Clinical trial NCT06183528: Effects of Pericapsular Nerve Group Block on Postoperative Recovery for Total Hip Arthroplasty
Official title: Effects of Pericapsular Nerve Group Block on Postoperative Recovery for Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Analgesia
Postoperative Pain, Acute
Keywords: Multimodal analgesia
pericapsular nerve group block
total hip arthroplasty
spinal anesthesia
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-12-27
Enrollment: 60
Sex: ALL
Minimum age (years): 40
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 60 patients aged 40-85 years who underwent THA surgery under spinal anaesthesia. Patients were divided into two groups as PENG block and non-PENG block (control group).
Primary purpose: TREATMENT

Brief summary: The hypothesis of this study is that patients who undergo PENG block in before Total Hip Artroplasthy (THA) surgery with spinal anesthesia will have reduced postoperative pain scores, less need for opioid analgesics and earlier mobilisation.

Detailed description: This prospective randomised controlled study included a total of 60 patients aged 40-85 years who underwent THA surgery under spinal anaesthesia. Patients were divided into two groups as PENG block (n:30) and non-PENG block (n:30). PENG block was placed in the fascial plane between the pseudotendon and pubic ramus with USG in-plane technique, 20 ml of 0.5% bupivacaine was administered and surgery was initiated. The primary outcome of the study was to investigate the effect of preoperative PENG block application on postoperative pain, opioid requirement, mobilisation time, hip joint patency and length of hospital stay in patients undergoing THA surgery. The secondary outcome was to investigate the effect of PENG block on perioperative haemodynamics and postoperative side effects.

For multimodal analgesia, 10 ml 0.5% bupivacaine + 10 ml 2% lidocaine is infiltrated into the surgical wound incision line by the surgical team at the end of surgery. After tramadol 50 mg loading with PCA device, a basal rate of 5-10 mg/hour (20 mg bolus dose + 30 minutes lock time) is given with paracetamol 10 mg/kg iv (8 hours interval).

Eligibility criteria: Inclusion Criteria:

* THA performed by posterior approach
* 40-85 age range
* ASA 1-3

Exclusion Criteria:

Under 40 years of age, over 85 years of age,

* ASA 4 and above,
* Cognitive impairment (Alzheimer's disease, dementia, delirium etc.),
* Hip fracture,
* Application site infection,
* Allergy to local anaesthetic agents,
* Patients are non-consenting patients.

Primary outcomes:
measure: postoperative pain score
timeFrame: recovery room 30 min, 12., 24. and 48. hours in the postoperative period
measure: mobilisation time
timeFrame: 24 -48 hours
measure: hip joint patency
timeFrame: 24. hours
measure: total opioid consumption
timeFrame: 48 hours
Secondary outcomes:
measure: PENG block side effects
timeFrame: The first 48 hours after performing the PENG block
measure: Perioperative haemodynamic data
timeFrame: T1: 30 minutes (min) after spinal anesthesia, T2: at the end of the surgical procedure, T3: at 30 minutes after recovery
measure: length of hospital stay
timeFrame: day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: UmraniyeERH
state: Umraniye
Study officials:
affiliation: Ümraniye Training and Education hospital
name: zeliha tuncel
role: STUDY_DIRECTOR
References: