Postoperative PainNCT04681222
Comparison of the Efficacy of PENG Block in Combination With LFCN Block and Wound Infiltration
An observational study of Postoperative Pain, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The ultrasound-guided approach for the blockade of articular branches of femoral and obturator nerves, pericapsular nerve group (PENG) block, is an effective method for postoperative analgesia in hip surgeries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- LFCN and Wound infiltration
- Type of treatment
- Surgery or procedure
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 31 Dec 2019
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients underwent total hip arthroplasty with the diagnosis of coxarthrosis, and those received PENG blocks for postoperative analgesia combined with whether LFCN block or wound infiltration.
Who may be able to join
- Coxarthrosis
- Total hip replacement
- Patients agreed to receive PENG block
- LFCN or wound infiltration performed combined with PENG blocks
Who cannot join
- Other kinds of hip surgeries
- Total hip replacement performed for other indications
- Patients refused to receive PENG block
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Derince Training and Research Hospital
Kocaeli, Derince, 41900
About this study
Official title: Postoperative Pain Management in Patients Undergoing Total Hip Arthroplasty: PENG Block in Combination With LFCN Block or Wound Infiltration?
The ultrasound-guided approach for the blockade of articular branches of femoral and obturator nerves, pericapsular nerve group (PENG) block, is an effective method for postoperative analgesia in hip surgeries.
Read the detailed description
The ultrasound-guided approach for the blockade of articular branches of femoral and obturator nerves, pericapsular nerve group (PENG) block, is an effective method for postoperative analgesia in hip surgeries. However, it fails to provide cutaneous analgesia on the anterolateral surgical incisional site. This study compares the effects of wound infiltration and lateral femoral nerve blocks in combination with PENG blocks for postoperative pain in patients undergoing total hip arthroplasty for coxarthrosis.
- Conditions
- Postoperative Pain
- Being tested
- LFCN, Wound infiltration
- Keywords
- Coxarthrosis, Regional Anesthesia, Total Hip Replacement
- Medical subject headings
- Pain, Postoperative, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LFCNProcedure or surgery
LFCN block was performed in combination with PENG block
Wound infiltrationProcedure or surgery
Wound infiltration was performed in combination with PENG block
| Study group | Role | What they receive |
|---|---|---|
| LFCN | Patients received LFCN + PENG blocks Receives: Procedure: LFCN | |
| Wound Infiltration | Patients received wound infiltration + PENG blocks Receives: Procedure: Wound infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
First analgesic demand
The time interval from PENG blocks to the first analgesic demand.
Measured: 24 hours
Secondary outcomes (3)
Opioid consumption
Total opioid analgesic consumption
Measured: 24 hours
Numeric Rating Scale
The maximum score on a 10cm numeric rating scale: (0 to 10cm) (0 = no pain, 10 = worst imaginable pain)
Measured: 24 hours
Nonsteroidal Anti-inflammatory Drugs (NSAID)
Total NSAID consumption
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derince Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bursa Yuksek Ihtisas Training and Research Hospital
- Responsible party
- Principal investigator, Hande Gurbuz, Derince Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681222
- Sponsor's protocol ID
- U1111-1262-9877
- Status last verified
- Dec 2020
- First submitted
- 18 Dec 2020
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Giron-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 30063657Roy R, Agarwal G, Pradhan C, Kuanar D. Total postoperative analgesia for hip surgeries, PENG block with LFCN block. Reg Anesth Pain Med. 2019 Mar 28:rapm-2019-100454. doi: 10.1136/rapm-2019-100454. Online ahead of print. No abstract available.
PubMed 30923252Nersesjan M, Hagi-Pedersen D, Andersen JH, Mathiesen O, Dahl JB, Broeng L, Thybo KH. Sensory distribution of the lateral femoral cutaneous nerve block - a randomised, blinded trial. Acta Anaesthesiol Scand. 2018 Jul;62(6):863-873. doi: 10.1111/aas.13091. Epub 2018 Feb 21.
PubMed 29468642Giron-Arango L, Roques V, Peng P. Reply To Dr Roy et al: Total postoperative analgesia for hip surgeries: PENG block with LFCN block. Reg Anesth Pain Med. 2019 Mar 28:rapm-2019-100505. doi: 10.1136/rapm-2019-100505. Online ahead of print. No abstract available.
