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

NCT05819879 | Unknown

• 1 other identifier: AP2102-30101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoral Nerve Block; Amputation of Knee

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

PENG group

ACTIVE COMPARATOR

Procedure: peri capsular nerve group block

scaitico femoral block group

ACTIVE COMPARATOR

Procedure: scaitico femoral block

Interventions

peri capsular nerve group block 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.

PENG group

scaitico femoral block 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

scaitico femoral block group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

Ahmed Ibrahim Hussien Hussien

Cairo, 11511, Egypt

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesia, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: April 19, 2023
• Study Start: June 10, 2023
• Primary Completion: September 20, 2023
• Study Completion: September 20, 2023
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year

Locations

EG (1)