Post Operative PainPENGNCT05932498
Peri-capsular Nerve Group (PENG) Block and Quadratus Lumborum Block for Hip Arthroplasty
A study testing Hip surgery in people with Post Operative Pain, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
The goal of this randomized controlled clinical trial is to compare peri-capsular nerve group (PENG) block and quadratus lumborum (QL) block in participants who receive hip arthroplasty. The main question aims to answer is comparing the pain score among participants who receive PENG or QL block. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Hip surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Jan 2020to 31 Jan 2021
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are 20 years of age or older (including 20 years of age).
- Non-emergency hip arthroplasty surgery.
- Able to understand and cooperate with preoperative and postoperative data collection.
- Grade one to three in the American Society of Anesthesiologists (ASA) physical status classification.
Who cannot join
- Under 20 years of age.
- A known allergy to the study medication (ropivacaine).
- Liver cirrhosis classified as Child Pugh Score C.
- Dementia or mental illness.
- Unable to assess their own pain level.
- Patients who have been using opioid drugs for a prolonged period.
- Having a history of drug or alcohol abuse within the last 6 months.
- Having serious illness and at a risk of imminent mortality.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peri-capsular Nerve Group Block and Quadratus Lumborum Block for Hip Arthroplasty: A Randomized Controlled Trial
The goal of this randomized controlled clinical trial is to compare peri-capsular nerve group (PENG) block and quadratus lumborum (QL) block in participants who receive hip arthroplasty. The main question aims to answer is comparing the pain score among participants who receive PENG or QL block.
Participants will be randomized and assigned into two groups. Participants will receive a PENG block in the PENG group and receive a QL block in the QL group. After participants receive hip arthroplasty, the investigators will compare the two groups to see if there is a difference of pain score, postoperative opioid consumption, sensation and motor function after nerve blocks, progress of functional recovery in lower limbs, intraoperative and postoperative complications.
Read the detailed description
Hip joint surgery is a common orthopedic procedure that effectively improves patients' quality of life and functional status. However, postoperative pain is a common issue that can affect patients' activity, increase the risk of venous thromboembolism due to venous stasis, and prolong recovery time, hospital stay, and expenses. Therefore, controlling postoperative pain after hip joint surgery is crucial to reduce its side effects. Nerve block is one of the methods for postoperative pain management after hip joint surgery and has been proven effective in reducing pain levels, decreasing opioid use, and its side effects.
Traditionally, the quadratus lumborum nerve block (QL block) is used for pain relief during abdominal surgery, but it can also be used for lower limb surgery due to its extensive application. Compared to other nerve blocks, QL block may provide better postoperative pain relief, have less impact on hip joint activity and quadriceps muscle contraction, and reduce opioid use and hospital stay.
The peri-capsular nerve group block (PENG block) is another nerve block technique performed by injecting anesthetic analgesics around the hip joint capsule using ultrasound and blocking surrounding nerves with a larger dose. In a clinical study, PENG block significantly reduced static and dynamic pain scores in five patients with femoral neck fractures after 30 minutes of the nerve block. PENG block has advantages in injection and identification of anatomical structures compared to QL block, but their analgesic effects have not been directly compared. Therefore, clinical trials of both techniques are needed.
- Conditions
- Post Operative Pain
- Being tested
- Hip surgery
- Keywords
- postoperative pain, nerve block, regional analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip surgeryProcedure or surgery
Ultrasound-guided PENG block was administered to patients undergoing hip surgery intraoperatively.
OR
Ultrasound-guided QL block was administered to patients undergoing hip surgery intraoperatively.
| Study group | Role | What they receive |
|---|---|---|
| PENG group | Experimental | Participants with PENG block Receives: Procedure: Hip surgery |
| QL group | Active comparator | Participants with QL block Receives: Procedure: Hip surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing pain scores between the PENG and QL groups immediately after surgery
Pain scores were assessed using a standard Visual Analog Scale (VAS), where a rating of 0 indicated the absence of pain, while a score of 10 denoted the presence of the most severe pain.
Measured: 10 minutes after surgery
Comparing pain scores between the PENG and QL groups at the 1-hour postoperative mark
Pain scores were assessed using a standard Visual Analog Scale (VAS), where a rating of 0 indicated the absence of pain, while a score of 10 denoted the presence of the most severe pain.
