Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Lung Neoplasms

Recurrence

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Disease Attributes

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Anesthetics

Analgesics, Opioid

General anesthesia combined with epidural anesthesia

General-epidural anesthesia

Balanced general anesthesia and postoperative opioids

Andrea Kurz, M.D.

Test the effect of combined regiona/general anesthesia on lung cancer recurrence compared to general anesthesia alone.

Surgery is the primary treatment of lung cancer, but surgery releases tumor cells into the systemic circulation. Whether this minimal residual disease results in clinical metastases is a function of host defense. At least three perioperative factors shift the balance toward initiation and progression of minimal residual disease. (1) Surgery per se depresses cell-mediated immunity, reduces concentrations of tumor-related anti-angiogenic factors (e.g., angiostatin and endostatin), and increases concentrations of pro-angiogenic factors such as VEGF. (2) Anesthesia impairs numerous immune functions, including neutrophil, macrophages, dendritic cells, T lymphocytes (T-cell), and Natural killer cell (NK-cell) functions. (3) Opioid analgesics inhibit both cellular and humoral immune function in humans, and promote tumor growth in rodents. Regional analgesia attenuates each of these adverse effects. For example, regional anesthesia largely prevents the neuroendocrine stress response to surgery by blocking afferent neural transmission. With combined regional and general anesthesia/analgesia, the amount of general anesthetic required is much reduced - as is, presumably, immune suppression. And finally, regional analgesia provides superb pain relief, essentially obliterating the need for postoperative opioids. Animal studies show that regional anesthesia improves natural kill cell function and reduces the metastatic burden in animals inoculated with carcinoma cells. Preliminary retrospective data in cancer patients showed, that paravertebral analgesia for breast cancer surgery reduced risk of recurrence or metastasis by 40% during a 2.5 to 4-year follow-up period.

The investigators thus propose to evaluate the effect of combined epidural-general anesthesia compared to general anesthesia on cancer recurrence semi-annually over a period of 5 years.

Regional Anesthesia and Lung Cancer Recurrence

The Effect of Adding Intraoperative Regional Anesthesia on Cancer Recurrence in Patients Undergoing Lung Cancer Resection

The effect of regional versus general anesthesia on the primary outcome of disease-free survival (time to the earlier or recurrence or death from any cause)

Secondary outcomes measured at repeated perioperative time points, include NK cell function, immune-function markers (cytokines, cortisol) and pain.

The Cleveland Clinic

Principal Investigator

Infections

Wounds and Injuries

Immune System Diseases

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Communicable Diseases

Fractures, Bone

Hypersensitivity

Hallux Valgus

Bunion

Nails, Ingrown

Neuroma

Morton Neuroma

Congenital Abnormalities

Foot Deformities

Foot Deformities, Congenital

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Metatarsalgia

Foot Diseases

Joint Diseases

Neuralgia

Peripheral Nervous System Diseases

Neuromuscular Diseases

Pain

Neurologic Manifestations

Nail Diseases

Skin Diseases

Ropivacaine

Anesthetics, Local

Patient receiving a specific block of medial and lateral plantar nerves in order to preserve the calcaneal nerve

Specific injection of long duration local anesthetic in contact with medial and lateral plantar nerves.

Local anesthetic : Ropivacaine : 0,375% - 5 ml per nerve.

Specific block of medial and lateral plantar nerves

Sébastien Bloc, MD

Foot surgery is a painful surgery that is usually scheduled in outpatients. A good management of analgesia is the crucial point. Regional anesthesia (RA) is the gold standard, that provides good anesthesia and a long duration of analgesia. The sciatic nerve block (or its branches) is the most adapted analgesic technique.

Limitation of proximal sciatic block is the motor block of the ankle and results in the impossibility, for the patient, to walk during the early post-operative period. Distal block of the sciatic nerve (tibial and fibular nerve blocks), at the level of the ankle, has been proposed to maintain the mobility of the ankle, to make deambulation with crutches easier. Nevertheless, the lack of sensibility of the heel remains a limitation for early walking, even with adapted shoes (ie : Barouk).

A specific anesthesia of the distal part of the foot, respecting the heel, could be the best option to provide an early deambulation and a suitable analgesia.

Ultrasound identification and specific anesthesia of the branches supplying the distal part of the foot (medial and lateral plantar nerves) could meet this dual objective : good anesthesia and suitable analgesia for early deambulation.

This study is a feasibility study of a specific block of the plantar branches of the tibial nerve, to preserve the sensibility of the heel, in case of foot surgery. The safety of the procedure will be assessed according to the rate of postoperative dysesthesia.

Block of the medial and lateral plantar branches of the tibial nerve will be performed under the medial malleolar-calcaneal axis (MMCA) in order to preserve the calcaneal nerves.

Blocks of the deep peroneal nerve (DPN) and the superficial peroneal nerve (SPN) will be added to provide an adequate anesthesia.

Every block will be performed under Ultrasound using a 27-gauge, 5-cm, short bevel needle.

5 mL of 0.375% Ropivacaine will be injected for each block. The sensory blocks will be assessed by pinprick test and cold test every 10 minutes for 40 minutes in the following locations: Calcaneal nerves, Lateral plantar nerve and Medial plantar nerve.

The extent of sensory block will be graded as follows: 2: normal sensation; 1: decreased sensation; and 0: no sensation (complete block).

Feasibility of Specific Anesthesia of the Forefoot Preserving the Sensitivity of the Heel for Foot Surgery

Specific Block of the Plantar Branches of the Tibial Nerve Under Ultrasound for Foot Surgery : A Monocentric Pilot Study

Pinprick and cold test on the sole of the foot - Cartography of the sole - Ipsilateral versus Contralateral test Numeric Scale for Pin-Prick test and Cold test : 2: normal sensation, 1: decreased sensation, 0: total loss of sensation

Usage (or not) of an additional anesthetic procedure to perform the surgery

Numeric Rating Scale for Visualization : from 0 (very difficult) to 100 (very easy)

Numeric Rating Scale for Satisfaction : from 0 (very unsatisfied) to 100 (very satisfied)

Numeric Rating Scale for Pain : from 0 (no pain) to 100 (severe pain)

Questionnaire about toe mobility, foot sensitivity and potential sensory anomalies such as numbness, itching or tingling.

CMC Ambroise Paré

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Regional Anesthesia and Lung Cancer Recurrence	NCT01179308	Lung Cancer	General-epidura... Balanced genera...	18 Years - 85 Years	The Cleveland Clinic
Feasibility of Specific Anesthesia of the Forefoot Preserving the Sensitivity of the Heel for Foot Surgery	NCT03504462	Hallux Valgus a... Morton Neuroma Metatarsal Frac... Ingrown Nail Foot Wound Foot Infection	Specific block ...	18 Years -	CMC Ambroise Paré

Spots Global Cancer Trial Database for regional analgesia