Hip FracturePENG-PKPNCT07534137
Effect of PENG Block on Postoperative Tramadol Consumption in Partial Hip Prosthesis Surgery
A study testing PENG Block and General Anesthesia in people with Hip Fracture and Postoperative Pain, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effect of ultrasound-guided pericapsular nerve group (PENG) block on postoperative tramadol consumption, pain scores, and clinical outcomes in patients undergoing partial hip prosthesis surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hip Fracture, Postoperative Pain
- What is being tested?
- PENG Block and General Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep University Faculty Of Medicine
Gaziantep, 27310
About this study
Official title: 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
This study aims to evaluate the effect of ultrasound-guided pericapsular nerve group (PENG) block on postoperative tramadol consumption, pain scores, and clinical outcomes in patients undergoing partial hip prosthesis surgery. Patients aged 18-75 years scheduled for surgery under general anesthesia were divided into two groups: those receiving PENG block and those not receiving the block. Postoperative tramadol consumption within the first 24 hours, visual analog scale (VAS) and numeric rating scale (NRS) scores, hemodynamic parameters, additional analgesic requirements, and recovery characteristics were recorded and compared between groups. The findings of this study are expected to contribute to optimizing multimodal analgesia strategies in hip surgery.
Read the 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.
- Conditions
- Hip Fracture, Postoperative Pain
- Being tested
- PENG Block, General Anesthesia
- Keywords
- peng block, Pericapsular nerve group block, Hip surgery, Postoperative pain, Tramadol consumption, Regional anesthesia
- Medical subject headings
- Hip Fractures, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG BlockProcedure or surgery
Ultrasound-guided pericapsular nerve group block performed with 20 mL of 0.5% bupivacaine after induction of general anesthesia.
General AnesthesiaProcedure or surgery
Standard general anesthesia administered without regional nerve block.
| Study group | Role | What they receive |
|---|---|---|
| PENG Block Group | Experimental | Patients receiving ultrasound-guided PENG block after induction of general anesthesia. Receives: Procedure: PENG Block |
| Control Group | Active comparator | Control Group Receives: Procedure: General Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Tramadol Consumption Within 24 Hours After Surgery
Total amount of tramadol (mg) consumed by patients during the first 24 hours after surgery.
Measured: 24 hours postoperatively
Secondary outcomes (5)
Postoperative VAS Pain Scores
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.
Measured: 0, 10, 30, 60 minutes and 2, 4, 6, 12, 24 hours postoperatively
Postoperative NRS Pain Scores
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.
Measured: 0, 10, 30, 60 minutes and 2, 4, 6, 12, 24 hours postoperatively
Intraoperative Remifentanil Consumption
Total amount of remifentanil used during surgery.
Measured: Intraoperative period
Additional Analgesic Requirement
Requirement for additional analgesic medication in the postoperative period.
Measured: 24 hours postoperatively
Postoperative Complications
Incidence of complications including nausea, vomiting, hypotension, hypertension, arrhythmia, and pruritus.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Mar 2022
- Primary completion1 Oct 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to two parallel groups: a PENG block group receiving ultrasound-guided pericapsular nerve group block after induction of general anesthesia, and a control group receiving general anesthesia alone.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yavuz Saygılı, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534137
- Sponsor's protocol ID
- GAUN-2022-248
- Acronym
- PENG-PKP
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional policies and patient confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07534137
- Acronym / sponsor ID
- PENG-PKP / GAUN-2022-248
- Conditions
- Hip Fracture, Postoperative Pain
- Keywords
- peng block, Pericapsular nerve group block, Hip surgery, Postoperative pain, Tramadol consumption, Regional anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effect of ultrasound-guided pericapsular nerve group (PENG) block on postoperative tramadol consumption, pain scores, and clinical outcomes in patients undergoing partial hip prosthesis surgery. Patients aged 18-75 years scheduled for surgery under general anesthesia were divided into two groups: those receiving PENG block and those not receiving the block. Postoperative tramadol consumption within the first 24 hours, visual analog scale (VAS) and numeric rating scale (NRS) scores, hemodynamic parameters, additional analgesic requirements, and recovery characteristics were recorded and compared between groups. The findings of this study are expected to contribute to optimizing multimodal analgesia strategies in hip surgery.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to two parallel groups: a PENG block group receiving ultrasound-guided pericapsular nerve group block after induction of general anesthesia, and a control group receiving general anesthesia alone.
| Arm | Type | Receives |
|---|---|---|
| PENG Block Group | Experimental | Procedure: PENG BlockPatients receiving ultrasound-guided PENG block after induction of general anesthesia. |
| Control Group | Active comparator | Procedure: General AnesthesiaControl Group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PENG BlockUltrasound-guided pericapsular nerve group block performed with 20 mL of 0.5% bupivacaine after induction of general anesthesia. | Procedure or surgery | PENG Block Group |
| General AnesthesiaStandard general anesthesia administered without regional nerve block. | Procedure or surgery | Control Group |
Primary outcome
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.
5 secondary outcomes
Postoperative VAS Pain Scores
Time frame: 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
Intraoperative Remifentanil Consumption
Time frame: Intraoperative period
Additional Analgesic Requirement
Time frame: 24 hours postoperatively
Postoperative Complications
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional policies and patient confidentiality considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PENG Block and General Anesthesia in people with Hip Fracture and Postoperative Pain, run by University of Gaziantep at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Tramadol Consumption Within 24 Hours After Surgery (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.