Pain, PostoperativeNCT05056675
The PENG Block in Elective Hip Surgery and Its Effect on Postoperative Pain and Length of Stay.
A study testing PENG block in people with Pain, Postoperative, run by Hôpital Fribourgeois at 1 site in Switzerland.
Trial summary
Effective postoperative pain management in elective hip surgery is crucial for the patients well-being, rapid mobilisation and potential reduction of length of stay. In addition to standard intravenous pain medication, anaesthetic blocks are reportedly effective. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- PENG block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2022to 30 Nov 2023
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anterior total hip arthroplasty for hip osteoarthritis
- Surgical hip dislocation for femoro-acetabular impingement (type cam-/pincer)
- Age 16-85 years
- American Society of Anesthesiologists (ASA) physical status 1 to 3
Who cannot join
- Patient refusal/no informed consent
- Inability to give informed consent
- Lateral approach for total hip arthroplasty
- Bilateral procedure
- Additional osteotomies of the femur and/or acetabulum
- Previous hip \& pelvis surgery
Show all 11Show fewer
- Chronic opioid users
- Known allergy or intolerance to medications used in the trial (local anesthetic, opioid)
- Infection at the injection site
- Body mass index > 40kg/m2
- Spinal anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The PENG Block in Elective Hip Surgery and Its Effect on Postoperative Pain and Length of Stay: A Multidisciplinary Prospective Randomized Double-blind Controlled Trial.
Effective postoperative pain management in elective hip surgery is crucial for the patients well-being, rapid mobilisation and potential reduction of length of stay. In addition to standard intravenous pain medication, anaesthetic blocks are reportedly effective. Recently, the PENG block, a pericapsular pain block without impairment of the motor function has been introduced in literature and performed at the investigator's hospital (HFR Fribourg, Switzerland) for total hip arthroplasty and surgical hip dislocation - the two most commonly performed elective hip surgeries.
As high-quality evidence on the effectiveness of this novel block is lacking, the investigator's objective is to evaluate the effectiveness of (1) patient-reported pain reduction, (2) total consumption of postoperative morphine, and the length of stay at the hospital.
Read the detailed description
Forty patients undergoing total hip arthroplasty and 40 patients undergoing surgical hip dislocation will be enrolled in a prospective, double-blind, controlled trial performed at the investigator's hospital.
This study will be the first prospective study evaluating the potential of this pain block in elective hip surgery potentially affecting both patients' postoperative well-being and optimizing costs of the hospital by reducing length of stay.
- Conditions
- Pain, Postoperative
- Being tested
- PENG block, Placebo
- Keywords
- PENG block, Postoperative pain, Elective hip surgery, Total hip arthroplasty, Surgical hip dislocation
- Medical subject headings
- 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
All patients will undergo the same preoperative, standardized protocol. Upon arrival to the operating room, patients will be placed in supine position. Routine, standard pre-medication will be applied before induction of general anesthesia. After intubation, the PENG block is performed. Under sonographic guidance using a curvilinear probe, puncture will be performed in a lateromedial direction until the needle tip reaches the plane between the iliopsoas tendon and periosteum and between the anterior inferior iliac spine and iliopubic eminence. After a negative aspiration test, the blinded test item will be injected in the plane beneath the iliopsoas muscle. Patients will be randomly assigned to receive the test item (20 mL of ropivacaine 0.5%, Naropin). The anesthesiologist and the surgeon are blinded to the product injected.
PlaceboProcedure or surgery
ll patients will undergo the same preoperative, standardized protocol. Upon arrival to the operating room, patients will be placed in supine position. Routine, standard pre-medication will be applied before induction of general anesthesia. After intubation, the PENG block is performed. Under sonographic guidance using a curvilinear probe, puncture will be performed in a lateromedial direction until the needle tip reaches the plane between the iliopsoas tendon and periosteum and between the anterior inferior iliac spine and iliopubic eminence. After a negative aspiration test, the blinded test item will be injected in the plane beneath the iliopsoas muscle. Patients will be randomly assigned to receive the placebo (20 mL of NaCL 0.9%). The anesthesiologist and the surgeon are blinded to the product injected.
| Study group | Role | What they receive |
|---|---|---|
| PENG block for anterior total hip arthroplasty or surgical hip dislocation | Experimental | All patients will undergo the same preoperative, standardized protocol. Upon arrival to the operating theatre, routine, standard pre-medication will be applied before induction of general anesthesia. After intubation, the PENG block is performed. Under sonographic guidance, 20 mL of 0.5% ropivacaine iv is injected. Receives: Procedure: PENG block |
| Placebo for anterior total hip arthroplasty or surgical hip dislocation | Placebo comparator | All patients will undergo the same preoperative, standardized protocol. Upon arrival to the operating theatre, routine, standard pre-medication will be applied before induction of general anesthesia. After intubation, the PENG block is performed. Under sonographic guidance, 20 mL of NaCL 0.9% is injected. Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS)
Using a ruler, the score is determined by measuring the distance (cm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0 to 10. A higher score indicates greater pain intensity
Measured: Reduction of postoperative pain in the first 24 hours after surgery
Secondary outcomes (2)
Total morphine consumption (morphine equivalent dose)
Total morphine consumption in morphine equivalent dose (MED) in the fist 24 hours after surgery.
