Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04053491
Other study ID # CHUBX 2019/04
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 2019
Est. completion date October 2020

Study information

Verified date March 2023
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prospective randomized study comparing the axillary and the infraclavicular approaches for continuous brachial plexus block after hand surgery.


Description:

Regional anesthesia is considered as the gold standard for analgesia and anesthesia of hand surgeries. However, with a single-shot technique, a maximum of 13 hours of analgesia is obtained, even with a long-acting local anesthetic and adjuvants. For painful surgeries necessitating prolonged analgesia of more than 24 hours, continuous regional analgesia techniques have been described, using perinervous catheters. However, these techniques have a high incidence of failure. The most frequent causes of failure are catheter displacements, misplacement, and the distance between the targeted nerves. Many approaches have been described to insert these catheters (axillary, infraclavicular and supraclavicular), but the optimal approach remains unknown. Therefore, international and even local practices vary widely. Investigators plan to compare the axillary and the infraclavicular approaches in this randomized study, on 60 patients. In every group, an initial bolus will be given and then a perinervous catheter will be inserted by the allocated approach. The surgery will be done under regional anesthesia. The co-analgesia, the local anesthetic infusion and the follow-up will be standardized and will be the same in the two groups. The primary outcome will be an anesthesia score on 16 points previously described in other similar publication. The primary outcome will be at 24 hours after block realization, but it will be repeated at 48 hours. It will evaluate the degree of sensitive and motor blockade of every major nerve of the hand. Secondary outcomes will be the time, comfort and adverse effects of the technique, and postoperative pain, analgesia, satisfaction and adverse effects. The aim of this study is to help determine the optimal approach for brachial plexus catheter insertion, in order to improve analgesia, to decrease morphine consumption and its related adverse effects, and to improve patients and caregivers satisfaction.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 2020
Est. primary completion date October 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients with a social insurance number - ASA 1-3 - Patients undergoing hand surgery requiring a continuous brachial plexus block - Elective or urgent surgery - Effective contraception (HAS criteria) - Informed consent Exclusion Criteria: - Contraindication to the installation of a continuous brachial plexus block (coagulopathy, refusal, allergy to the medication) - Preexisting neuropathy - Pregnancy - Arteriovenous fistula - Obesity (BMI >40) - Another surgical site implicated during the surgery - Incapacity to abduct the operated arm - Preoperative use of morphine or equivalent

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Hand surgery under regional anesthesia
In both groups, patients will benefit from an initial standardized bolus (long-acting local anesthetic, ropivacaine) to cover the operative period, via the allocated approach. Ultrasound guidance and the recommended standards monitors will be used in both groups. After the initial bolus, a catheter will be inserted via the allocated approach. Surgery will be done under regional anesthesia alone, unless there is a medical contraindication or if the patient asks for general anesthesia. Post-operative analgesia will be standardized with regular paracetamol, regular NSAID (Nonsteroidal anti-inflammatory drugs) and oxycodone if needed. The local anesthetics perfusion will be standardized. There will be a medical follow up at 24 and 48 hours where data will be collected.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Outcome

Type Measure Description Time frame Safety issue
Primary Anesthesia score Min/Max : 0 for no anesthesia to 16 total anesthesia Addition of Motor block score (0-2) and Sensitive block score (0-2) for the 4 main nerves of the hand 24 hours after block realization
Secondary Duration of catheter insertion procedure During block realization
Secondary Maximal pain during the surgery procedure Measured by patient with numeric scale from 0 = no pain to 10 = maximal pain During surgery
Secondary Maximal pain during the first 24 hours Measured by patient with numeric scale from 0 = no pain to 10 = maximal pain During the first 24 hours after block realization
Secondary Anesthesia score Min/Max : 0 for no anesthesia to 16 total anesthesia Addition of Motor block score (0-2) and Sensitive block score (0-2) for the 4 main nerves of the hand 30 minutes after block realization
Secondary Anesthesia score Min/Max : 0 for no anesthesia to 16 total anesthesia Addition of Motor block score (0-2) and Sensitive block score (0-2) for the 4 main nerves of the hand 48 hours after block realization
Secondary Total morphine consumption 24 and 48 hours after block realization
Secondary Mean pain at rest and with movement Measured by patient with numeric scale from 0 = no pain to 10 = maximal pain 24 and 48 hours after block realization
Secondary Quality of sleep Measured by patient with numeric scale from 0 = insomnia to 10 = excellent sleep Over first night after block realization
Secondary Patient satisfaction Measured by patient with numeric scale from 0 = fully unsatisfied to 10 = fully satisfied 48 hours after block realization
See also
  Status Clinical Trial Phase
Completed NCT03211949 - Ultrasound Guided Topographic Mapping of Medial Antebrachial Cutaneous Nerve N/A
Suspended NCT03291691 - Protective Nerve Stimulation in Regional Anesthesia
Completed NCT03270033 - Intravenous Dexmedetomidine, Dexamethasone and Interscalene Block Duration After Arthroscopic Shoulder Surgery Phase 4
Recruiting NCT06015204 - Assessment of the C8 Dermatomal Block With Photoplethysmographic Amplitude After Interscalene Brachial Plexus Block N/A
Not yet recruiting NCT03279679 - Comparison Between Costoclavicular and Paracoracoid Ultrasound-guided Infraclavicular Block for Forearm Surgery N/A
Completed NCT02305875 - The Musculocutaneous Nerve in a High Resolution MRI N/A
Completed NCT03688724 - Perioperative Diaphragm Point of Care Ultrasound
Completed NCT05005260 - Liposomal Bupivacaine Single-Injection Interscalene Block vs. Continuous Interscalene Block for Primary Total Shoulder Arthroplasty Phase 4
Completed NCT02462408 - Conventional Versus Posterior Approach in Ultrasound-Guided Parasagittal In-Plane Infraclavicular Brachial Plexus Block N/A
Completed NCT02312453 - Posterior Parasagittal In-Plane Ultrasound-Guided Infraclavicular Brachial Plexus Block N/A
Completed NCT00321425 - Ultrasound Guidance Vs. Electrical Nerve Stimulation for Infraclavicular Brachial Plexus Block N/A
Recruiting NCT03577860 - Ventilation and Pulmonary Aeration, Electrical Impedance Tomography, Interscalene Brachial Plexus Block N/A
Completed NCT04356521 - Lateral Sagittal vs Costoclavicular Approach for Ultrasound-Guided Infraclavicular Block N/A
Completed NCT04463329 - Jedi Grip vs. Double Operator Technique for Axillary Brachial Plexus Block N/A
Not yet recruiting NCT04784104 - Comparison of Infraclavicular And Supraclavicular Block Phase 4
Terminated NCT03785392 - Out of Plane Approach for Interscalene N/A
Completed NCT02787018 - Dexamethasone Compared With Dexmedetomidine as an Adjuvant to Ropivacaine for Supraclavicular Brachial Plexus Block Phase 3
Completed NCT03514342 - The Effects of Horner's Syndrome Developing After Interscalene Brachial Plexus Block on Autonomic Nervous Activity
Completed NCT05315271 - Supraclavicular Brachial Plexus Block During Upper Limb Surgeries Early Phase 1
Completed NCT04694105 - Peri-neural Dexmedetomidine Versus Dexamethasone for Supraaclavicular Block Adjuvant to Bupivacaine Supraclavicular Brachial Plexus Block N/A