Morphine ConsumptionNCT07906613
Ultrasound-Guided Pericapsular Nerve Group Block for Pain Control After Hip Surgery
A study testing Ultrasound-Guided Pericapsular Nerve Group Block with Bupivacaine in people with Morphine Consumption and Postoperative Pain, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluated whether an ultrasound-guided pericapsular nerve group (PENG) block could reduce pain and morphine use during the first 24 hours after hip surgery. A PENG block involves injecting a local anesthetic near nerves that carry pain signals from the hip. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Morphine Consumption, Postoperative Pain
- What is being tested?
- Ultrasound-Guided Pericapsular Nerve Group Block with Bupivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jul 2021to 11 Jan 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20 to 80 years.
- American Society of Anesthesiologists (ASA) physical status I to III.
- Scheduled for elective primary total hip arthroplasty for degenerative coxarthrosis under general anesthesia.
- Willingness to participate and provision of informed consent.
Who cannot join
- ASA physical status IV.
- Sequelae of developmental dysplasia of the hip causing anatomical abnormalities.
- History of previous surgery on the hip.
- Multiple trauma.
- Hip arthroplasty for femoral neck fracture.
- Refusal to participate.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sivas Cumhuriyet University Hospital
Sivas, Merkez, 58140
About this study
Official title: Efficacy of Ultrasound-Guided Pericapsular Nerve Group Block
This study evaluated whether an ultrasound-guided pericapsular nerve group (PENG) block could reduce pain and morphine use during the first 24 hours after hip surgery. A PENG block involves injecting a local anesthetic near nerves that carry pain signals from the hip.
The study included 40 adults aged 20-80 years undergoing planned hip surgery under general anesthesia at Cumhuriyet University Hospital. Participants were randomly assigned to two groups of 20. Before surgery, one group received a PENG block with bupivacaine, a local anesthetic. The other group received an injection of normal saline in the same location as a placebo. Participants and the clinicians assessing postoperative outcomes did not know which injection had been given.
After surgery, both groups received morphine through a patient-controlled pump. Pain scores, morphine consumption, the need for additional pain medication, and side effects including nausea, vomiting, and constipation were assessed over 24 hours.
- Conditions
- Morphine Consumption, Postoperative Pain
- Being tested
- Ultrasound-Guided Pericapsular Nerve Group Block with Bupivacaine, Ultrasound-Guided Placebo Injection with Normal Saline
- Keywords
- Pericapsular Nerve Group Block, PENG Block, Hip Surgery, Bupivacaine, Morphine Consumption, Patient-Controlled Analgesia, Ultrasound-Guided Regional Anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Pericapsular Nerve Group Block with BupivacaineProcedure or surgery
A single ultrasound-guided pericapsular nerve group (PENG) block was performed after induction of general anesthesia and before surgical incision. Using an in-plane approach, bupivacaine 1 mg/kg diluted with 0.9% sodium chloride to a total volume of 30 mL was injected between the psoas tendon and the iliopubic eminence.
Ultrasound-Guided Placebo Injection with Normal SalineProcedure or surgery
A single ultrasound-guided injection of 30 mL of 0.9% sodium chloride was administered at the same anatomical location as the PENG block, between the psoas tendon and the iliopubic eminence, after induction of general anesthesia and before surgical incision.
| Study group | Role | What they receive |
|---|---|---|
| PENG Block Group | Experimental | Participants received a single ultrasound-guided pericapsular nerve group (PENG) block after induction of general anesthesia and before surgical incision. Bupivacaine 1 mg/kg was diluted with 0.9% sodium chloride to a total volume of 30 mL. Postoperative analgesia was provided with intravenous patient-controlled morphine, and participants were followed for 24 hours. Receives: Procedure: Ultrasound-Guided Pericapsular Nerve Group Block with Bupivacaine |
| Placebo Group | Placebo comparator | Participants received a single ultrasound-guided injection of 30 mL of 0.9% sodium chloride at the same anatomical location used for the pericapsular nerve group (PENG) block, after induction of general anesthesia and before surgical incision. Postoperative analgesia was provided with intravenous patient-controlled morphine, and participants were followed for 24 hours. Receives: Procedure: Ultrasound-Guided Placebo Injection with Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Morphine Consumption During the First 24 Hours After Surgery
Total intravenous morphine consumption, measured in milligrams, delivered through the patient-controlled analgesia pump during the first 24 hours after surgery.
