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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pain, Chronic; Phantom Limb Pain
• Intervention / Treatment: Drug: Epidural catheter; Drug: Continuous sciatic nerve block

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.

• Study Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Daniela González, Md; Phone Number: 3122690961; Email: daniela.gonzalezg@udea.edu.co
• Study Contact Backup: Name: Laura Lopez Agudelo, Md; Phone Number: 3148874442; Email: laura.lopez9@udea.edu.co

Study Locations

• Colombia
  • Medellin, Colombia
    • Antioquia´s University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Epidural catheter; Epidural catheter infusion of bupivacaine 0.1% (4-6 cc/h) at level L3-L4	Drug: 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.; Other Names: Epidural Analgesia
Active Comparator: Continuous sciatic nerve block; Continuous sciatic catheter infusion of bupivacaine 0.1% (6-10 cc/h)	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.; Other Names: Periferical continuous block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Opioid Consumption	the total consumption in mg of morphine or its equivalent at 12, 24 and 36 h POP will be evaluated.	36 hours
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
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
Days of hospital stay	Days of hospital stay through study completion	during the time of hospitalization, on average 10 days
Mortality	Mortality in the first Year	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universidad de Antioquia
• Investigators: Study Director: Mario Zamudio, Prof, IPS Universitaria

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): May 1, 2025
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Pain, Postoperative; Chronic Pain; Phantom Limb
• Other Study ID Numbers: IN-47-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: public bases of data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No