:1155-1164 |
| ISSN: | 0882-2786 |
| DOI: | 10.11607/jomi.5938 |
| Popis: | Purpose Mild to moderate pain is common following dental implant surgeries, although severe pain is reported in some patients. This randomized, open-label trial was designed to determine the efficacy and safety of an opioid-sparing postsurgical pain management protocol with or without local infiltration of liposomal bupivacaine for full-arch implant surgery. This procedure is used in edentulous and/or failing dentition patients and involves securing four or more implants to the maxilla and/or mandible to serve as anchors for dental prostheses. Materials and methods Patients scheduled to undergo full-arch implant surgery were randomly assigned to receive an opioid-sparing postsurgical pain management protocol with or without liposomal bupivacaine 266 mg at the end of surgery. All patients received infiltration with ≤ 40 mL lidocaine 2% with epinephrine at the beginning of surgery and bupivacaine 0.5% with epinephrine near the end of surgery and oral opioid or nonopioid analgesics (oxycodone 5 mg tablets or ibuprofen 600 mg), as needed, postsurgically. Pain severity at the surgical site was assessed using a verbal 0 to 10 numeric rating scale (0 [no pain] to 10 [worst pain imaginable]). Patients separately assessed pain in their mandible and maxilla. Reports of treatment-emergent adverse events were collected. Results Sixty-nine patients were randomized to the liposomal bupivacaine 266 mg (n = 34) or control group (n = 35). At all time points postsurgery for both the mandible (all P ≤ .0112) and the maxilla (all P ≤ .0083), the liposomal bupivacaine group reported significantly less cumulative pain than the control group. At the conclusion of the 7-day follow-up, patients in the liposomal bupivacaine group experienced one-third less cumulative postsurgical pain than patients in the control group. Seventy-seven percent of patients in the liposomal bupivacaine group and 80% in the control group experienced a treatment-emergent adverse event. A higher percentage of patients in the liposomal bupivacaine versus control group reported itching (15% vs 9%) and constipation (38% vs 23%). Conclusion Patients receiving an opioid-sparing postsurgical pain management protocol with liposomal bupivacaine 266 mg experienced a statistically significant reduction of postsurgical pain and clinically relevant reduction in opioid consumption. The overall incidence of treatment-emergent adverse events was comparable in patients receiving an opioid-sparing postsurgical pain management protocol with or without liposomal bupivacaine. |
| Databáze: | OpenAIRE |
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