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NCT04564326 Clinical Trial

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

Hip Fractures Clinical Trial

Official title:
Pericapsular Nerve Group Block Versus Fascia Iliaca Block for Pre- and Post-Operative Analgesia in Elderly Patients With Hip Fracture

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04564326
Other study ID # 6228/20-7-2020
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date September 1, 2022

Study information
Verified date September 2020
Source Zagazig University
Contact khaled M Mohamed, Master degree
Phone 00201007575373
Email dr_k3@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 51
Est. completion date September 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Zagazig University

References & Publications (19)

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. Erratum in: J Pain. 2016 Apr;17(4):508-10. Dosage error in article text. — View Citation

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

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. — View Citation

Girón-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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Langley GB, Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int. 1985;5(4):145-8. — View Citation

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. — View Citation

Morrison RS, 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):303-11. — View Citation

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. — View Citation

Parker M, Johansen A. Hip fracture. BMJ. 2006 Jul 1;333(7557):27-30. Review. — View Citation

Pasero C. Fentanyl for acute pain management. J Perianesth Nurs. 2005 Aug;20(4):279-84. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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