Pain, PostoperativeNCT05802589
Comparison of the Efficiency of PENG Block and ESP Block Used for Postoperative Analgesia in Elective Hip Surgery
A study testing Lumbar Erector Spinae Plane Block, Pericapsular Nerve Group Block and no peripheral block in people with Pain, Postoperative and Anesthesia, Regional, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to determine whether the traditional intravenous analgesia technique or the ultrasound-guided pericapsular nerve group block or the unilateral erector spina plane block technique is superior in postoperative analgesia management in the hip operation procedure that requires preoperative and… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Pain, Postoperative, Anesthesia, Regional, Hip Surgery
- What is being tested?
- Lumbar Erector Spinae Plane Block, Pericapsular Nerve Group Block and no peripheral block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 May 2021to 1 Jun 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective hip or proximal femoral surgery
- 18-89 years old
- Patients with the American Society of Anesthesiology physical condition classification score (ASA) I-III
Who cannot join
- Patients who do not agree to consent
- Patients who requested to be excluded from the study
- Patients allergic to local anesthetics
- Those with infection at the intervention site
- Those who weigh <30 kg
- Those aged <18 years
Show all 11Show fewer
- Those with an ASA physical condition of 4 or higher
- People with dementia or cognitive impairment
- Patients with bleeding diathesis pathology
- Patients using chronic opioids or corticosteroids
- Patients whose surgical procedure takes <60 minutes or >180 minutes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficiency of Pericapsular Nerve Group Block and Unilateral Lumbar Erector Spina Plan Block Used for Postoperative Analgesia in Elective Hip Surgery: A Prospective Randomized Feasibility Study
The aim of the study is to determine whether the traditional intravenous analgesia technique or the ultrasound-guided pericapsular nerve group block or the unilateral erector spina plane block technique is superior in postoperative analgesia management in the hip operation procedure that requires preoperative and postoperative severe analgesia. In this way, by preventing the health problems that may occur due to the pain of the patients after the operation; to provide benefits for the early mobilization of patients, shortening the hospital stay, reducing the cost and increasing patient satisfaction.
Read the detailed description
Hip arthroplasty (HA) is one of the most successful orthopedic procedures applied today to improve the patient's functional status and quality of life. In patients with hip pain due to various conditions, HA can relieve pain, restore function, and improve quality of life. In the USA alone, approximately 500,000 HA is performed each year. With the increase in the elderly population, HA surgeries have also increased, but despite the developing methods, a gold standard has not been determined for anesthesia and analgesia methods. Appropriate pain management for surgical patients contributes to early mobilization, shortened hospital stay, reduced cost and increased patient satisfaction, while inadequate treatment of pain has detrimental short- or long-term health effects. Therefore, minimizing postoperative pain has become more important for healthcare providers in recent years. Therefore, postoperative pain control can be achieved with balanced and effective analgesia. For this purpose, various analgesia techniques have been used to prevent postoperative pain. The superiority of the techniques to each other varies according to the type of surgery and the combination of techniques applied. Opioids, which are the most widely used to prevent inadequate pain treatment leading to various comorbidities, cause pharmacodynamic results due to physiological changes and serious side effects due to concomitant diseases in patients. In recent years, peripheral nerve blocks have been used in the management of postoperative pain in hip surgeries. Erector spina plane block and pericapsular nerve group block are the most reliable and proven blocks used in hip operations.
The aim of the study is to determine whether traditional intravenous analgesia technique, ultrasound-guided pericapsular nerve group block or unilateral erector spina plane block technique is superior in postoperative analgesia management in hip operation procedure requiring preoperative and postoperative severe analgesia.
- Being tested
- Lumbar Erector Spinae Plane Block, Pericapsular Nerve Group Block, no peripheral block
- Keywords
- Hip Surgery, Pericapsular Nerve Group Block, Lumbar Erector Spinae Plane Block, Regional Anesthesia, Ultrasound-Guided
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Erector Spinae Plane BlockProcedure or surgery
Erector spinae plane block was applied with a 22G/80 mm block needle (Stimuplex A, Braun, Melsungen, Germany) using in-plane technique using a convex USG transducer from the 4th lumbar vertebral level.