PubMed 30923249Mistry T, Sonawane KB, Kuppusamy E. PENG block: points to ponder. Reg Anesth Pain Med. 2019 Mar;44(3):423-424. doi: 10.1136/rapm-2018-100327. Epub 2019 Jan 11. No abstract available.
PubMed 30635514
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Management in Patients Undergoing Total Hip Arthroplasty: PENG Block in Combination With LFCN Block or Wound Infiltration?
- ClinicalTrials.gov ID
- NCT04681222
- Acronym / sponsor ID
- U1111-1262-9877
- Conditions
- Postoperative Pain
- Keywords
- Coxarthrosis, Regional Anesthesia, Total Hip Replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Collaborators
- Bursa Yuksek Ihtisas Training and Research Hospital
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 23 Dec 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.
The ultrasound-guided approach for the blockade of articular branches of femoral and obturator nerves, pericapsular nerve group (PENG) block, is an effective method for postoperative analgesia in hip surgeries.
Detailed description
The ultrasound-guided approach for the blockade of articular branches of femoral and obturator nerves, pericapsular nerve group (PENG) block, is an effective method for postoperative analgesia in hip surgeries. However, it fails to provide cutaneous analgesia on the anterolateral surgical incisional site. This study compares the effects of wound infiltration and lateral femoral nerve blocks in combination with PENG blocks for postoperative pain in patients undergoing total hip arthroplasty for coxarthrosis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LFCN | – | Procedure: LFCNPatients received LFCN + PENG blocks |
| Wound Infiltration | – | Procedure: Wound infiltrationPatients received wound infiltration + PENG blocks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients underwent total hip arthroplasty with the diagnosis of coxarthrosis, and those received PENG blocks for postoperative analgesia combined with whether LFCN block or wound infiltration.
Key inclusion criteria (4 listed)
- Coxarthrosis
- Total hip replacement
- Patients agreed to receive PENG block
- LFCN or wound infiltration performed combined with PENG blocks
Key exclusion criteria (3 listed)
- Other kinds of hip surgeries
- Total hip replacement performed for other indications
- Patients refused to receive PENG block
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 |
|---|---|---|
| LFCNLFCN block was performed in combination with PENG block | Procedure or surgery | LFCN |
| Wound infiltrationWound infiltration was performed in combination with PENG block | Procedure or surgery | Wound Infiltration |
Primary outcome
First analgesic demand
Time frame: 24 hours
The time interval from PENG blocks to the first analgesic demand.
3 secondary outcomes
Opioid consumption
Time frame: 24 hours
Numeric Rating Scale
Time frame: 24 hours
Nonsteroidal Anti-inflammatory Drugs (NSAID)
Time frame: 24 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 24 Dec 2020.
- 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 30923252Roy R, Agarwal G, Pradhan C, Kuanar D. Total postoperative analgesia for hip surgeries, PENG block with LFCN block. Reg Anesth Pain Med. 2019 Mar 28:rapm-2019-100454. doi: 10.1136/rapm-2019-100454. Online ahead of print. No abstract available.
- Background: PubMed 29468642Nersesjan M, Hagi-Pedersen D, Andersen JH, Mathiesen O, Dahl JB, Broeng L, Thybo KH. Sensory distribution of the lateral femoral cutaneous nerve block - a randomised, blinded trial. Acta Anaesthesiol Scand. 2018 Jul;62(6):863-873. doi: 10.1111/aas.13091. Epub 2018 Feb 21.
- Background: PubMed 30923249Giron-Arango L, Roques V, Peng P. Reply To Dr Roy et al: Total postoperative analgesia for hip surgeries: PENG block with LFCN block. Reg Anesth Pain Med. 2019 Mar 28:rapm-2019-100505. doi: 10.1136/rapm-2019-100505. Online ahead of print. No abstract available.
- Background: PubMed 30635514Mistry T, Sonawane KB, Kuppusamy E. PENG block: points to ponder. Reg Anesth Pain Med. 2019 Mar;44(3):423-424. doi: 10.1136/rapm-2018-100327. Epub 2019 Jan 11. No abstract available.
- Individual participant dataSharing planned: Undecided
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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?
An observational study of Postoperative Pain, run by Derince Training and Research Hospital 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 3 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 24 Dec 2020. 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?
First analgesic demand (time frame: 24 hours). 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 NCT04681222, which also lists 5 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 24 Dec 2020.