Lateral Cutaneous Nerve and PENG Blocks Versus Suprainguinal Fascia Iliaca Block in Post-op Analgesia of Hip Fractures

NCT05749367 | Unknown DMC

• 1 other identifier: CAAE:42438721.1.0000.5129
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain in hip fractures is challenging and requires adequate management. Peripheral nerve blocks are already known as superior than systemic analgesia in this scenario, but the best analgesic regional technique is still unknown. The investigators propose a study to compare the postoperative analgesia of hip fractures between pericapsular nerve group block plus lateral femoral cutaneous nerve block and suprainguinal fascia iliaca block

Conditions

Anesthesia, Conduction

Outcome Measures

Primary Outcomes (3)

• Dynamic Post-op Hip Pain

  To assess dynamic hip pain (passive leg elevation at 15°) in postoperative period using the Numeric Rating Scale (0-10), on which patients rate their current pain intensity from (no pain) to 10 (worst possible pain).

  6 hours after spinal anesthesia.

• Dynamic Post-op Hip Pain

  To assess dynamic hip pain (passive leg elevation at 15°) in postoperative period using the Numeric Rating Scale (0-10), on which patients rate their current pain intensity from (no pain) to 10 (worst possible pain).

  12 hours after spinal anesthesia

• Dynamic Post-op Hip Pain

  To assess dynamic hip pain (passive leg elevation at 15°) in postoperative period using the Numeric Rating Scale (0-10), on which patients rate their current pain intensity from (no pain) to 10 (worst possible pain).

  24 hours after spinal anesthesia

Secondary Outcomes (8)

• Post-op Hip Pain at Rest

  6 hours, 12 hours and 24 hours after spinal anesthesia.

• Quadriceps muscle strength measured by dynamometry in newton (N).

  6 hours, 12 hours and 24 hours after spinal anesthesia.

• Quadriceps muscle strength index

  6 hours, 12 hours and 24 hours after spinal anesthesia.

• Total intravenous morphine dose in milligram over 24 hours

  24 hours

• Time of the first morphine order in minutes

  24 hours

Study Arms (2)

Suprainguinal Fascia Iliaca Block Group

ACTIVE COMPARATOR

Patients will undergo SIFIB with ropivacaine and PENG plus LFCNB with saline solution.

Drug: Ropivacaine + saline solution

PENG Block + Lateral Femoral Cutaneous Nerve Block Group

EXPERIMENTAL

Patients will undergo SIFIB with saline solution and PENG plus LFCNB ropivacaine.

Drug: Saline solution + Ropivacaine

Interventions

Ropivacaine + saline solution DRUG

SIFIB with 30 ml of 0.5% ropivacaine and PENG Block plus LFCNB with 20 ml and 10 ml of saline solution, respectively.

Also known as: Naropin + saline solution

Suprainguinal Fascia Iliaca Block Group

Saline solution + Ropivacaine DRUG

SIFIB with 30 ml of saline solution and PENG Block plus LFCNB with 20 ml and 10 ml of 0,5% ropivacaine, respectively.

Also known as: Saline solution + Naropin

PENG Block + Lateral Femoral Cutaneous Nerve Block Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with hip fractures who will undergo surgical treatment.
• Adults over 18 years.
• American Society of Anesthesiology physical status 1 to 3.
• Body mass index (BMI) \< 35 Kg/m2.

You may not qualify if:

• Local anesthetic allergy
• Coagulopathy
• American Society of Anesthesiology physical status ≥ 4,
• Dementia
• Peripheral polyneuropathy
• Pregnancy
• Chronic opioid use (\> 3 months)
• BMI \>35 Kg/m2
• Stroke with lower limb motor sequelae
• Patient refusal/withdrawal
• Those whose spinal anesthesia has been changed to general anesthesia.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Hospital Odilon Behrens

Belo Horizonte, Minas Gerais, 31.110-430, Brazil

Location

Related Publications (9)

• 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

• Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.

  PMID: 33238043 BACKGROUND

• Bugada D, Bellini V, Lorini LF, Mariano ER. Update on Selective Regional Analgesia for Hip Surgery Patients. Anesthesiol Clin. 2018 Sep;36(3):403-415. doi: 10.1016/j.anclin.2018.04.001. Epub 2018 Jul 11.