Pericapsular Nerve Group BlockProcedure or surgery
Pericapsular nerve group block was performed using a 22G/80 mm block needle (Stimuplex A, Braun, Melsungen, Germany) and a convex USG transducer using an in-plane technique under the iliopsoas muscle in the plane between the iliopsoas tendon and the periosteum and between the anterior inferior iliac spine and the iliopubic eminence.
no peripheral blockProcedure or surgery
No peripheral block was applied. Standard multimodal analgesia method was applied.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (no peripheral block applied) | Active comparator | No peripheral block was applied to this group and it was accepted as the control group. Standard multimodal analgesia and rescue analgesia according to NRS score were applied to each group. Receives: Procedure: no peripheral block |
| Lumbar Erector Spinae Plane Block (L-ESPB) Group | Active comparator | Lumbar erector spinae plane block was applied to this group under ultrasound guidance. Standard multimodal analgesia and rescue analgesia according to NRS score were applied to each group. Receives: Procedure: Lumbar Erector Spinae Plane Block |
| Pericapsular Nerve Group Block (PENGB) Group | Active comparator | Pericapsular nerve group block was applied to this group under ultrasound guidance. Standard multimodal analgesia and rescue analgesia according to NRS score were applied to each group. Receives: Procedure: Pericapsular Nerve Group Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS)
NRS was used to assess postoperative pain. The NRS is a segmented numerical version of the visual analog scale (VAS), in which the respondent chooses an integer (0-10 integer) that best reflects the intensity of his pain. It is considered a one-dimensional measure of pain intensity in adults. It is an 11-point numerical scale. It ranges from "0" representing no pain to "10" representing extreme pain.
Measured: postoperative 24 hours score change
Secondary outcomes (2)
Additional Analgesia
Analgesic drugs administered in the first 24 hours in addition to the routine multimodal analgesia procedure were recorded.
Measured: postoperative 24 hours additional analgesic drug administration
5-point likert satisfaction scale
The patient's satisfaction with postoperative pain treatment will be recorded. 5 options; very dissatisfied, dissatisfied, neither dissatisfied or satisfied, satisfied, very satisfied
Measured: postoperative 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start17 May 2021
- Primary completion31 Dec 2022
- Study completion1 Jun 2023
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was designed as a randomized, double-blind, prospective efficacy study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Kucuk, Trakya University
- Investigators
- ONUR KÜÇÜK, specialist, Principal investigator, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802589
- Sponsor's protocol ID
- TÜTF-BAEK 2021/225
- Status last verified
- Jun 2023
- First submitted
- 25 Mar 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficiency of Pericapsular Nerve Group Block and Unilateral Lumbar Erector Spina Plan Block Used for Postoperative Analgesia in Elective Hip Surgery: A Prospective Randomized Feasibility Study
- ClinicalTrials.gov ID
- NCT05802589
- Acronym / sponsor ID
- TÜTF-BAEK 2021/225
- Keywords
- Hip Surgery, Pericapsular Nerve Group Block, Lumbar Erector Spinae Plane Block, Regional Anesthesia, Ultrasound-Guided
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 6 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.
The aim of the study is to determine whether the traditional intravenous analgesia technique or the ultrasound-guided pericapsular nerve group block or the unilateral erector spina plane block technique is superior in postoperative analgesia management in the hip operation procedure that requires preoperative and postoperative severe analgesia. In this way, by preventing the health problems that may occur due to the pain of the patients after the operation; to provide benefits for the early mobilization of patients, shortening the hospital stay, reducing the cost and increasing patient satisfaction.
Detailed description
Hip arthroplasty (HA) is one of the most successful orthopedic procedures applied today to improve the patient's functional status and quality of life. In patients with hip pain due to various conditions, HA can relieve pain, restore function, and improve quality of life. In the USA alone, approximately 500,000 HA is performed each year. With the increase in the elderly population, HA surgeries have also increased, but despite the developing methods, a gold standard has not been determined for anesthesia and analgesia methods. Appropriate pain management for surgical patients contributes to early mobilization, shortened hospital stay, reduced cost and increased patient satisfaction, while inadequate treatment of pain has detrimental short- or long-term health effects. Therefore, minimizing postoperative pain has become more important for healthcare providers in recent years. Therefore, postoperative pain control can be achieved with balanced and effective analgesia. For this purpose, various analgesia techniques have been used to prevent postoperative pain. The superiority of the techniques to each other varies according to the type of surgery and the combination of techniques applied. Opioids, which are the most widely used to prevent inadequate pain treatment leading to various comorbidities, cause pharmacodynamic results due to physiological changes and serious side effects due to concomitant diseases in patients. In recent years, peripheral nerve blocks have been used in the management of postoperative pain in hip surgeries. Erector spina plane block and pericapsular nerve group block are the most reliable and proven blocks used in hip operations.
