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

NCT ID: NCT05608733

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2025-07-31

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.

Conditions

Phantom Limb Pain; Pain, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Epidural catheter

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

Group Type: EXPERIMENTAL

Epidural catheter

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 Appreciating the loss of resistance in the embolus, the mandrel is then withdrawn and the epidural catheter is advanced to leave it an additional 5 cm inside the epidural space.

Continuous sciatic nerve block

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

Group Type: ACTIVE_COMPARATOR

Continuous sciatic nerve block

Intervention Type: 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.

Interventions

Epidural catheter

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.

Intervention Type: DRUG

Continuous sciatic nerve block

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.

Intervention Type: DRUG

Other Intervention Names

Epidural Analgesia; Periferical continuous block

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Antioquia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mario Zamudio, Prof

Role: STUDY_DIRECTOR

IPS universitaria

Locations

Antioquia´s University

Medellín, , Colombia

Countries

Colombia

Central Contacts

Daniela González, Md

Role: CONTACT

daniela.gonzalezg@udea.edu.co

3122690961

Laura Lopez Agudelo, Md

Role: CONTACT

laura.lopez9@udea.edu.co

3148874442

References

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.

Reference Type: BACKGROUND

PMID: 31248645 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29973967 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12579385 (View on PubMed)

Other Identifiers

IN-47-2021

Identifier Type: -

Identifier Source: org_study_id