Clinical trial · Interventional
Continous Popliteal Block for Microvascular Free Flap Reconstruction in Ear, Nose and Throat Surgery
Does Continuous Popliteal Nerve Block Improve Pain Management for Patients Undergoing Major Maxilla or Mandible Resection With Microvascular Reconstruction Using a Free Fibula Graft
NCT03607227CI-TRIAL-00051110completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the study is to assess the effects of a continuous popliteal block on postoperative pain and recovery after major ear, nose and throat surgery with microvascular free flap reconstruction using a fibula graft.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Pain, Musculoskeletal | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Levobupivacaine | Drug | — | UNRESOLVED |
| Saline Solution | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Local anesthetic
- description
- Levobupivacaine 3.75 mg/ml 15 ml is given as a bolus injection at start of surgery, followed by ropivacaine 2 mg/ml continous infusion 5-8 ml/h from the end of surgery until end of intervention at the fourth to seventh postoperative day.
- interventionNames
- Drug: Levobupivacaine
- type
- PLACEBO_COMPARATOR
- label
- Saline
- description
- Saline solution (NaCl 0.9%) is given in equivalent intervals and doses as in the active substance arm.
- interventionNames
- Drug: Saline Solution
Primary outcomes (1)
- measure
- Postoperative pain assessed by VAS (ranging from 0 (no pain) to 10 (worst possible pain)).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients at Skåne University hospital department of ear, nose and throat surgery undergoing major resection of maxilla or mandible and reconstruction using free fibula graft. * Preoperatively able to walk (with or without aid). Exclusion Criteria: * Neurological disease or peripheral neuropathy affecting the donor leg of the fibula graft. * Conditions of coagulopathy, or treatment with anticoagulant drugs, that contraindicates peripheral nerve block according to local guidelines. * Local anesthetic allergy. * Inability to understand study information or answer questions.
References
Publications (5)
- BACKGROUNDMarur S, Forastiere AA. Head and Neck Squamous Cell Carcinoma: Update on Epidemiology, Diagnosis, and Treatment. Mayo Clin Proc. 2016 Mar;91(3):386-96. doi: 10.1016/j.mayocp.2015.12.017. PMID 26944243
- BACKGROUNDRagbir M, Brown JS, Mehanna H. Reconstructive considerations in head and neck surgical oncology: United Kingdom National Multidisciplinary Guidelines. J Laryngol Otol. 2016 May;130(S2):S191-S197. doi: 10.1017/S0022215116000621. PMID 27841135
- BACKGROUNDDort JC, Farwell DG, Findlay M, Huber GF, Kerr P, Shea-Budgell MA, Simon C, Uppington J, Zygun D, Ljungqvist O, Harris J. Optimal Perioperative Care in Major Head and Neck Cancer Surgery With Free Flap Reconstruction: A Consensus Review and Recommendations From the Enhanced Recovery After Surgery Society. JAMA Otolaryngol Head Neck Surg. 2017 Mar 1;143(3):292-303. doi: 10.1001/jamaoto.2016.2981. PMID 27737447
- BACKGROUNDBorgeat A, Blumenthal S, Lambert M, Theodorou P, Vienne P. The feasibility and complications of the continuous popliteal nerve block: a 1001-case survey. Anesth Analg. 2006 Jul;103(1):229-33, table of contents. doi: 10.1213/01.ane.0000221462.87951.8d. PMID 16790658
- BACKGROUNDWhite PF, Issioui T, Skrivanek GD, Early JS, Wakefield C. The use of a continuous popliteal sciatic nerve block after surgery involving the foot and ankle: does it improve the quality of recovery? Anesth Analg. 2003 Nov;97(5):1303-1309. doi: 10.1213/01.ANE.0000082242.84015.D4. PMID 14570643