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

NCT ID: NCT05819879

Last Updated: 2023-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-10
• Study Completion Date: 2023-09-20

Brief Summary

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.

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.

Conditions

Femoral Nerve Block; Amputation of Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PENG group

Group Type: ACTIVE_COMPARATOR

peri capsular nerve group block

Intervention Type: PROCEDURE

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.

scaitico femoral block group

Group Type: ACTIVE_COMPARATOR

scaitico femoral block

Intervention Type: PROCEDURE

. 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

Interventions

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.

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Ibrahim Hussien Hussien

Resident of Anesthesia, Surgical Intensive Care and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ahmed Ibrahim Hussien Hussien

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Ahmed I Hussien, MD

Role: primary

Ahmedtito1590@gmail.com

01111929423 ext. 02

Other Identifiers

AP2102-30101

Identifier Type: -

Identifier Source: org_study_id