Pain, PostoperativePENGESPNCT05796804
Erector Spinae Block Versus PENG Block for Hip Replacement
A study testing ERECTOR SPINAE PLANE BLOCK, Peng block + lateral femoral cutaneous nerve block and spinal anesthesia in people with Pain, Postoperative, run by Papa Giovanni XXIII Hospital at 1 site in Italy.
Trial summary
THR (Total Hip Replacement) can be very painful and regional anesthesia is very effective in reducing postoperative pain. Erector Spinae Plane Block (ESPB) and PENG (pericapsular nerve group block) are alternative approaches to the hip sensitive nerve branches that resulted to be very promising for hip surgeries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- ERECTOR SPINAE PLANE BLOCK, Peng block + lateral femoral cutaneous nerve block and spinal anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- 13 Apr 2023to 23 May 2024
- 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
- primary total hip replacement
- informed consent
Who cannot join
- allergies to study drugs
- spinal anesthesia contraindicated
- kidney failure
- epilepsy, psychiatric disease, neurologic deficits
- revision surgery
- neuropathies in the lumbar area
Show all 10Show fewer
- no informed consent
- pregnancy
- alcohol/opioid abuse
- emergency surgery/intensive care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erector Spinae Block Versus PENG Block for Postoperative Analgesia After Total Hip Replacement
THR (Total Hip Replacement) can be very painful and regional anesthesia is very effective in reducing postoperative pain. Erector Spinae Plane Block (ESPB) and PENG (pericapsular nerve group block) are alternative approaches to the hip sensitive nerve branches that resulted to be very promising for hip surgeries. However, no studies investigated the analgesic superiority of either PENG or ESPB. In our study the investigators compare PENG (with a lateral femoral cutaneous nerve block) and ESPB in terms of pain relief expressed as morphine consumption in the first 24 hours after primary THR.
- Conditions
- Pain, Postoperative
- Being tested
- ERECTOR SPINAE PLANE BLOCK, Peng block + lateral femoral cutaneous nerve block, spinal 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.
ERECTOR SPINAE PLANE BLOCKProcedure or surgery
ULTRASOUND GUIDED - ROPIVACAINE 30 ml 0.5%
Peng block + lateral femoral cutaneous nerve blockProcedure or surgery
ULTRASOUND GUIDED - ROPIVACAINE 20 ml 0.5% + 10 ml 0.5%
spinal anesthesiaProcedure or surgery
bupivacaine 0.5% 2.2 ml
| Study group | Role | What they receive |
|---|---|---|
| ERECTOR SPINAE PLANE BLOCK | Active comparator | ultrasound guided block at L4 Receives: Procedure: ERECTOR SPINAE PLANE BLOCK; Procedure: spinal anesthesia |
| PERICAPSULARE NERVE GROUP AND LATERAL FEMORAL CUTANEOUS NERVE BLOCK | Active comparator | ultrasound guided block below the ileo-psoas muscle tendon, above the ilio-pectineous eminence and ultrasound guided block of lateral femoral cutaneous nerve Receives: Procedure: Peng block + lateral femoral cutaneous nerve block; Procedure: spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption
milligrams of morphine by patient controlled analgesia intravenously
Measured: 24 hours
Secondary outcomes (4)
postoperative pain
numeric rating scale - NRS 11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"
Measured: 48 hours
neuropathic pain
DN4 questionnaire - 4 items questionnaire to investigate the occurrence of neuropathic component
Measured: 48 hours
postoperative complications
nausea, vomiting, vertigo, blurred vision, syncope, bleeding, falls
Measured: 48 hours
chronic postoperative pain
numeric rating scale 11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start13 Apr 2023
- Primary completion23 Feb 2024
- Study completion23 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papa Giovanni XXIII Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dario Bugada, Papa Giovanni XXIII Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796804
- Sponsor's protocol ID
- 030/23
- Acronym
- PENGESP
- Status last verified
- Jul 2024
- First submitted
- 21 Mar 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Block Versus PENG Block for Postoperative Analgesia After Total Hip Replacement
- ClinicalTrials.gov ID
- NCT05796804
- Acronym / sponsor ID
- PENGESP / 030/23
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Papa Giovanni XXIII HospitalUniversity, hospital or other
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 4 Apr 2023 (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.
THR (Total Hip Replacement) can be very painful and regional anesthesia is very effective in reducing postoperative pain. Erector Spinae Plane Block (ESPB) and PENG (pericapsular nerve group block) are alternative approaches to the hip sensitive nerve branches that resulted to be very promising for hip surgeries. However, no studies investigated the analgesic superiority of either PENG or ESPB. In our study the investigators compare PENG (with a lateral femoral cutaneous nerve block) and ESPB in terms of pain relief expressed as morphine consumption in the first 24 hours after primary THR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERECTOR SPINAE PLANE BLOCK | Active comparator | Procedure: ERECTOR SPINAE PLANE BLOCK, Procedure: spinal anesthesiaultrasound guided block at L4 |
| PERICAPSULARE NERVE GROUP AND LATERAL FEMORAL CUTANEOUS NERVE BLOCK | Active comparator | Procedure: Peng block + lateral femoral cutaneous nerve block, Procedure: spinal anesthesiaultrasound guided block below the ileo-psoas muscle tendon, above the ilio-pectineous eminence and ultrasound guided block of lateral femoral cutaneous nerve |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- primary total hip replacement
- informed consent
Key exclusion criteria (10 listed)
- allergies to study drugs
- spinal anesthesia contraindicated
- kidney failure
- epilepsy, psychiatric disease, neurologic deficits
- revision surgery
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 |
|---|---|---|
| ERECTOR SPINAE PLANE BLOCKULTRASOUND GUIDED - ROPIVACAINE 30 ml 0.5% | Procedure or surgery | ERECTOR SPINAE PLANE BLOCK |
| Peng block + lateral femoral cutaneous nerve blockULTRASOUND GUIDED - ROPIVACAINE 20 ml 0.5% + 10 ml 0.5% | Procedure or surgery | PERICAPSULARE NERVE GROUP AND LATERAL FEMORAL CUTANEOUS NERVE BLOCK |
| spinal anesthesiabupivacaine 0.5% 2.2 ml | Procedure or surgery | ERECTOR SPINAE PLANE BLOCK, PERICAPSULARE NERVE GROUP AND LATERAL FEMORAL CUTANEOUS NERVE BLOCK |
Primary outcome
morphine consumption
Time frame: 24 hours
milligrams of morphine by patient controlled analgesia intravenously
4 secondary outcomes
postoperative pain
Time frame: 48 hours
neuropathic pain
Time frame: 48 hours
postoperative complications
Time frame: 48 hours
chronic postoperative pain
Time frame: 3 months
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 30 Jul 2024.
- 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.
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 ERECTOR SPINAE PLANE BLOCK, Peng block + lateral femoral cutaneous nerve block and spinal anesthesia in people with Pain, Postoperative, run by Papa Giovanni XXIII Hospital 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 10 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 30 Jul 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 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?
morphine consumption (time frame: 24 hours). 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 30 Jul 2024.