PENG Block Versus Fascia Iliaca Block for Pre- and Post-Operative Analgesia in Elderly Patients With Hip Fracture
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| ClinicalTrials.gov Identifier: NCT04564326 |
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Recruitment Status :
Not yet recruiting
First Posted : September 25, 2020
Last Update Posted : September 30, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hip Fractures | Procedure: Pericapsular nerve Group block Procedure: Facia Iliaca block Drug: Fentanyl | Not Applicable |
Pain is a major problem that has to be dealt with in case of hip fracture, as it resembles an obstacle for examination, positioning for receiving neuroaxial anesthesia and postoperative mobility and physiotherapy.
With the introduction of ultrasound in regional anesthesia and peripheral nerve blocks, regional analgesia float to the surface as a substitute for opioids with less side effects. Of the many techniques to provide regional analgesia for hip fractures; fascia iliaca block was widely used with good results. In 2018 Pericapsular Nerve Group Block was introduced to provide regional analgesia for hip fractures with interesting results.
In this study the investigators are going to compare Pericapsular Nerve Group Block and Fascia Iliaca Block to find the best way to provide analgesia for elderly patients with hip fracture in the pre- and post-operative periods.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 51 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Supportive Care |
| Official Title: | Pericapsular Nerve Group Block Versus Fascia Iliaca Block for Pre- and Post-Operative Analgesia in Elderly Patients With Hip Fracture |
| Estimated Study Start Date : | January 1, 2021 |
| Estimated Primary Completion Date : | March 1, 2022 |
| Estimated Study Completion Date : | September 1, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Group C
Patients will be assigned to receive opioids analgesia before spinal anesthesia in the form of intravenous fentanyl in a dose of 1mic/kg divided into two boluses with 5 minutes interval in between before positioning the patient for spinal anesthesia.
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Drug: Fentanyl
Intravenous fentanyl in a dose of 1mic/kg divided into two boluses with 5 minutes interval in between.
Other Name: Intravenous opioid |
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Experimental: Group P
Patients will be assigned to receive Pericapsular Nerve Group Block (PENG Block) before positioning the patient for spinal anesthesia.
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Procedure: Pericapsular nerve Group block
Under ultrasound guidance a needle is inserted between the iliopectineal eminence and the iliopsoas muscle and tendon to block articular branches supplying the capsule of hip joint.
Other Name: PENG block |
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Experimental: Group F
Patients will be assigned to receive Fascia Iliaca Block (F.I Block) before positioning for spinal anesthesia.
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Procedure: Facia Iliaca block
Under ultrasound guidance a needle is inserted between the fascia iliaca and Psoas muscle to block the femoral, obturator and lateral cutaneous nerves.
Other Name: FI block |
- Comparison between the analgesic effect of both Pericapsular Nerve Group block and Fascia Iliaca block with VAS score. [ Time Frame: Baseline ]Analysis of Visual Analogue Pain Score for both PENG block and FI block before and after each block during rest and movement to compare between their analgesic effect. The Visual Analogue Pain score is done by drawing a 10cm vertical line on a piece of paper with its limits "no pain" (0) on one side and "extreme pain" (10) on the other side. The patient will be asked to point where the pain (he/she) experiences lies on the line.
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| Ages Eligible for Study: | 65 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient acceptance.
- Accepted mental state of the patient.
- Gender: both sexes.
- Age above 65 years old.
- Body mass index 18.5-35 kg/m2.
- ASA physical status II and III.
- Unilateral hip fracture assigned for surgical fixation.
- Expected duration of surgery ≤ 3 hours.
Exclusion Criteria:
- Associated trauma or multiple fractures.
- Peripheral neuropathy.
- Coagulopathy.
- Infection at site of injection.
- Allergy to the drugs used in the study.
- Advanced kidney, liver or heart disease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04564326
| Contact: khaled M Mohamed, Master degree | 00201007575373 | dr_k3@yahoo.com |
| Principal Investigator: | Khaled M Mohamed, Master degree | Zagazig University |
Documents provided by Khaled Moustafa Magdy Nasr Mohamed, Zagazig University:
Publications:
| Responsible Party: | Khaled Moustafa Magdy Nasr Mohamed, Principal Investigator, Zagazig University |
| ClinicalTrials.gov Identifier: | NCT04564326 |
| Other Study ID Numbers: |
6228/20-7-2020 |
| First Posted: | September 25, 2020 Key Record Dates |
| Last Update Posted: | September 30, 2020 |
| Last Verified: | September 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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PENG block Hip fracture analgesia |
Fascia Iliaca block ultrasound Fentanyl |
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Fractures, Bone Hip Fractures Wounds and Injuries Femoral Fractures Hip Injuries Leg Injuries Fentanyl Analgesics, Opioid Narcotics |
Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Anesthetics |