Clinical trial NCT06001996: Comparison of Intraoperative- Postoperative Effects of Pericapsular Nerve Block and Fascia Iliaca Block in Hip Fracture
Official title: The Effects of Pericapsular Nerve Group (PENG) Block and Fascia Iliaca Plane Block on Preoperative and Postoperative Analgesia Before Spinal Anaesthesia in Patients Undergoing Hip Fracture Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fracture
Lead sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hip fracture

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.

Detailed description: 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 superior pubic ramus and local anaesthetic solution is injected.

* Each patient will receive 15 ml of 0.375% bupivacaine on the side of the broken hip only one time approximately 15-20 minutes before the operation.
* 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.
* plane block applications will be performed by anaesthesiologists with at least 5 years of experience
* Postoperative evaluations of patients will be performed face to face.
* Plane block applications will be applied only once in the preoperative period.
* Patients will be routinely administered 1 g paracetamol intravenously at 8 hour intervals in the postoperative period. 100 mg tramadol intravenously will be administered if their pain is above Numerical Rating Scale (NRS) 4 despite this.
* This study was followed up in the orthopaedic service
* Patients will be monitored for pain and side effects at the postanesthetic care unit , 1st hour, 2nd hour, 4th hour, 8th hour and 24th hour in the postoperative period.
* The extent to which plan blocks facilitate the positioning of the patient for spinal anaesthesia in the intraoperative period will be monitored. In addition, the effects on intraoperative and postoperative opioid consumption and patient satisfaction will be observed.
* Data on the observed parameters will be obtained from face-to-face questionnaires or anesthesia and nurse observation forms.

Group 2: 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.

* Each patient will receive 15 ml of 0.375% bupivacaine on the side of the broken hip only one time approximately 15-20 minutes before the operation.
* 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.
* plane block applications will be performed by anaesthesiologists with at least 5 years of experience
* Postoperative evaluations of patients will be performed face to face.
* Plane block applications will be applied only once in the preoperative period.
* Patients will be routinely administered 1 g paracetamol intravenously at 8 hour intervals in the postoperative period. 100 mg tramadol intravenously will be administered if their pain is above Numerical Rating Scale (NRS) 4 despite this.
* This study was followed up in the orthopaedic service.
* Patients will be monitored for pain and side effects at the postanesthetic care unit , 1st hour, 2nd hour, 4th hour, 8th hour and 24th hour in the postoperative period.
* The extent to which plan blocks facilitate the positioning of the patient for spinal anaesthesia in the intraoperative period will be monitored. In addition, the effects on intraoperative and postoperative opioid consumption and patient satisfaction will be observed.
* Data on the observed parameters will be obtained from face-to-face questionnaires or anesthesia and nurse observation forms.
* Statistical methods / analysis: G-Power version 3.1.9.4 (University Kiel, Germany) program was used to calculate the sample size. The two-tailed alpha error was taken as 0.05, power as 0.80 and effect size as 0.8, and based on a previous study the allocation ratio was accepted as N2/N1:1. The minimum number of patients to be included in the study was calculated as 52.

SPSS 16.0 for Windows (SPSS Inc., Chicago, USA) was used for other statistical analyses. Statistical data were expressed as mean and standard deviation, while categorical data were expressed as frequency and percentage. Comparison of categorical data in the groups was done with Chi-square, the results were given as %n. Shapiro-Wilk tests were used to determine if the numerical data fit the normal distribution. While the data fitting the normal distribution were evaluated with the Student's t-test. Mann- Whitney U tests were used to compare the data differ from the normal distribution. p \<0.05 was considered statistically significant.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Assessment of pain level
timeFrame: 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
measure: Evaluation of ease of positioning
timeFrame: Procedure (at the stage of introduction of spinal anaesthesia)
Secondary outcomes:
measure: Agitation assessment
timeFrame: During positioning for spinal anaesthesia procedure
measure: mean blood pressure
timeFrame: Intraoperative (1- Baseline 2- During spinal block 3- 5th minutes after spinal block 4- Every 10 minutes during the operation 5- Skin closure)
measure: Heart rate
timeFrame: Intraoperative (1- Baseline 2- During spinal block 3- 5th minutes after spinal block 4- Every 10 minutes during the operation 5- Skin closure)
measure: Tramadol consumption after surgery
timeFrame: 24 hours postoperatively
measure: Time of first analgesia use
timeFrame: up to 24 hours (Duration of the first analgesic requirement after surgery (in hours))
measure: Limb range of motion
timeFrame: 1- Postoperative 4th hours , 2- Postoperative 8th hours
measure: Patient satisfaction score
timeFrame: Second postoperative day
measure: Number of Participants with Side effects
timeFrame: within 24 hours postoperatively
Other outcomes:
Locations:
city: Diyarbakır
country: Turkey
facility: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Study officials:
affiliation: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
name: Cem K. Kaçar, Assoc.Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.