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

NCT04564326 | Unknown DMC

• 1 other identifier: 6228/20-7-2020
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hip Fractures

Keywords

PENG block; Hip fracture; analgesia; Fascia Iliaca block; ultrasound; Fentanyl

Outcome Measures

Primary Outcomes (1)

• Comparison between the analgesic effect of both Pericapsular Nerve Group block and Fascia Iliaca block with VAS score.

  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.

  Baseline

Study Arms (3)

Group C

ACTIVE COMPARATOR

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.

Drug: Fentanyl

Group P

EXPERIMENTAL

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

Procedure: Pericapsular nerve Group block

Group F

EXPERIMENTAL

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

Procedure: Facia Iliaca block

Interventions

Pericapsular nerve Group block 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.

Also known as: PENG block

Group P

Facia Iliaca block PROCEDURE

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

Also known as: FI block

Group F

Fentanyl DRUG

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

Also known as: Intravenous opioid

Group C

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Related Publications (19)

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

  PMID: 16809710 BACKGROUND

• 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.

  PMID: 30543554 BACKGROUND

• 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.

  PMID: 22713634 BACKGROUND

• 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.

  PMID: 19650803 BACKGROUND

• 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.

  PMID: 12791436 BACKGROUND

• 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.

  PMID: 27787895 BACKGROUND

• 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.

  PMID: 24647506 BACKGROUND

• 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.

  PMID: 16102709 BACKGROUND

• 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.

  PMID: 29278266 BACKGROUND

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

  PMID: 27137511 BACKGROUND

• 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.

  PMID: 26827847 BACKGROUND

• 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.

  PMID: 29028436 BACKGROUND

• 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.

  PMID: 22494596 BACKGROUND

• 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.

  PMID: 29140962 BACKGROUND

• 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.

  PMID: 30063657 BACKGROUND

• 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.

  PMID: 19258967 BACKGROUND

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

  PMID: 4048757 BACKGROUND

• 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.

  PMID: 18384586 BACKGROUND

• 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.

  PMID: 19377050 BACKGROUND

Related Links

• Quality-Based Procedures: Clinical Handbook for Hip Fracture.

MeSH Terms

Conditions

Hip Fractures; Agnosia

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Khaled M Mohamed, Master degree

  Zagazig University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

khaled M Mohamed, Master degree

CONTACT

00201007575373; dr_k3@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 20, 2020
• First Posted: September 25, 2020
• Study Start: January 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 30, 2020

Record last verified: 2020-09