Clinical trial NCT05608733: Continuous Sciatic Nerve Block vs Epidural Analgesia in Lower Limb Amputation for Postoperative Pain
Official 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Phantom Limb Pain
Pain, Chronic
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Posoperative Pain
timeFrame: 3 months
measure: Phantom Limp Pain
timeFrame: 3 months
Secondary outcomes:
measure: Phantom Limp Pain first Year
timeFrame: 1 year
measure: Opioid Consumption
timeFrame: 36 hours
measure: Incidence of nausea and vomiting POP
timeFrame: 36 hours
measure: Incidence of adverse effects
timeFrame: 1 year
measure: Days of hospital stay
timeFrame: during the time of hospitalization, on average 10 days
measure: Mortality
timeFrame: 1 year
Other outcomes:
measure: Posoperative Satisfaction
timeFrame: 36 hours
Locations:
city: Medellin
country: Colombia
facility: Antioquia´s University
Study officials:
affiliation: IPS universitaria
name: Mario Zamudio, Prof
role: STUDY_DIRECTOR
References:
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.
citation: 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.
citation: Gehling M, Tryba M. [Prophylaxis of phantom pain: is regional analgesia ineffective?]. Schmerz. 2003 Jan;17(1):11-9. doi: 10.1007/s00482-002-0198-2. German.