Clinical Trials Directory

Trials / Completed

CompletedNCT06001996

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
67 (actual)
Sponsor
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREPericapsular nerve group (PENG) blockPericapsular 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.
PROCEDURESuprainguinal fascia iliaca plane blockSuprainguinal 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.

Timeline

Start date
2023-10-03
Primary completion
2024-01-29
Completion
2024-01-30
First posted
2023-08-21
Last updated
2024-02-06

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06001996. Inclusion in this directory is not an endorsement.