Femoral Nerve BlockNCT05819879
PENG Block vs Sciatico Femoral Block in the Incidence of Post Amputation Syndroms
A study testing peri capsular nerve group block and scaitico femoral block in people with Femoral Nerve Block and Amputation of Knee, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Femoral Nerve Block, Amputation of Knee
- What is being tested?
- peri capsular nerve group block and scaitico femoral block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2023to 20 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA class I and II
- Age above 20 and less than 60 years.
- Patients undergoing above knee amputation due to any type of cancer
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Ibrahim Hussien Hussien
Cairo, 11511
Ahmed I Hussien, MD, 01111929423 ext. 02, Ahmedtito1590@gmail.com
About this study
Official title: 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.
Read the 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
- Being tested
- peri capsular nerve group block, scaitico femoral block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peri capsular nerve group blockProcedure or surgery
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 blockProcedure or surgery
. 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
| Study group | Role | What they receive |
|---|---|---|
| PENG group | Active comparator | Not described Receives: Procedure: peri capsular nerve group block |
| scaitico femoral block group | Active comparator | Not described Receives: Procedure: scaitico femoral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start10 Jun 2023
- Primary completion20 Sep 2023 (estimated)
- Study completion20 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Nerve BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ibrahim Hussien Hussien, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819879
- Sponsor's protocol ID
- AP2102-30101
- Status last verified
- Jul 2023
- First submitted
- 7 Mar 2023
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri Capsular Nerve Group Block Versus Sciatico Femoral Block to Assess the Incidence of Post Amputation Syndroms in Patients Undergoing Above Knee Amputation Surgeries
- ClinicalTrials.gov ID
- NCT05819879
- Acronym / sponsor ID
- AP2102-30101
- Conditions
- Femoral Nerve Block, Amputation of Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 20 Sep 2023 (estimated)
- Study completion
- 20 Sep 2023 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENG group | Active comparator | Procedure: peri capsular nerve group block |
| scaitico femoral block group | Active comparator | Procedure: scaitico femoral block |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA class I and II
- Age above 20 and less than 60 years.
- Patients undergoing above knee amputation due to any type of cancer
Key exclusion criteria (8 listed)
- Patient refusal.
- Local infection at the puncture site.
- Coagulopathy.
- Cognitive disorders.
- Unstable cardiovascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peri capsular nerve group blockThe 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. | Procedure or surgery | PENG group |
| 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 | Procedure or surgery | scaitico femoral block group |
Primary outcome
Incidence of the efficacy of peri capsular nerve group block
Time frame: 24 hours postoperatively
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from the principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peri capsular nerve group block and scaitico femoral block in people with Femoral Nerve Block and Amputation of Knee, run by National Cancer Institute, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of the efficacy of peri capsular nerve group block (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.