The aim of the study is to determine whether traditional intravenous analgesia technique, ultrasound-guided pericapsular nerve group block or unilateral erector spina plane block technique is superior in postoperative analgesia management in hip operation procedure requiring preoperative and postoperative severe analgesia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This study was designed as a randomized, double-blind, prospective efficacy study.
| Arm | Type | Receives |
|---|---|---|
| Control Group (no peripheral block applied) | Active comparator | Procedure: no peripheral blockNo peripheral block was applied to this group and it was accepted as the control group. Standard multimodal analgesia and rescue analgesia according to NRS score were applied to each group. |
| Lumbar Erector Spinae Plane Block (L-ESPB) Group | Active comparator | Procedure: Lumbar Erector Spinae Plane BlockLumbar erector spinae plane block was applied to this group under ultrasound guidance. Standard multimodal analgesia and rescue analgesia according to NRS score were applied to each group. |
| Pericapsular Nerve Group Block (PENGB) Group | Active comparator | Procedure: Pericapsular Nerve Group BlockPericapsular nerve group block was applied to this group under ultrasound guidance. Standard multimodal analgesia and rescue analgesia according to NRS score were applied to each group. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing elective hip or proximal femoral surgery
- 18-89 years old
- Patients with the American Society of Anesthesiology physical condition classification score (ASA) I-III
Key exclusion criteria (11 listed)
- Patients who do not agree to consent
- Patients who requested to be excluded from the study
- Patients allergic to local anesthetics
- Those with infection at the intervention site
- Those who weigh <30 kg
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 |
|---|---|---|
| Lumbar Erector Spinae Plane BlockErector spinae plane block was applied with a 22G/80 mm block needle (Stimuplex A, Braun, Melsungen, Germany) using in-plane technique using a convex USG transducer from the 4th lumbar vertebral level. | Procedure or surgery | Lumbar Erector Spinae Plane Block (L-ESPB) Group |
| Pericapsular Nerve Group BlockPericapsular nerve group block was performed using a 22G/80 mm block needle (Stimuplex A, Braun, Melsungen, Germany) and a convex USG transducer using an in-plane technique under the iliopsoas muscle in the plane between the iliopsoas tendon and the periosteum and between the anterior inferior iliac spine and the iliopubic eminence. | Procedure or surgery | Pericapsular Nerve Group Block (PENGB) Group |
| no peripheral blockNo peripheral block was applied. Standard multimodal analgesia method was applied. | Procedure or surgery | Control Group (no peripheral block applied) |
Primary outcome
Numerical Rating Scale (NRS)
Time frame: postoperative 24 hours score change
NRS was used to assess postoperative pain. The NRS is a segmented numerical version of the visual analog scale (VAS), in which the respondent chooses an integer (0-10 integer) that best reflects the intensity of his pain. It is considered a one-dimensional measure of pain intensity in adults. It is an 11-point numerical scale. It ranges from "0" representing no pain to "10" representing extreme pain.
2 secondary outcomes
Additional Analgesia
Time frame: postoperative 24 hours additional analgesic drug administration
5-point likert satisfaction scale
Time frame: postoperative 24th hour
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 18 Jun 2023.
- 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.
ONUR KÜÇÜK, specialist principal investigator
Trakya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar Erector Spinae Plane Block, Pericapsular Nerve Group Block and no peripheral block in people with Pain, Postoperative and Anesthesia, Regional, run by Trakya 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 3 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 18 Jun 2023. 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?
Numerical Rating Scale (NRS) (time frame: postoperative 24 hours score change). 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 18 Jun 2023.