None listed
Conditions
Brief summary
Functional outcomes of peripheral nerve injury using standard microsurgical repair alone are extremely poor despite the tremendous advances in surgery and medicine. These poor outcomes are due to the slow nerve regeneration process through the injury site and further growth to the target sites (muscle motor units, sensory and propioreceptors). In simple language, the muscle is an electric motor that needs continual supply of electricity to keep it running in good condition. The nerve is the electric wire and the nerve impulse is the electricity. When there is an injury to the nerve the electric wire is divided and the motor cannot work. The motor will deteriorate and weaken irreversibly if the re-establishment of electricity supply is too slow. When the electricity supply is re-established within a time interval short enough to prevent irreversible damage of the motor, the reconditioned and weaken motor will run again. We hypothesise that the process of regeneration can be enhanced and sped up by electrical stimulation of the repaired nerve intraoperatively. We plan to test this hypothesis in patients suffering from ulnar and median nerve injury. They will undergo microsurgical repair of the nerve under general aesthetic as routine practice and then receive intra-operative low frequency electric stimulation of the repaired nerve for 1 hour. Functional outcomes of patients randomised to receive the experimental treatment will be compared with controls (patients who receive nerve repair alone) over the course of a 24 month follow up period allowing us to determine if the added therapy translates into clinically beneficial outcomes.
Interventions
All patients will undergo microsurgical coaptation of injured peripheral nerves by the standard surgical technique with interrupted monofilament nylon suture of the epineruium. In our experimental group the repaired nerve will be stimulated by applying low frequency electric pulses to the nerve for 1 hour. After standard microsurgical repair of median or/and ulnar nerve injury is performed, two sterilized, stainless steel wires are placed proximal and distal to the coaptation site. These are se
All patients will undergo microsurgical coaptation of injured peripheral nerves by the standard surgical technique with interrupted monofilament nylon suture of the epineruium. In our experimental group the repaired nerve will be stimulated by applying low frequency electric pulses to the nerve for 1 hour. After standard microsurgical repair of median or/and ulnar nerve injury is performed, two sterilized, stainless steel wires are placed proximal and distal to the coaptation site. These are secured to the skin with surgical suture material. The proximal wire is connected to the cathode and the distal wire to the anode port of the source of current calibrated to 20Hz balanced biphasic pulses, voltage: 3 volts, 1mA to 5mA current, duty cycle of 0.2%, continuous. Patients included in the trial will receive Low frequency continuous electric stimulation of the nerve for 1 hour as per protocol. In the placebo group, subjects will receive 5 seconds of similar intensity ES but the stimulator will be turned off for the remainder of the hour. In the mean time, surgical repair of other injury structures is performed. It is well documented that isolated traumatic nerve injury is frequently associated to vascular and musculoskeletal injuries. Standard closure of skin is performed . Electric stimulation wires are removed and standard dressings and immobilization applied. The entire procedure is performed under a general anaesthetic.
Sponsors
Jeremy Wiseman
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 to 70 years 2. Complete transection of the medial or/and ulnar nerve proximal to the wrist level. 3. Receiving surgery within 72 hours after injury. 4. Standard primary end-to-end nerve repair 5. Clinical indication for surgery under general anesthesia. 6. Informed, voluntary verbal and written consent obtained from patients.
Exclusion criteria
1. Devascularization or amputation 2. Multilevel or segmental nerve injury 3. Diabetic and other polyneuropathies. 4. Cognitive impairment.
Outcome results
None listed