PENG Block Versus Fascia Iliaca Block for Pre- and Post-Operative Analgesia in Elderly Patients With Hip Fracture

NCT ID: NCT04564326

Last Updated: 2020-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-09-01

Brief Summary

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Clinical controled trial to compare between 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.

Detailed Description

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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.

Conditions

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Hip Fractures

Keywords

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PENG block Hip fracture analgesia Fascia Iliaca block ultrasound Fentanyl

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

Intravenous fentanyl in a dose of 1mic/kg divided into two boluses with 5 minutes interval in between.

Group P

Patients will be assigned to receive Pericapsular Nerve Group Block (PENG Block) before positioning the patient for spinal anesthesia.

Group Type EXPERIMENTAL

Pericapsular nerve Group block

Intervention Type PROCEDURE

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.

Group F

Patients will be assigned to receive Fascia Iliaca Block (F.I Block) before positioning for spinal anesthesia.

Group Type EXPERIMENTAL

Facia Iliaca block

Intervention Type PROCEDURE

Under ultrasound guidance a needle is inserted between the fascia iliaca and Psoas muscle to block the femoral, obturator and lateral cutaneous nerves.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Fentanyl

Intravenous fentanyl in a dose of 1mic/kg divided into two boluses with 5 minutes interval in between.

Intervention Type DRUG

Other Intervention Names

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PENG block FI block Intravenous opioid

Eligibility Criteria

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Inclusion Criteria

1. Patient acceptance.
2. Accepted mental state of the patient.
3. Gender: both sexes.
4. Age above 65 years old.
5. Body mass index 18.5-35 kg/m2.
6. ASA physical status II and III.
7. Unilateral hip fracture assigned for surgical fixation.
8. Expected duration of surgery ≤ 3 hours.

Exclusion Criteria

1. Associated trauma or multiple fractures.
2. Peripheral neuropathy.
3. Coagulopathy.
4. Infection at site of injection.
5. Allergy to the drugs used in the study.
6. Advanced kidney, liver or heart disease.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Khaled Moustafa Magdy Nasr Mohamed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Khaled M Mohamed, Master degree

Role: PRINCIPAL_INVESTIGATOR

Zagazig University

Central Contacts

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khaled M Mohamed, Master degree

Role: CONTACT

Phone: 00201007575373

Email: [email protected]

References

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Parker M, Johansen A. Hip fracture. BMJ. 2006 Jul 1;333(7557):27-30. doi: 10.1136/bmj.333.7557.27. No abstract available.

Reference Type BACKGROUND
PMID: 16809710 (View on PubMed)

Kowark A, Rossaint R, Coburn M. General versus spinal anesthesia for the elderly hip fractured patient. Curr Opin Anaesthesiol. 2019 Feb;32(1):116-119. doi: 10.1097/ACO.0000000000000679.

Reference Type BACKGROUND
PMID: 30543554 (View on PubMed)

Neuman MD, Silber JH, Elkassabany NM, Ludwig JM, Fleisher LA. Comparative effectiveness of regional versus general anesthesia for hip fracture surgery in adults. Anesthesiology. 2012 Jul;117(1):72-92. doi: 10.1097/ALN.0b013e3182545e7c.

Reference Type BACKGROUND
PMID: 22713634 (View on PubMed)

Yun MJ, Kim YH, Han MK, Kim JH, Hwang JW, Do SH. Analgesia before a spinal block for femoral neck fracture: fascia iliaca compartment block. Acta Anaesthesiol Scand. 2009 Nov;53(10):1282-7. doi: 10.1111/j.1399-6576.2009.02052.x. Epub 2009 Jul 22.

Reference Type BACKGROUND
PMID: 19650803 (View on PubMed)

Morrison SR, Magaziner J, McLaughlin MA, Orosz G, Silberzweig SB, Koval KJ, Siu AL. The impact of post-operative pain on outcomes following hip fracture. Pain. 2003 Jun;103(3):303-311. doi: 10.1016/S0304-3959(02)00458-X.

Reference Type BACKGROUND
PMID: 12791436 (View on PubMed)

Morrison RS, Dickman E, Hwang U, Akhtar S, Ferguson T, Huang J, Jeng CL, Nelson BP, Rosenblatt MA, Silverstein JH, Strayer RJ, Torrillo TM, Todd KH. Regional Nerve Blocks Improve Pain and Functional Outcomes in Hip Fracture: A Randomized Controlled Trial. J Am Geriatr Soc. 2016 Dec;64(12):2433-2439. doi: 10.1111/jgs.14386. Epub 2016 Oct 27.