Measured: Total consumption of postoperative morphine in the first 24 hours after surgery
Length of stay (days)
The length of hospital stay is measured in days, from the day of surgery (day 0) to the patient's discharge from the hospital. Discharge occurs up to a maximum of 7 days after surgery when the 3 following criteria are met: the scar must be dry, the pain must no longer require morphine and the patient must be able to walk with crutches
Measured: Length of stay at the hospital (in days) from the day of the surgery (day 0) to the day of discharge, up to a maximum of 7 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start1 Jun 2022
- Primary completion1 Apr 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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
- Interdisciplinary, prospective, double-blind (participant and investigator), placebo-controlled, parallel-group study (experimental study, level of evidence I).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Fribourgeois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthieu Hanauer, Hôpital Fribourgeois
- Investigators
- Matthieu Hanauer, M.D., Principal investigator, HFR Fribourg - Hôpital cantonal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056675
- Sponsor's protocol ID
- 2021-01792
- Status last verified
- Jan 2024
- First submitted
- 28 Aug 2021
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD and results of this study will be presented at national and international orthopedic meetings and will be submitted to highly-ranked peer reviewed orthopedic journals.
Publications
Learmonth ID, Young C, Rorabeck C. The operation of the century: total hip replacement. Lancet. 2007 Oct 27;370(9597):1508-19. doi: 10.1016/S0140-6736(07)60457-7.
PubMed 17964352Birnbaum K, Prescher A, Hessler S, Heller KD. The sensory innervation of the hip joint--an anatomical study. Surg Radiol Anat. 1997;19(6):371-5. doi: 10.1007/BF01628504.
PubMed 9479711Guay J, Parker MJ, Griffiths R, Kopp S. Peripheral nerve blocks for hip fractures. Cochrane Database Syst Rev. 2017 May 11;5(5):CD001159. doi: 10.1002/14651858.CD001159.pub2.
PubMed 28494088Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
PubMed 30063657Cuschieri S. The CONSORT statement. Saudi J Anaesth. 2019 Apr;13(Suppl 1):S27-S30. doi: 10.4103/sja.SJA_559_18.
PubMed 30930716Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.
PubMed 34196965Bell ML, Kenward MG, Fairclough DL, Horton NJ. Differential dropout and bias in randomised controlled trials: when it matters and when it may not. BMJ. 2013 Jan 21;346:e8668. doi: 10.1136/bmj.e8668.
PubMed 23338004
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PENG Block in Elective Hip Surgery and Its Effect on Postoperative Pain and Length of Stay: A Multidisciplinary Prospective Randomized Double-blind Controlled Trial.
- ClinicalTrials.gov ID
- NCT05056675
- Acronym / sponsor ID
- 2021-01792
- Conditions
- Pain, Postoperative
- Keywords
- PENG block, Postoperative pain, Elective hip surgery, Total hip arthroplasty, Surgical hip dislocation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Hôpital FribourgeoisUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 24 Sep 2021 (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.
Effective postoperative pain management in elective hip surgery is crucial for the patients well-being, rapid mobilisation and potential reduction of length of stay. In addition to standard intravenous pain medication, anaesthetic blocks are reportedly effective. Recently, the PENG block, a pericapsular pain block without impairment of the motor function has been introduced in literature and performed at the investigator's hospital (HFR Fribourg, Switzerland) for total hip arthroplasty and surgical hip dislocation - the two most commonly performed elective hip surgeries.
As high-quality evidence on the effectiveness of this novel block is lacking, the investigator's objective is to evaluate the effectiveness of (1) patient-reported pain reduction, (2) total consumption of postoperative morphine, and the length of stay at the hospital.
Detailed description
Forty patients undergoing total hip arthroplasty and 40 patients undergoing surgical hip dislocation will be enrolled in a prospective, double-blind, controlled trial performed at the investigator's hospital.
This study will be the first prospective study evaluating the potential of this pain block in elective hip surgery potentially affecting both patients' postoperative well-being and optimizing costs of the hospital by reducing length of stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Interdisciplinary, prospective, double-blind (participant and investigator), placebo-controlled, parallel-group study (experimental study, level of evidence I).