Measured: First 24 hours after surgery
Secondary outcomes (9)
Postoperative Pain Intensity Assessed Using the Visual Analog Scale
Postoperative pain intensity was assessed using a 10-cm visual analog scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Measured: At 1, 2, 3, 4, 8, 16, and 24 hours after surgery
Time to First Rescue Analgesia
Time, measured in hours, from the end of surgery to the first requirement for rescue analgesia. Rescue analgesia was administered when the visual analog scale pain score exceeded 5.
Measured: During the first 24 hours after surgery
Participants Requiring Rescue Analgesia
Number of participants requiring rescue analgesia during the first 24 postoperative hours. Rescue analgesia consisted of intravenous tramadol 100 mg and intravenous paracetamol 1000 mg when the visual analog scale pain score exceeded 5.
Measured: During the first 24 hours after surgery
Incidence of Postoperative Nausea
Number of participants experiencing postoperative nausea during the first 24 hours after surgery.
Measured: During the first 24 hours after surgery, assessed at 1, 2, 3, 4, 8, 16, and 24 hours
Incidence of Postoperative Vomiting
Number of participants experiencing postoperative vomiting during the first 24 hours after surgery.
Measured: During the first 24 hours after surgery, assessed at 1, 2, 3, 4, 8, 16, and 24 hours
Incidence of Postoperative Constipation
Number of participants experiencing constipation during the first 24 hours after surgery.
Measured: During the first 24 hours after surgery, assessed at 1, 2, 3, 4, 8, 16, and 24 hours
Postoperative Heart Rate
Heart rate, measured in beats per minute, at each postoperative assessment.
Measured: At 1, 2, 3, 4, 8, 16, and 24 hours after surgery
Postoperative Mean Arterial Pressure
Mean arterial pressure, measured in mmHg, at each postoperative assessment.
Measured: At 1, 2, 3, 4, 8, 16, and 24 hours after surgery
Patient Satisfaction
Patient satisfaction was assessed using four ordered categories: poor, fair, good, and very good. Categories toward very good indicate greater satisfaction.
Measured: At 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start2 Jul 2021
- Primary completion11 Jan 2022
- Study completion11 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morphine ConsumptionStudies 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 in a 1:1 ratio to receive either an ultrasound-guided PENG block with bupivacaine or a placebo injection with normal saline. Each group included 20 participants, with postoperative follow-up for 24 hours.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozan Altun, Cumhuriyet University
- Investigators
- İclal Özdemir Kol, MD-Prof.Dr., Principal investigator, Sivas Cumhuriyet University, Faculty of Medicine, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906613
- Sponsor's protocol ID
- 2021-06/11
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ultrasound-Guided Pericapsular Nerve Group Block
- ClinicalTrials.gov ID
- NCT07906613
- Acronym / sponsor ID
- 2021-06/11
- Conditions
- Morphine Consumption, Postoperative Pain
- Keywords
- Pericapsular Nerve Group Block, PENG Block, Hip Surgery, Bupivacaine, Morphine Consumption, Patient-Controlled Analgesia, Ultrasound-Guided Regional Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 11 Jan 2022 (actual)
- Study completion
- 11 Jan 2022 (actual)
- First posted
- 30 Oct 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 evaluated whether an ultrasound-guided pericapsular nerve group (PENG) block could reduce pain and morphine use during the first 24 hours after hip surgery. A PENG block involves injecting a local anesthetic near nerves that carry pain signals from the hip.
The study included 40 adults aged 20-80 years undergoing planned hip surgery under general anesthesia at Cumhuriyet University Hospital. Participants were randomly assigned to two groups of 20. Before surgery, one group received a PENG block with bupivacaine, a local anesthetic. The other group received an injection of normal saline in the same location as a placebo. Participants and the clinicians assessing postoperative outcomes did not know which injection had been given.
