Controlled clinical trial of two parallel groups, with random assignment 1:1, non-inferiority, blinded for the patient, for who administers the intervention and for who analyzes the data. 112 participants
Controlled clinical trial of two parallel groups, with random assignment 1:1, non-inferiority, blinded for the patient, for who administers the intervention and for who analyzes the data. 112 participants Outcomes: Primary: Numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain) was used for pain assessments daily for 15 days and subsequently monthly until completing 3 months. Co-primary: Assessment of symptomatology related to phantom limb pain daily for 15 days POP and subsequently monthly until completing 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
112
Bony landmarks and the space between the lower lumbar vertebrae are identified. Subsequently, infiltration of the skin and subcutaneous cellular tissue with local anesthetic (Lidocaine 2% without epinephrine) is performed at the site to be punctured. A 17G Tuohy needle is inserted 2-4 cm through the skin, then the mandrel is removed, the low-resistance syringe is connected, and the loss of resistance is checked using the air or liquid technique, depending on the preference of the anesthesiologist. . Appreciating the loss of resistance in the embolus, the mandrel is then withdrawn and the epidural catheter is advanced to leave it an additional 5 cm inside the epidural space.
The patient is placed in the prone or supine position with the limb to be blocked flexed at 90°. Using a high-frequency linear transducer and using sterile technique, the popliteal sciatic nerve is identified in an axial axis. A 17G Tuohy needle is inserted plane and medial. Saline solution (5 ml) is applied to open the perineural space. Adequate hydrodissection and donut sign in the nerve are observed..A perineural catheter is then advanced 5 cm beyond the tip of the needle. The catheter is fixed with stitches and a transparent sterile dressing is placed.
Antioquia´s University
Medellín, Colombia
Posoperative Pain
Pain score according to the daily NRS scale (Numeric Pain Rating Scale), Numeric Pain Rating Scale, for 15 days POP and subsequently monthly until completing 3 months. is scores from 0 to 10, 10 being the worst value.
Time frame: 3 months
Phantom Limp Pain
For this qualitative dichotomous outcome, you will ask about symptomatology referring to phantom limb pain for 15 days POP and subsequently monthly until completing 3 months, It will be qualified as positive if it presents any neuropathic symptom.
Time frame: 3 months
Phantom Limp Pain first Year
Presence of phantom limb pain on a monthly basis until completing 12 month, The patient will be asked about the appearance of any painful sensation described as stabbing, shooting, electric shock, dull, tight pain and/or cramp in the anatomical site where the amputated limb would be, evaluating the presence or absence of the same (s). This will be questioned every day for 15 POPs days and monthly follow-up will continue via telephone until completing 3 months.
Time frame: 1 year
Opioid Consumption
the total consumption in mg of morphine or its equivalent at 12, 24 and 36 h POP will be evaluated.
Time frame: 36 hours
Incidence of nausea and vomiting POP
Incidence of nausea and vomiting POP in each group: the appearance of nausea or vomiting at 12, 24 and 36 h POP will be asked.
Time frame: 36 hours
Incidence of adverse effects
any appearance of hematoma, hypotension (defined as SBP less than 90 mmHg or a 30% decrease in baseline MAP) or bradycardia (HR less than 60 bpm) is defined.
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Time frame: 1 year
Days of hospital stay
Days of hospital stay through study completion
Time frame: during the time of hospitalization, on average 10 days
Mortality
Mortality in the first Year
Time frame: 1 year