| Arm | Type | Receives |
|---|---|---|
| PENG block for anterior total hip arthroplasty or surgical hip dislocation | Experimental | Procedure: PENG blockAll patients will undergo the same preoperative, standardized protocol. Upon arrival to the operating theatre, routine, standard pre-medication will be applied before induction of general anesthesia. After intubation, the PENG block is performed. Under sonographic guidance, 20 mL of 0.5% ropivacaine iv is injected. |
| Placebo for anterior total hip arthroplasty or surgical hip dislocation | Placebo comparator | Procedure: PlaceboAll patients will undergo the same preoperative, standardized protocol. Upon arrival to the operating theatre, routine, standard pre-medication will be applied before induction of general anesthesia. After intubation, the PENG block is performed. Under sonographic guidance, 20 mL of NaCL 0.9% is injected. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Anterior total hip arthroplasty for hip osteoarthritis
- Surgical hip dislocation for femoro-acetabular impingement (type cam-/pincer)
- Age 16-85 years
- American Society of Anesthesiologists (ASA) physical status 1 to 3
Key exclusion criteria (11 listed)
- Patient refusal/no informed consent
- Inability to give informed consent
- Lateral approach for total hip arthroplasty
- Bilateral procedure
- Additional osteotomies of the femur and/or acetabulum
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 blockAll patients will undergo the same preoperative, standardized protocol. Upon arrival to the operating room, patients will be placed in supine position. Routine, standard pre-medication will be applied before induction of general anesthesia. After intubation, the PENG block is performed. Under sonographic guidance using a curvilinear probe, puncture will be performed in a lateromedial direction until the needle tip reaches the plane between the iliopsoas tendon and periosteum and between the anterior inferior iliac spine and iliopubic eminence. After a negative aspiration test, the blinded test item will be injected in the plane beneath the iliopsoas muscle. Patients will be randomly assigned to receive the test item (20 mL of ropivacaine 0.5%, Naropin). The anesthesiologist and the surgeon are blinded to the product injected. | Procedure or surgery | PENG block for anterior total hip arthroplasty or surgical hip dislocation |
| Placeboll patients will undergo the same preoperative, standardized protocol. Upon arrival to the operating room, patients will be placed in supine position. Routine, standard pre-medication will be applied before induction of general anesthesia. After intubation, the PENG block is performed. Under sonographic guidance using a curvilinear probe, puncture will be performed in a lateromedial direction until the needle tip reaches the plane between the iliopsoas tendon and periosteum and between the anterior inferior iliac spine and iliopubic eminence. After a negative aspiration test, the blinded test item will be injected in the plane beneath the iliopsoas muscle. Patients will be randomly assigned to receive the placebo (20 mL of NaCL 0.9%). The anesthesiologist and the surgeon are blinded to the product injected. | Procedure or surgery | Placebo for anterior total hip arthroplasty or surgical hip dislocation |
Primary outcome
Visual analogue scale (VAS)
Time frame: Reduction of postoperative pain in the first 24 hours after surgery
Using a ruler, the score is determined by measuring the distance (cm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0 to 10. A higher score indicates greater pain intensity
2 secondary outcomes
Total morphine consumption (morphine equivalent dose)
Time frame: Total consumption of postoperative morphine in the first 24 hours after surgery
Length of stay (days)
Time frame: Length of stay at the hospital (in days) from the day of the surgery (day 0) to the day of discharge, up to a maximum of 7 postoperative days
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 2 Feb 2024.
- Background: PubMed 17964352Learmonth ID, Young C, Rorabeck C. The operation of the century: total hip replacement. Lancet. 2007 Oct 27;370(9597):1508-19. doi: 10.1016/S0140-6736(07)60457-7.
- Background: PubMed 9479711Birnbaum K, Prescher A, Hessler S, Heller KD. The sensory innervation of the hip joint--an anatomical study. Surg Radiol Anat. 1997;19(6):371-5. doi: 10.1007/BF01628504.
- Background: PubMed 28494088Guay J, Parker MJ, Griffiths R, Kopp S. Peripheral nerve blocks for hip fractures. Cochrane Database Syst Rev. 2017 May 11;5(5):CD001159. doi: 10.1002/14651858.CD001159.pub2.
- Background: PubMed 30063657Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
- Background: PubMed 30930716Cuschieri S. The CONSORT statement. Saudi J Anaesth. 2019 Apr;13(Suppl 1):S27-S30. doi: 10.4103/sja.SJA_559_18.
- Background: PubMed 34196965Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.
- Background: PubMed 23338004Bell ML, Kenward MG, Fairclough DL, Horton NJ. Differential dropout and bias in randomised controlled trials: when it matters and when it may not. BMJ. 2013 Jan 21;346:e8668. doi: 10.1136/bmj.e8668.
- Individual participant dataSharing planned: Yes. The IPD and results of this study will be presented at national and international orthopedic meetings and will be submitted to highly-ranked peer reviewed orthopedic journals.
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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.
Matthieu Hanauer, M.D. principal investigator
HFR Fribourg - Hôpital cantonal
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 in people with Pain, Postoperative, run by Hôpital Fribourgeois at 1 site in Switzerland.
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 11 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 2 Feb 2024. 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 Switzerland. 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?
Visual analogue scale (VAS) (time frame: Reduction of postoperative pain in the 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?
On the ClinicalTrials.gov record for NCT05056675, which also lists 7 linked publications.
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 2 Feb 2024; AzTrials last refreshed its copy on 29 Oct 2026.