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

Pain, Chronic Clinical Trial

— Ampupain  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05608733
• Other study ID #: IN-47-2021
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 2022
• Est. completion date: July 2025

Study information

• Verified date: March 2022
• Source: Universidad de Antioquia
• Contact: Daniela González, Md
• Phone: 3122690961
• Email: daniela.gonzalezg[@]udea.edu.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 112
• Est. completion date: July 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic
• Pain, Postoperative
• Phantom Limb
• Phantom Limb Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Colombia	Antioquia´s University	Medellin

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Antioquia

Country where clinical trial is conducted

Colombia, 

References & Publications (3)

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. Review. — View 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. — View Citation

Gehling M, Tryba M. [Prophylaxis of phantom pain: is regional analgesia ineffective?]. Schmerz. 2003 Jan;17(1):11-9. German. — View Citation

Outcome

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