Continuous Sciatic Nerve Block vs Epidural Analgesia in Lower Limb Amputation for Postoperative Pain

NCT05608733 | Unknown Phase 3

• 1 other identifier: IN-47-2021
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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

Conditions

Phantom Limb Pain; Pain, Chronic

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Phantom Limp Pain first Year

  1 year

• Opioid Consumption

  36 hours

• Incidence of nausea and vomiting POP

  36 hours

• Incidence of adverse effects

  1 year

• Days of hospital stay

  during the time of hospitalization, on average 10 days

Other Outcomes (1)

• Posoperative Satisfaction

  36 hours

Study Arms (2)

Epidural catheter

EXPERIMENTAL

Epidural catheter infusion of bupivacaine 0.1% (4-6 cc/h) at level L3-L4

Drug: Epidural catheter

Continuous sciatic nerve block

ACTIVE COMPARATOR

Continuous sciatic catheter infusion of bupivacaine 0.1% (6-10 cc/h)

Drug: Continuous sciatic nerve block

Interventions

Epidural catheter DRUG

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 Appreciating the loss of resistance in the embolus, the mandrel is then withdrawn and the epidural catheter is advanced to leave it an additional 5 cm inside the epidural space.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

Epidural catheter

Continuous sciatic nerve block DRUG

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

Continuous sciatic nerve block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Antioquia: lead

Study Sites (1)

Antioquia´s University

Medellín, Colombia

Location

Related Publications (3)

• 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.

  PMID: 31248645 BACKGROUND

• 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.

  PMID: 29973967 BACKGROUND

• 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.

  PMID: 12579385 BACKGROUND

MeSH Terms

Conditions

Phantom Limb; Chronic Pain

Interventions

Analgesia, Epidural

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Mario Zamudio, Prof

  IPS universitaria

  STUDY DIRECTOR

Central Study Contacts

Daniela González, Md

CONTACT

3122690961; daniela.gonzalezg@udea.edu.co

Laura Lopez Agudelo, Md

CONTACT

3148874442; laura.lopez9@udea.edu.co

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: November 8, 2022
• Study Start: December 1, 2022
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: November 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)