- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06183528
Effects of Pericapsular Nerve Group Block on Postoperative Recovery for Total Hip Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: zeliha tuncel, ass prof
- Phone Number: +905053577483
- Email: zelihalara@yahoo.com
Study Contact Backup
- Name: hale arkan tuna, specialist dr
- Phone Number: +905303705619
- Email: halearkan@yahoo.com.tr
Study Locations
-
-
Umraniye
-
Istanbul, Umraniye, Turkey (Türkiye), 34734
- Recruiting
- UmraniyeERH
-
Contact:
- zeliha tuncel, ass prof
- Phone Number: +905053577483
- Email: zelihalara@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: PENG group
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 after spinal anaesthesia.
|
With ultrasonography-guided PENG block, the femoral, obturator and accessory obturator nerve branches that provide sensory innervation of the anterior surface of the hip joint capsule are blocked .
|
|
Placebo Comparator: non-PENG group
group non-PENG, surgery was started without PENG block after spinal anaesthesia.
|
With ultrasonography-guided PENG block, the femoral, obturator and accessory obturator nerve branches that provide sensory innervation of the anterior surface of the hip joint capsule are blocked .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative pain score
Time Frame: recovery room 30 min, 12., 24. and 48. hours in the postoperative period
|
VAS pain score
|
recovery room 30 min, 12., 24. and 48. hours in the postoperative period
|
|
mobilisation time
Time Frame: 24 -48 hours
|
walking 5 steps with walker
|
24 -48 hours
|
|
hip joint patency
Time Frame: 24. hours
|
Measurement of joint movement angle with goniometer (angle)
|
24. hours
|
|
total opioid consumption
Time Frame: 48 hours
|
Tramadol total usage (mg)
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PENG block side effects
Time Frame: The first 48 hours after performing the PENG block
|
motor block, nausea, vomiting, anaphylaxis, nerve damage
|
The first 48 hours after performing the PENG block
|
|
Perioperative haemodynamic data
Time Frame: T1: 30 minutes (min) after spinal anesthesia, T2: at the end of the surgical procedure, T3: at 30 minutes after recovery
|
heart rate, mean arterial pressure
|
T1: 30 minutes (min) after spinal anesthesia, T2: at the end of the surgical procedure, T3: at 30 minutes after recovery
|
|
length of hospital stay
Time Frame: day
|
hospitalization and discharge time for surgery
|
day
|
Collaborators and Investigators
Investigators
- Study Director: zeliha tuncel, Ümraniye Training and Education hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Nervous System Diseases
- Postoperative Complications
- Pathologic Processes
- Neurobehavioral Manifestations
- Perceptual Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Agnosia
- Digestive System and Oral Physiological Phenomena
- Dentistry
- Dental Physiological Phenomena
- Dental Occlusion
Other Study ID Numbers
- UERH-AR-ZT-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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