Continuous Sciatic Nerve Block vs Epidural Analgesia in Lower Limb Amputation for Postoperative Pain
- Conditions
- Phantom Limb PainPain, Chronic
- Interventions
- Drug: Continuous sciatic nerve blockDrug: Epidural catheter
- Registration Number
- NCT05608733
- Lead Sponsor
- Universidad de Antioquia
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 112
- Age over 18 years
- Being scheduled for above or below knee amputation or for bone remodeling of lower limb amputees
- Acceptance of continuous regional analgesic technique as part of their multimodal analgesia
- Traumatic cause of amputation
- Allergy to local anesthetics
- Contraindication for epidural technique or continuous blocks
- Stage 5 kidney disease
- Concomitant use of aspirin and clopidogrel
- Pregnancy status
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Continuous sciatic nerve block Continuous sciatic nerve block Continuous sciatic catheter infusion of bupivacaine 0.1% (6-10 cc/h) Epidural catheter Epidural catheter Epidural catheter infusion of bupivacaine 0.1% (4-6 cc/h) at level L3-L4
- Primary Outcome Measures
Name Time Method Posoperative Pain 3 months 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.
Phantom Limp Pain 3 months 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.
- Secondary Outcome Measures
Name Time Method Incidence of nausea and vomiting POP 36 hours 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.
Phantom Limp Pain first Year 1 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.
Opioid Consumption 36 hours the total consumption in mg of morphine or its equivalent at 12, 24 and 36 h POP will be evaluated.
Incidence of adverse effects 1 year 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.
Days of hospital stay during the time of hospitalization, on average 10 days Days of hospital stay through study completion
Mortality 1 year Mortality in the first Year
Trial Locations
- Locations (1)
Antioquia´s University
🇨🇴Medellin, Colombia