Pain, Chronic Clinical Trial
— AmpupainOfficial title:
Continuous Sciatic Nerve Block vs Epidural Analgesia in Lower Limb Amputation for Prevention of Acute Postoperative Pain and Phantom Limb Pain: A Triple-blind Randomized Controlled Non-inferiority Clinical Trial.
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
Status | Not yet recruiting |
Enrollment | 112 |
Est. completion date | July 2025 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age over 18 years 2. Being scheduled for above or below knee amputation or for bone remodeling of lower limb amputees 3. Acceptance of continuous regional analgesic technique as part of their multimodal analgesia Exclusion Criteria: 1. Traumatic cause of amputation 2. Allergy to local anesthetics 3. Contraindication for epidural technique or continuous blocks 4. Stage 5 kidney disease 5. Concomitant use of aspirin and clopidogrel 6. Pregnancy status |
Country | Name | City | State |
---|---|---|---|
Colombia | Antioquia´s University | Medellin |
Lead Sponsor | Collaborator |
---|---|
Universidad de Antioquia |
Colombia,
De Jong R, Shysh AJ. Development of a Multimodal Analgesia Protocol for Perioperative Acute Pain Management for Lower Limb Amputation. Pain Res Manag. 2018 Jun 3;2018:5237040. doi: 10.1155/2018/5237040. eCollection 2018. Review. — View Citation
Edgley C, Hogg M, De Silva A, Braat S, Bucknill A, Leslie K. Severe acute pain and persistent post-surgical pain in orthopaedic trauma patients: a cohort study. Br J Anaesth. 2019 Sep;123(3):350-359. doi: 10.1016/j.bja.2019.05.030. Epub 2019 Jun 24. — View Citation
Gehling M, Tryba M. [Prophylaxis of phantom pain: is regional analgesia ineffective?]. Schmerz. 2003 Jan;17(1):11-9. German. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 |
36 hours | |
Primary | 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. | 3 months | |
Primary | 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. | 3 months | |
Secondary | 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. | 1 year | |
Secondary | Opioid Consumption | the total consumption in mg of morphine or its equivalent at 12, 24 and 36 h POP will be evaluated. | 36 hours | |
Secondary | 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. | 36 hours | |
Secondary | 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. | 1 year | |
Secondary | Days of hospital stay | Days of hospital stay through study completion | during the time of hospitalization, on average 10 days | |
Secondary | Mortality | Mortality in the first Year | 1 year |
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