Comparison of Intraoperative- Postoperative Effects of Pericapsular Nerve Block and Fascia Iliaca Block in Hip Fracture

NCT06001996 | Completed

• 1 other identifier: 12.09.2022/265
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to apply pericapsular nerve group (PENG) block or fascia iliaca plan block using ultrasonography to patients who will undergo hip fracture surgery, while giving sitting position before spinal anaesthesia and to reduce postoperative pain complaints. Thanks to these blocks, it is aimed to reduce pain complaints and the need for morphine-derived painkillers before and after surgery.

Conditions

Hip Fracture

Outcome Measures

Primary Outcomes (2)

• Assessment of pain level

  Assessment of pain level with the Numerical Rating Scale (NRS) : The 11-point numerical scale ranges from '0' representing one pain end (e.g. "no pain") to '10' representing the other pain end (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

  1: measured in neutral position before the block. 2: measured with 15 degrees elevation of the affected limb before the block.3: Measured in spinal positioning. 4: Measured between 0-2 hours postoperatively. 5: Measured between 2-8 hours postoperatively

• Evaluation of ease of positioning

  It was determined by means of a scale scored from 0-3 (0=no positioning, 1=standing in abnormal posture due to pain and needing support for positioning 2=mild discomfort but no need for support for positioning 3=able to position on their own without pain).

  Procedure (at the stage of introduction of spinal anaesthesia)

Secondary Outcomes (8)

• Agitation assessment

  During positioning for spinal anaesthesia procedure

• mean blood pressure

  Intraoperative (1- Baseline 2- During spinal block 3- 5th minutes after spinal block 4- Every 10 minutes during the operation 5- Skin closure)

• Heart rate

  Intraoperative (1- Baseline 2- During spinal block 3- 5th minutes after spinal block 4- Every 10 minutes during the operation 5- Skin closure)

• Tramadol consumption after surgery

  24 hours postoperatively

• Time of first analgesia use

  up to 24 hours (Duration of the first analgesic requirement after surgery (in hours))

Study Arms (2)

Pericapsular nerve group (PENG) block

Group 1:Pericapsular nerve group (PENG) block: Using an in-plane approach with ultrasonographic imaging, the block needle reaches the fascial plane between the psoas muscle and the upper pubic ramus, and patients injected with local anesthetic solution. * After the patients were sedated with intravenous 1 mg midazolam and 50 mcg fentanyl in the preoperative preparation room, 15 ml of 0.375% bupivacaine was administered to the fractured hip side under ultrasound guidance. * After the block application, the patient will be taken to the operating room and standard spinale anaesthesia will be applied. * Each patient will receive 15 ml of 0.375% bupivacaine 0.375% on the side of the broken hip only one time approximately 15-20 minutes before the operation. * Plane block applications will be applied only once in the preoperative period * Plane block applications will be performed by anaesthesiologists with at least 5 years of experience

Procedure: Pericapsular nerve group (PENG) block

Suprainguinal fascia iliaca plane block

Group 2: Suprainguinal fascia iliaca plane block: Patients in whom the needle entered in plane from the caudal end of the ultrasound probe passes through the musculus iliacus and fascia iliaca and local anesthetic solution has been injected immediately under the fascia. After the patients were sedated with intravenous 1 mg midazolam and 50 mcg fentanyl in the preoperative preparation room, 15 ml of 0.375% bupivacaine was administered to the fractured hip side under ultrasound guidance. After the block application, the patient will be taken to the operating room and standard spinale anaesthesia will be applied. Each patient will receive 15 ml of 0.375% bupivacaine 0.375% on the side of the broken hip only one time approximately 15-20 minutes before the operation. * Plane block applications will be applied only once in the preoperative period * plane block applications will be performed by anaesthesiologists with at least 5 years of experience

Procedure: Suprainguinal fascia iliaca plane block

Interventions

Pericapsular nerve group (PENG) block PROCEDURE

Pericapsular nerve group (PENG) block: Using an in-plane approach with ultrasonographic imaging, the block needle reaches the fascial plane between the psoas muscle and the superior pubic ramus and local anaesthetic solution is injected.

Pericapsular nerve group (PENG) block

Suprainguinal fascia iliaca plane block PROCEDURE

Suprainguinal fascia iliaca plane block: The needle entering in plane from the caudal end of the ultrasound probe passes through the m. sartorius and into the musculus iliacus and fascia iliaca reaches. The fascia iliaca is passed with the needle and local anaesthetic solution is injected immediately under the fascia.

Suprainguinal fascia iliaca plane block

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hip fracture

You may qualify if:

• Patients between 18-70 years of age,
• American Society of Anesthesiologists (ASA) Classification I-III,
• scheduled for hip fracture surgery under spinal anaesthesia

You may not qualify if:

• American Society of Anesthesiologists (ASA) Classification \>III
• known allergy to local anaesthetics
• presence of preoperative chronic pain
• presence of coagulopathy
• those who are unable to give written consent

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: lead

Study Sites (1)

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Diyarbakır, 21070, Turkey (Türkiye)

Location

Related Publications (1)

• Choi YS, Park KK, Lee B, Nam WS, Kim DH. Pericapsular Nerve Group (PENG) Block versus Supra-Inguinal Fascia Iliaca Compartment Block for Total Hip Arthroplasty: A Randomized Clinical Trial. J Pers Med. 2022 Mar 6;12(3):408. doi: 10.3390/jpm12030408.

  PMID: 35330408 BACKGROUND

MeSH Terms

Conditions

Hip Fractures

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Cem K. Kaçar, Assoc.Prof

  Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 21, 2023
• Study Start: October 3, 2023
• Primary Completion: January 29, 2024
• Study Completion: January 30, 2024
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

TU (1)