Postoperative PainNCT04306133
PENG Block Combined to Wound Infiltration for Hip Replacement
A study testing PENG block and Wound Infiltration in people with Postoperative Pain and Analgesia, run by Campus Bio-Medico University at 1 site in Italy.
Trial summary
This study analyze the effect of Pericapsular Nerve Group (PENG) Block combined to wound infiltration for analgesia after elective hip replacement. Half of participants will receive a PENG Block combined with wound infiltration, while the other half will receive wound infiltration alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Analgesia, Hip Arthropathy
- What is being tested?
- PENG block and Wound Infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 9 Mar 2020to 31 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective hip replacement surgery
- ASA physical status score < 4
Who cannot join
- Contraindications to regional anesthesia
- ASA physical status score ≥ 4
- Patient's refusal or inability to sing the informed consent
- Pre-operatively therapy with opioids
- Allergies to any drug provided by the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pericapsular Nerve Group (PENG) Block Combined to Wound Infiltration vs. Wound Infiltration Alone for Postoperative Analgesia After Total Hip Replacement: a Prospective Controlled Trial
This study analyze the effect of Pericapsular Nerve Group (PENG) Block combined to wound infiltration for analgesia after elective hip replacement.
Half of participants will receive a PENG Block combined with wound infiltration, while the other half will receive wound infiltration alone.
- Conditions
- Postoperative Pain, Analgesia, Hip Arthropathy, Acute Pain, Pain, Postoperative Complications
- Being tested
- PENG block, Wound Infiltration
- Keywords
- regional anesthesia, hip surgery, PENG
- Medical subject headings
- Pain, Postoperative, Agnosia, Acute Pain, Pain, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG blockProcedure or surgery
After performing spinal anesthesia, PENG block with 20 mL of 0.375 % Ropivacaine will be executed as described by Giron-Arongo et al with a low frequency curvilinear probe. A 22G 80 mm needle (Stimuplex Ultra 360, Braun ) will be used.
Wound InfiltrationProcedure or surgery
At the end of operation, the surgeon will perform wound infiltration with 20 mL of 0.375 % Ropivacaine.
| Study group | Role | What they receive |
|---|---|---|
| PENG BLOCK AND WOUND INFILTRATION | Experimental | Participants receiving PENG block combined to wound infiltration Receives: Procedure: PENG block; Procedure: Wound Infiltration |
| WOUND INFILTRATION | Active comparator | Participants receiving wound infiltration alone Receives: Procedure: Wound Infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Pain Score
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain during 48 h after surgery
Measured: 24 hours
Total opioids consumption
Total of Sublingual Sufentanil tablets released
Measured: 48 hours
Secondary outcomes (6)
Time to first opioid
Time (hours) from the end of surgery to the first opioid administration
Measured: 48 hours
Range of hip motion
Degrees of hip flexion
Measured: 24 hours
Time to ambulation
Time until the patient is able to stand up and walk with or without assistive devices
Measured: 48 hours
Quadriceps weakness
Presence of weakness of the quadriceps using a scale where 0= no effect; 1 = knee flexion possible but not hip flexion; 2 = absence of knee and hip flexion
Measured: 48 hours
Incidence of block complications
Any complications or side effects of the blocks, such as local infection, intravascular injection of local anesthetics and immediate systemic toxicity.
Measured: 48 hours
Opioids side effects
The presence or absence of opioids side effects such as drowsiness, desaturation, nausea and vomiting
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start9 Mar 2020
- Primary completion24 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Pascarella, Campus Bio-Medico University
- Investigators
- Giuseppe Pascarella, MD, Principal investigator, University Hospital Campus Biomedico of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306133
- Sponsor's protocol ID
- 29/20 PAR ComEt CBM
- Status last verified
- Apr 2021
- First submitted
- 8 Mar 2020
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Short AJ, Barnett JJG, Gofeld M, Baig E, Lam K, Agur AMR, Peng PWH. Anatomic Study of Innervation of the Anterior Hip Capsule: Implication for Image-Guided Intervention. Reg Anesth Pain Med. 2018 Feb;43(2):186-192. doi: 10.1097/AAP.0000000000000701.
PubMed 29140962Giron-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 30063657Pascarella 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 34196965
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pericapsular Nerve Group (PENG) Block Combined to Wound Infiltration vs. Wound Infiltration Alone for Postoperative Analgesia After Total Hip Replacement: a Prospective Controlled Trial
- ClinicalTrials.gov ID
- NCT04306133
- Acronym / sponsor ID
- 29/20 PAR ComEt CBM
- Conditions
- Postoperative Pain, Analgesia, Hip Arthropathy, Acute Pain, Pain, Postoperative Complications
- Keywords
- regional anesthesia, hip surgery, PENG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 24 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 12 Mar 2020 (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 analyze the effect of Pericapsular Nerve Group (PENG) Block combined to wound infiltration for analgesia after elective hip replacement.
Half of participants will receive a PENG Block combined with wound infiltration, while the other half will receive wound infiltration alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENG BLOCK AND WOUND INFILTRATION | Experimental | Procedure: PENG block, Procedure: Wound InfiltrationParticipants receiving PENG block combined to wound infiltration |
| WOUND INFILTRATION | Active comparator | Procedure: Wound InfiltrationParticipants receiving wound infiltration alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective hip replacement surgery
- ASA physical status score < 4
Key exclusion criteria (5 listed)
- Contraindications to regional anesthesia
- ASA physical status score ≥ 4
- Patient's refusal or inability to sing the informed consent
- Pre-operatively therapy with opioids
- Allergies to any drug provided by the study protocol
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 blockAfter performing spinal anesthesia, PENG block with 20 mL of 0.375 % Ropivacaine will be executed as described by Giron-Arongo et al with a low frequency curvilinear probe. A 22G 80 mm needle (Stimuplex Ultra 360, Braun ) will be used. | Procedure or surgery | PENG BLOCK AND WOUND INFILTRATION |
| Wound InfiltrationAt the end of operation, the surgeon will perform wound infiltration with 20 mL of 0.375 % Ropivacaine. | Procedure or surgery | PENG BLOCK AND WOUND INFILTRATION, WOUND INFILTRATION |
Primary outcome
Maximum Pain Score
Time frame: 24 hours
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain during 48 h after surgery
Total opioids consumption
Time frame: 48 hours
Total of Sublingual Sufentanil tablets released
6 secondary outcomes
Time to first opioid
Time frame: 48 hours
Range of hip motion
Time frame: 24 hours
Time to ambulation
Time frame: 48 hours
Quadriceps weakness
Time frame: 48 hours
Incidence of block complications
Time frame: 48 hours
Opioids side effects
Time frame: 48 hours
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 6 Apr 2021.
- Background: PubMed 29140962Short AJ, Barnett JJG, Gofeld M, Baig E, Lam K, Agur AMR, Peng PWH. Anatomic Study of Innervation of the Anterior Hip Capsule: Implication for Image-Guided Intervention. Reg Anesth Pain Med. 2018 Feb;43(2):186-192. doi: 10.1097/AAP.0000000000000701.
- Results publication: 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.
- Derived from this study: 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.
- Individual participant dataSharing planned: No
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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.
Giuseppe Pascarella, MD principal investigator
University Hospital Campus Biomedico of Rome
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 Wound Infiltration in people with Postoperative Pain and Analgesia, run by Campus Bio-Medico University at 1 site in Italy.
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 2 inclusion and 5 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 6 Apr 2021. 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 Italy. 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?
Maximum Pain Score (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 NCT04306133, which also lists 3 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 6 Apr 2021.