  PMID: 30092937 BACKGROUND

• Vermeylen K, Desmet M, Leunen I, Soetens F, Neyrinck A, Carens D, Caerts B, Seynaeve P, Hadzic A, Van de Velde M. Supra-inguinal injection for fascia iliaca compartment block results in more consistent spread towards the lumbar plexus than an infra-inguinal injection: a volunteer study. Reg Anesth Pain Med. 2019 Feb 22:rapm-2018-100092. doi: 10.1136/rapm-2018-100092. Online ahead of print.

  PMID: 30798268 BACKGROUND

• Desmet M, Vermeylen K, Van Herreweghe I, Carlier L, Soetens F, Lambrecht S, Croes K, Pottel H, Van de Velde M. A Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty. Reg Anesth Pain Med. 2017 May/Jun;42(3):327-333. doi: 10.1097/AAP.0000000000000543.

  PMID: 28059869 BACKGROUND

• Morrison C, Brown B, Lin DY, Jaarsma R, Kroon H. Analgesia and anesthesia using the pericapsular nerve group block in hip surgery and hip fracture: a scoping review. Reg Anesth Pain Med. 2021 Feb;46(2):169-175. doi: 10.1136/rapm-2020-101826. Epub 2020 Oct 27.

  PMID: 33109730 BACKGROUND

• Aliste J, Layera S, Bravo D, Jara A, Munoz G, Barrientos C, Wulf R, Branez J, Finlayson RJ, Tran Q. Randomized comparison between pericapsular nerve group (PENG) block and suprainguinal fascia iliaca block for total hip arthroplasty. Reg Anesth Pain Med. 2021 Oct;46(10):874-878. doi: 10.1136/rapm-2021-102997. Epub 2021 Jul 20.

  PMID: 34290085 BACKGROUND

• Lin DY, Morrison C, Brown B, Saies AA, Pawar R, Vermeulen M, Anderson SR, Lee TS, Doornberg J, Kroon HM, Jaarsma RL. Pericapsular nerve group (PENG) block provides improved short-term analgesia compared with the femoral nerve block in hip fracture surgery: a single-center double-blinded randomized comparative trial. Reg Anesth Pain Med. 2021 May;46(5):398-403. doi: 10.1136/rapm-2020-102315. Epub 2021 Feb 26.

  PMID: 33637625 BACKGROUND

• Macedo MC, Souza MA, Ferreira KR, Campos LO, Souza ISO, Barbosa MA, Brito CJ, Intelangelo L, Barbosa AC. Validity and Test-Retest Reliability of a Novel Push Low-Cost Hand-Held Dynamometer for Knee Strength Assessment during Different Force Ranges. Diagnostics (Basel). 2022 Jan 13;12(1):186. doi: 10.3390/diagnostics12010186.

  PMID: 35054353 BACKGROUND

MeSH Terms

Interventions

Ropivacaine; Saline Solution

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Leonardo SG Oliveira, MD

  Hospital Municipal Odilon Behrens - Belo Horizonte/Brazil and Universidade Federal de Minas Gerais

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonardo SG Oliveira, MD

CONTACT

55 31988870672; saraivaleo@gmail.com

Renato S Gomez, Ph.D

CONTACT

55 31988619475; renatogomez2000@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In the control group, patients will undergo SIFIB with ropivacaine and to maintain the masking they will also undergo PENG and LFCNB with saline solution (sham block). In the experimental group, patients will receive ropivacaine in the PENG block associated with LFCNB and saline solution in the SIFIB. All the work of randomization, editing of the spreadsheet, manipulation of the envelopes, as well as the confidential tabulation of the data during collection will be done by an assistant who will not participate in the anesthesia or data collection. The opening of the envelopes and the preparation of the material for anesthesia will also be done by an assistant who will not participate in the evaluation of the outcomes. The researcher will perform all the procedures and data collection and will not know which group the participant belongs to. The patient will also not know in which group he or she is allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery Department at Medical School of Universidade Federal de Minas Gerais. Ph.D

Model Details: Prospective, controlled, randomized and double blind

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 1, 2023
• Study Start: March 6, 2023
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)