A Phase 3 interventional study of Epidural catheter and Continuous sciatic nerve block in Phantom Limb Pain and Pain, Chronic, sponsored by Universidad de Antioquia. Not yet recruiting at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-08.
Sponsored by Universidad de Antioquia · Phase 3, Interventional, and Prevention
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.
163 studies on the registry are indexed under Phantom Limb; 35 are open to participants now.
This study's planned enrollment of 112 is above the median of 30 across 125 interventional studies indexed under Phantom Limb.
Browse Phantom Limb studies →Universidad de Antioquia is the lead sponsor of 80 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Epidural catheter infusion of bupivacaine 0.1% (4-6 cc/h) at level L3-L4
Drug: Epidural catheter
Continuous sciatic catheter infusion of bupivacaine 0.1% (6-10 cc/h)
Drug: Continuous sciatic nerve block
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.
Also known as: Epidural Analgesia
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.
Also known as: Periferical continuous block
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.
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
Posoperative Satisfaction
Postoperative satisfaction measured with the EVAN LR scale (evaluation of local anesthetic satisfaction). It consists of a self-reported scale that measures satisfaction in the postoperative period of patients undergoing regional anesthesia in different surgical models (51), with an evaluation of 19 items structured in a global index and five unweighted dimensions, each of which covers some aspects such as Attention (4 items), Information (5 items), Discomfort (4 items), Waiting (2 items) and Pain (4 items). has a score for questions between 20 and 100 points, the lower the score, the lower satisfaction by dimension
Time frame: 36 hours
Plan to share: No — public bases of data
Start is estimated for Dec 2022; primary completion for May 2025, 29 months later.
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Universidad de Antioquia