Clinical trial NCT06183541: Effects of Pericapsular Nerve Group Block Applied in Patients Undergoing Hip Fracture Surgery.
Official title: Effects of Pericapsular Nerve Group (PENG) Block Applied for Analgesia on the Postoperative Process in Patients Undergoing Hip Fracture Surgery.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Fractures
Pain, Postoperative
Keywords: PENG block
Anesthesia
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-12-27
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This prospective randomised controlled study included a total of 70 patients aged 30-85 years who underwent hip fracture surgery under spinal anaesthesia. Patients were divided into two groups as PENG block and non-PENG block (control group).
Primary purpose: TREATMENT

Brief summary: In this study, it was aimed to compare the multimodal analgesia application or the pericapsular nerve group (PENG) block methods in patients undergoing hip surgery. The effectiveness and benefit rate of the PENG block in postoperative pain will be evaluated.

Postoperative pain, need for additional analgesia, range of motion of the hip joint, mobilization time, length of hospital time and adverse events in patients undergoing hip fracture surgery with and without PENG block will be investigated.

Detailed description: This prospective randomised controlled study included a total of 70 patients aged 30-85 years who underwent hip fracture surgery under spinal anaesthesia. Patients were randomly divided into two groups using the sealed envelope method, Group I: those who received PENG block (n:35) and Group II:Those who did not receive PENG block (control group) (n: 35).

All patients will undergo hip fracture surgery by the same surgical team. Each patient will be informed about the procedure to be performed during anesthesia and surgery, and signed informed consent will be obtained before the procedure.Patients in Group I who will undergo the PENG block method; Before surgery, after spinal anesthesia, PENG block is performed under sterile conditions under ultrasonography guidance. With the patient supine, a 2-5 MHz, low-frequency, curvilinear probe is placed in the transverse plane medial to the anterior inferior iliac spine (AIIS), with the medial end of the probe rotated approximately 45° counterclockwise to align with the superior pubic ramus.

With the PENG block, an 80 mm block needle is placed in the fascial plane between the psoas tendon and the pubic ramus and 20 ml of 0.5% bupivacaine is administered.

As for the patients in Group II (control group); It is a routine practice at the end of surgery; 10 ml 0.5% bupivacaine + 10 ml 2% lidocaine is infiltrated into the surgical area by the surgical team.

For routine postoperative multimodal analgesia, intravenous PCA (patient controlled analgesia) was administered to patients in both groups with tramadol 50 mg at a basal rate of 10 mg / hour after loading (20 mg bolus dose + 30 minutes lock time) and paracetamol 10 mg / kg iv. (Given every 8 hours)

Eligibility criteria: Inclusion Criteria:

* Patients who will undergo hip fracture surgery Women and men aged 30-85

Exclusion Criteria:

* Patients under 30 years old, over 85 years old
* American Society of Anesthesiology (ASA) IV,
* Those with cognitive impairment (alzheimer, dementia, delirium, etc.)
* Those with application site infection
* Those who are allergic to local anesthetic substances
* Patients are non-consenting patients.

Primary outcomes:
measure: postoperative pain score
timeFrame: 30 min, 12th, 24th and 48th hours in the postoperative period
measure: Total opioid consumption
timeFrame: postoperative 48 hours
measure: mobilisation time
timeFrame: postoperative 24-48 hours
Secondary outcomes:
measure: PENG block adverse events
timeFrame: between the time surgery starts and the 48th hour
measure: length of hospital stay
timeFrame: between the time of hospitalization for the operation and discharge (day)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Umraniye Education and Research Hospital
state: Umraniye
city: Istanbul
country: Turkey
facility: UmraniyeERH
state: Umraniye
Study officials:
affiliation: Umraniye Education and Research Hospita
name: Zeliha Tuncel, MD
role: STUDY_DIRECTOR
References: