- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07534137
Effect of PENG Block on Postoperative Tramadol Consumption in Partial Hip Prosthesis Surgery (PENG-PKP)
Comparison of Postoperative Tramadol Consumption, Clinical Effects, and Side Effects in Patients With and Without PENG (Pericapsular Nerve Group) Block in Partial Hip Prosthesis Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Postoperative pain management in hip surgery remains a significant clinical challenge, particularly in elderly patients. Effective analgesia is essential to reduce opioid consumption, improve patient comfort, and enhance recovery. The pericapsular nerve group (PENG) block is a relatively new regional anesthesia technique that targets the articular branches of the femoral, obturator, and accessory obturator nerves, providing analgesia to the anterior hip capsule.
This prospective study was conducted to compare the clinical effects of PENG block in patients undergoing partial hip prosthesis surgery under general anesthesia. A total of 48 patients aged between 18 and 75 years were included and divided into two groups: the PENG group (Group P), which received ultrasound-guided PENG block with 20 mL of 0.5% bupivacaine after induction of general anesthesia, and the control group (Group K), which received general anesthesia alone.
Demographic data, intraoperative anesthetic requirements, and postoperative parameters were recorded. The primary outcome measure was total tramadol consumption within the first 24 hours after surgery. Secondary outcomes included postoperative pain scores (VAS and NRS), hemodynamic parameters (mean arterial pressure and heart rate), remifentanil consumption, need for additional analgesia, bispectral index (BIS) values, patient comfort score, modified Aldrete recovery score, Riker agitation-sedation scale, and incidence of complications such as nausea, vomiting, hypotension, hypertension, and arrhythmia.
The results of this study are intended to evaluate the effectiveness of PENG block as a component of multimodal analgesia and to determine its impact on opioid consumption and postoperative recovery in patients undergoing hip surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Gaziantep, Turkey (Türkiye), 27310
- Gaziantep University Faculty Of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged between 18 and 75 years
- Patients scheduled for partial hip prosthesis surgery
- Patients classified as ASA physical status I-III
- Patients who provided written informed consent
Exclusion Criteria:
- Known allergy to local anesthetics
- Coagulation disorders or anticoagulant therapy contraindicating regional anesthesia
- Infection at the injection site
- Severe systemic disease (ASA IV or higher)
- Cognitive impairment preventing reliable pain assessment
- Refusal to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
|
Standard general anesthesia administered without regional nerve block.
|
|
Experimental: PENG Block Group
Patients receiving ultrasound-guided PENG block after induction of general anesthesia.
|
Ultrasound-guided pericapsular nerve group block performed with 20 mL of 0.5% bupivacaine after induction of general anesthesia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Tramadol Consumption Within 24 Hours After Surgery
Time Frame: 24 hours postoperatively
|
Total amount of tramadol (mg) consumed by patients during the first 24 hours after surgery.
|
24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraoperative Remifentanil Consumption
Time Frame: Intraoperative period
|
Total amount of remifentanil used during surgery.
|
Intraoperative period
|
|
Additional Analgesic Requirement
Time Frame: 24 hours postoperatively
|
Requirement for additional analgesic medication in the postoperative period.
|
24 hours postoperatively
|
|
Postoperative Complications
Time Frame: 24 hours postoperatively
|
Incidence of complications including nausea, vomiting, hypotension, hypertension, arrhythmia, and pruritus.
|
24 hours postoperatively
|
|
Postoperative VAS Pain Scores
Time Frame: 0, 10, 30, 60 minutes and 2, 4, 6, 12, 24 hours postoperatively
|
Visual Analog Scale (VAS) pain scores ranging from 0 to 10, where 0 indicates no pain and 10 indicates worst imaginable pain, measured at predefined postoperative time points.
|
0, 10, 30, 60 minutes and 2, 4, 6, 12, 24 hours postoperatively
|
|
Postoperative NRS Pain Scores
Time Frame: 0, 10, 30, 60 minutes and 2, 4, 6, 12, 24 hours postoperatively
|
Numeric Rating Scale (NRS) pain scores ranging from 0 to 10, where 0 indicates no pain and 10 indicates worst possible pain, measured at predefined postoperative time points.
|
0, 10, 30, 60 minutes and 2, 4, 6, 12, 24 hours postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- Wounds and Injuries
- Postoperative Complications
- Pathologic Processes
- Leg Injuries
- Fractures, Bone
- Femoral Fractures
- Hip Injuries
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Hip Fractures
- Anesthesia and Analgesia
- Anesthesia
- Anesthesia, General
Other Study ID Numbers
- GAUN-2022-248
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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