Reference Type BACKGROUND
PMID: 27787895 (View on PubMed)

Helmerhorst GT, Vranceanu AM, Vrahas M, Smith M, Ring D. Risk factors for continued opioid use one to two months after surgery for musculoskeletal trauma. J Bone Joint Surg Am. 2014 Mar 19;96(6):495-9. doi: 10.2106/JBJS.L.01406.

Reference Type BACKGROUND
PMID: 24647506 (View on PubMed)

Pasero C. Fentanyl for acute pain management. J Perianesth Nurs. 2005 Aug;20(4):279-84. doi: 10.1016/j.jopan.2005.03.007. No abstract available.

Reference Type BACKGROUND
PMID: 16102709 (View on PubMed)

Scurrah A, Shiner CT, Stevens JA, Faux SG. Regional nerve blockade for early analgesic management of elderly patients with hip fracture - a narrative review. Anaesthesia. 2018 Jun;73(6):769-783. doi: 10.1111/anae.14178. Epub 2017 Dec 26.

Reference Type BACKGROUND
PMID: 29278266 (View on PubMed)

Curatolo M. Regional anesthesia in pain management. Curr Opin Anaesthesiol. 2016 Oct;29(5):614-9. doi: 10.1097/ACO.0000000000000353.

Reference Type BACKGROUND
PMID: 27137511 (View on PubMed)

Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.

Reference Type BACKGROUND
PMID: 26827847 (View on PubMed)

Shin JJ, McCrum CL, Mauro CS, Vyas D. Pain Management After Hip Arthroscopy: Systematic Review of Randomized Controlled Trials and Cohort Studies. Am J Sports Med. 2018 Nov;46(13):3288-3298. doi: 10.1177/0363546517734518. Epub 2017 Oct 13.

Reference Type BACKGROUND
PMID: 29028436 (View on PubMed)

Haines L, Dickman E, Ayvazyan S, Pearl M, Wu S, Rosenblum D, Likourezos A. Ultrasound-guided fascia iliaca compartment block for hip fractures in the emergency department. J Emerg Med. 2012 Oct;43(4):692-7. doi: 10.1016/j.jemermed.2012.01.050. Epub 2012 Apr 9.

Reference Type BACKGROUND
PMID: 22494596 (View on PubMed)

Short AJ, Barnett JJG, Gofeld M, Baig E, Lam K, Agur AMR, Peng PWH. Anatomic Study of Innervation of the Anterior Hip Capsule: Implication for Image-Guided Intervention. Reg Anesth Pain Med. 2018 Feb;43(2):186-192. doi: 10.1097/AAP.0000000000000701.

Reference Type BACKGROUND
PMID: 29140962 (View on PubMed)

Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.

Reference Type BACKGROUND
PMID: 30063657 (View on PubMed)

Dolan J, Williams A, Murney E, Smith M, Kenny GN. Ultrasound guided fascia iliaca block: a comparison with the loss of resistance technique. Reg Anesth Pain Med. 2008 Nov-Dec;33(6):526-31. doi: 10.1016/j.rapm.2008.03.008.

Reference Type BACKGROUND
PMID: 19258967 (View on PubMed)

Langley GB, Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int. 1985;5(4):145-8. doi: 10.1007/BF00541514.

Reference Type BACKGROUND
PMID: 4048757 (View on PubMed)

Wei LA, Fearing MA, Sternberg EJ, Inouye SK. The Confusion Assessment Method: a systematic review of current usage. J Am Geriatr Soc. 2008 May;56(5):823-30. doi: 10.1111/j.1532-5415.2008.01674.x. Epub 2008 Apr 1.

Reference Type BACKGROUND
PMID: 18384586 (View on PubMed)

Ross VH, Pan PH, Owen MD, Seid MH, Harris L, Clyne B, Voltaire M, Eisenach JC. Neostigmine decreases bupivacaine use by patient-controlled epidural analgesia during labor: a randomized controlled study. Anesth Analg. 2009 Aug;109(2):524-31. doi: 10.1213/ane.0b013e31819518e4. Epub 2009 Apr 17.

Reference Type BACKGROUND
PMID: 19377050 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Related Links

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http://www.hqontario.ca/evidence/publications-and-ohtac-recommendations/clinical-handbooks

Quality-Based Procedures: Clinical Handbook for Hip Fracture.

Other Identifiers

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6228/20-7-2020

Identifier Type: -

Identifier Source: org_study_id