PENG Block vs Sciatico Femoral Block in the Incidence of Post Amputation Syndroms

Peri Capsular Nerve Group Block Versus Sciatico Femoral Block to Assess the Incidence of Post Amputation Syndroms in Patients Undergoing Above Knee Amputation Surgeries

assess the effectiveness of peri-capsular nerve group block and scaitico femoral block in the incidence of post amputation syndrome in patients undergoing above knee amputation.

Study Overview

• Status: Recruiting
• Conditions: Femoral Nerve Block; Amputation of Knee
• Intervention / Treatment: Procedure: peri capsular nerve group block; Procedure: scaitico femoral block

Detailed Description

The loss of a body part can lead to pain and other sensations that fall into three distinct descriptive categories, namely phantom sensations, phantom pain, and residual pain. Phantom sensations are defined as pain-free perceptions emanating from the lost body part after deafferentation, and phantom pain is a painful or unpleasant sensation in the distribution of the lost or deafferented body part 5. Phantom sensations can be a different expression of phantom pain and interfere with rehabilitation therapy by enhancing and interacting with phantom pain.

The current standard of care is pre-operative nerve blockade to prevent peripheral sensitization leading to future onset of phantom limb pain. Successful outcomes necessitate effective communication between the surgeon, anesthesiologist, and the various teams involved in the post-operative rehabilitation of the patient. A consultation with the Acute Pain Service or similar entity that performs peripheral nerve blockade pre-operatively and then follows the patient during their post-operative inpatient course is an important factor in the success in early prevention of acute and chronic pain for these patients.

Pericapsular nerve group block or PENG block is a novel regional nerve block to provide analgesia in fractured hip patients. It is primarily an ultrasound-guided (USG) technique where target area is the pelvic rim (superior pubic ramus) near iliopectineal eminence, deep to fascia of iliopsoas muscle. Articular branches of femoral nerve and accessory obturator nerves, which cross over the bony rim, are primary targets of the PENG block.however, by increasing volume of local anesthetic drug; other nerves (obturator, femoral, genitofemoral, and lateral femoral cutaneous nerve) can be blocked.

This block is a new regional anesthesia technique based on blocking the femoral nerve (FN) and accessory obturator nerve (ON) with a single injection.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11511
    • Recruiting
    • Ahmed Ibrahim Hussien Hussien
    • Contact: Ahmed I Hussien, MD; Phone Number: 02 01111929423; Email: Ahmedtito1590@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ASA class I and II
• Age above 20 and less than 60 years.
• Patients undergoing above knee amputation due to any type of cancer

Exclusion Criteria:

• Patient refusal.
• Local infection at the puncture site.
• Coagulopathy.
• Cognitive disorders.
• Unstable cardiovascular disease.
• History of psychiatric disorders.
• History of drug abuse.
• Patients allergic to medication used.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PENG group	Procedure: peri capsular nerve group block; The block will be administered under ultrasound guidance with low frequency curvilinear probe. The probe will be placed parallel to the inguinal crease, at the level of anterior superior iliac spine. The scanning will be done with gradual caudad movement of the probe. After the anterior inferior iliac spine (AIIS) become visible, the probe will be turned slightly medial until the hyperechoic continuous shadow of superior pubic ramus become visible. The psoas muscle with prominent tendon will be identified just above the pubic ramus. The target is the plane between these two structures. Aligning the pubic ramus in the center of the image and targeting the pubic ramus just medial to the AIIS, a standard 25G Quincke needle will be introduced and 20 mL 0.125% bupivacaine with 4 mg dexamethasone was administered using ultrasound-guided out-of-plane technique.
Active Comparator: scaitico femoral block group	Procedure: scaitico femoral block; . After draping the left inguinal region, the femoral nerve will be identified lateral to the femoral artery using a 5- to 13-MHz linear phased array transducer ). Under ultrasound guidance, a 25G Quincke needle will be introduced toward the femoral nerve parallel to the ultrasound beam, and 20 mL of a local anesthetic mixture 20 mL 0.125% bupivacaine with 4 mg dexamethasone will be injected. The trajectory of the needle was adjusted to achieve even distribution of the local anesthetics around the femoral nerve. Then, the patient will be placed in the right lateral position with the left hip and knee joints flexed by 30° to 50°. Following the identification of the left sciatic nerve located in the intermuscular plane of the gluteus maximus and medius muscles between the ipsilateral ischial tuberosity and greater trochanter using a convex phased array transducer 20 mL 0.125% bupivacaine with 4 mg dexamethasone will be placed near the sciatic nerve through the 22-ga Tuohy needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of the efficacy of peri capsular nerve group block	Incidence of the efficacy of peri capsular nerve group block in reducing the post amputation limb pain for 24h and to compare it with the efficacy of scaitico femoral nerve block in reducing the post amputation limb pain as well.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: National Cancer Institute, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2023
• Primary Completion (Estimated): September 20, 2023
• Study Completion (Estimated): September 20, 2023

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: AP2102-30101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon reasonable request from the principal investigator
• IPD Sharing Time Frame: One year
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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