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

Hip Fracture Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06001996
• Other study ID #: 12.09.2022/265
• Status: Completed
• Start date: October 3, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: February 2024
• Source: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: January 30, 2024
• Est. primary completion date: January 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Procedure:
• Pericapsular nerve group (PENG) block
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.
• Suprainguinal fascia iliaca plane block
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.

Locations

Country	Name	City	State
Turkey	Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital	Diyarbakir

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Agitation assessment	Agitation assessment with Richmond Agitation Sedation Scale (RASS) is a 10-point scale ranging from -5 to +4.Levels -1 to -5 denote 5 levels of sedation, starting with "awakens to voice" and ending with "unarousable." Levels +1 to +4 describe increasing levels of agitation. The lowest level of agitation starts with apprehension and anxiety, and peaks at combative and violent. RASS level 0 is "alert and calm.	During positioning for spinal anaesthesia procedure
Secondary	mean blood pressure	Mean blood pressure assessed using automatic sphygmomanometer over a 60 second interval	Intraoperative (1- Baseline 2- During spinal block 3- 5th minutes after spinal block 4- Every 10 minutes during the operation 5- Skin closure)
Secondary	Heart rate	The number of heart beats per minute obtained by electrocardiographic monitoring	Intraoperative (1- Baseline 2- During spinal block 3- 5th minutes after spinal block 4- Every 10 minutes during the operation 5- Skin closure)
Secondary	Tramadol consumption after surgery	Total amount of tramadol consumed within 24 hours after surgery	24 hours postoperatively
Secondary	Time of first analgesia use	Duration of the first analgesic requirement after surgery (in hours)	up to 24 hours (Duration of the first analgesic requirement after surgery (in hours))
Secondary	Limb range of motion	Limb range of motion assessed using goniometer	1- Postoperative 4th hours , 2- Postoperative 8th hours
Secondary	Patient satisfaction score	Patients' satisfaction with the quality of pain management will be assessed on the second postoperative day using the following scale: 1 = very unsatisfied; 2 = quite unsatisfied; 3 = moderate; 4 = quite satisfactory; 5 = very satisfactory.	Second postoperative day
Secondary	Number of Participants with Side effects	Number of Participants with side effects such as neurological deficit, oedema, haematoma, nausea and vomiting will be evaluated by physical examination, patient anamnesis and nurse follow-up forms	within 24 hours postoperatively