After surgery, both groups received morphine through a patient-controlled pump. Pain scores, morphine consumption, the need for additional pain medication, and side effects including nausea, vomiting, and constipation were assessed over 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to receive either an ultrasound-guided PENG block with bupivacaine or a placebo injection with normal saline. Each group included 20 participants, with postoperative follow-up for 24 hours.
| Arm | Type | Receives |
|---|---|---|
| PENG Block Group | Experimental | Procedure: Ultrasound-Guided Pericapsular Nerve Group Block with BupivacaineParticipants received a single ultrasound-guided pericapsular nerve group (PENG) block after induction of general anesthesia and before surgical incision. Bupivacaine 1 mg/kg was diluted with 0.9% sodium chloride to a total volume of 30 mL. Postoperative analgesia was provided with intravenous patient-controlled morphine, and participants were followed for 24 hours. |
| Placebo Group | Placebo comparator | Procedure: Ultrasound-Guided Placebo Injection with Normal SalineParticipants received a single ultrasound-guided injection of 30 mL of 0.9% sodium chloride at the same anatomical location used for the pericapsular nerve group (PENG) block, after induction of general anesthesia and before surgical incision. Postoperative analgesia was provided with intravenous patient-controlled morphine, and participants were followed for 24 hours. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 20 to 80 years.
- American Society of Anesthesiologists (ASA) physical status I to III.
- Scheduled for elective primary total hip arthroplasty for degenerative coxarthrosis under general anesthesia.
- Willingness to participate and provision of informed consent.
Key exclusion criteria (6 listed)
- ASA physical status IV.
- Sequelae of developmental dysplasia of the hip causing anatomical abnormalities.
- History of previous surgery on the hip.
- Multiple trauma.
- Hip arthroplasty for femoral neck fracture.
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 |
|---|---|---|
| Ultrasound-Guided Pericapsular Nerve Group Block with BupivacaineA single ultrasound-guided pericapsular nerve group (PENG) block was performed after induction of general anesthesia and before surgical incision. Using an in-plane approach, bupivacaine 1 mg/kg diluted with 0.9% sodium chloride to a total volume of 30 mL was injected between the psoas tendon and the iliopubic eminence. | Procedure or surgery | PENG Block Group |
| Ultrasound-Guided Placebo Injection with Normal SalineA single ultrasound-guided injection of 30 mL of 0.9% sodium chloride was administered at the same anatomical location as the PENG block, between the psoas tendon and the iliopubic eminence, after induction of general anesthesia and before surgical incision. | Procedure or surgery | Placebo Group |
Primary outcome
Cumulative Morphine Consumption During the First 24 Hours After Surgery
Time frame: First 24 hours after surgery
Total intravenous morphine consumption, measured in milligrams, delivered through the patient-controlled analgesia pump during the first 24 hours after surgery.
9 secondary outcomes
Postoperative Pain Intensity Assessed Using the Visual Analog Scale
Time frame: At 1, 2, 3, 4, 8, 16, and 24 hours after surgery
Time to First Rescue Analgesia
Time frame: During the first 24 hours after surgery
Participants Requiring Rescue Analgesia
Time frame: During the first 24 hours after surgery
Incidence of Postoperative Nausea
Time frame: During the first 24 hours after surgery, assessed at 1, 2, 3, 4, 8, 16, and 24 hours
Incidence of Postoperative Vomiting
Time frame: During the first 24 hours after surgery, assessed at 1, 2, 3, 4, 8, 16, and 24 hours
Incidence of Postoperative Constipation
Time frame: During the first 24 hours after surgery, assessed at 1, 2, 3, 4, 8, 16, and 24 hours
Postoperative Heart Rate
Time frame: At 1, 2, 3, 4, 8, 16, and 24 hours after surgery
Postoperative Mean Arterial Pressure
Time frame: At 1, 2, 3, 4, 8, 16, and 24 hours after surgery
Patient Satisfaction
Time frame: At 24 hours after surgery
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 3 Nov 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data with other researchers.
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.
İclal Özdemir Kol, MD-Prof.Dr. principal investigator
Sivas Cumhuriyet University, Faculty of Medicine, Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Pericapsular Nerve Group Block with Bupivacaine in people with Morphine Consumption and Postoperative Pain, run by Cumhuriyet University 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 3 Nov 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. Some participants in this study may receive a placebo. 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?
Cumulative Morphine Consumption During the First 24 Hours After Surgery (time frame: First 24 hours after surgery). 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 3 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.