Measured: at the 1-hour postoperative mark
Comparing pain scores between the PENG and QL groups at the 12-hour postoperative mark
Pain scores were assessed using a standard Visual Analog Scale (VAS), where a rating of 0 indicated the absence of pain, while a score of 10 denoted the presence of the most severe pain.
Measured: at the 12-hour postoperative mark
Comparing pain scores between the PENG and QL groups at the 24-hour postoperative mark
Pain scores were assessed using a standard Visual Analog Scale (VAS), where a rating of 0 indicated the absence of pain, while a score of 10 denoted the presence of the most severe pain.
Measured: at the 24-hour postoperative mark
Comparing pain scores between the PENG and QL groups at the 48-hour postoperative mark
Pain scores were assessed using a standard Visual Analog Scale (VAS), where a rating of 0 indicated the absence of pain, while a score of 10 denoted the presence of the most severe pain.
Measured: at the 48-hour postoperative mark
Secondary outcomes (6)
Postoperative opioid consumption
Comparing the amount of parenteral opioids administered for rescue purposes as Morphine Milligram Equivalents (MME) between the PENG and QL groups at various postoperative time intervals.
Measured: at the 12-, 24-, 48-hours after surgery
The quadriceps strength on surgical side
After performing PENG or QL blocks, the investigators assessed and compared the strength of the quadriceps muscles on the side that underwent hip surgery using Manual Muscle Testing (MMT) scores. MMT involves assigning scores to assess the patients' quadriceps muscle strength, ranging from 0 (no activation) to 5 (activation against resistance).
Measured: at the 0-, 1-, 12-, 24-, 48-, and 72-hours after surgery
Time to independently sit at the edge of the bed after surgery
Sitting at the edge of the bed is a functional milestone that reflects the patient's progress toward regaining mobility and independence in activities of daily living.
The duration required to achieve sitting at the edge of the bed was measured in terms of the number of days following the surgery.
Measured: From the date of hip surgery until the patient achieves independent sitting at the edge of the bed, with a maximum follow-up period of 7 days
Time to stand up after surgery
Standing up indicates the patient's ability to bear weight on the affected hip joint and engage in activities such as walking, transferring, and performing daily tasks after hip surgery.
The duration required to achieve standing up was measured in terms of the number of days following the surgery.
Measured: From the date of hip surgery until the patient achieves standing up, with a maximum follow-up period of 7 days
Time to walk with the aid of walking devices after surgery
Walking with the aid of walking devices reflects the patient's ability to regain mobility and independence in walking, even if patients require assistance or support from these devices.
The duration required to achieve walking with the aid of walking devices was measured in terms of the number of days following the surgery.
Measured: From the date of hip surgery until the patient achieves walking with the aid of walking devices, with a maximum follow-up period of 7 days
Perioperative blood loss and blood transfusion
The investigators documented the amount of blood loss and the need for blood transfusion both during the surgery and in the postoperative period.
Measured: During the surgery and over the three-day postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start6 Jan 2020
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post Operative 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
- Model description
- one group is that participants receive PENG block and another group is that participants receive QL block for postoperative pain control.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Po-Kai Wang, Hualien Tzu Chi General Hospital
- Investigators
- Po-Kai Wang, MD, PhD, Principal investigator, Hualien Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932498
- Sponsor's protocol ID
- IRB108-235-A
- Acronym
- PENG
- Status last verified
- Jul 2023
- First submitted
- 7 May 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Min BW, Kim Y, Cho HM, Park KS, Yoon PW, Nho JH, Kim SM, Lee KJ, Moon KH. Perioperative Pain Management in Total Hip Arthroplasty: Korean Hip Society Guidelines. Hip Pelvis. 2016 Mar;28(1):15-23. doi: 10.5371/hp.2016.28.1.15. Epub 2016 Mar 31.
PubMed 27536639Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
PubMed 28154824La Colla L, Ben-David B, Merman R. Quadratus Lumborum Block as an Alternative to Lumbar Plexus Block for Hip Surgery: A Report of 2 Cases. A A Case Rep. 2017 Jan 1;8(1):4-6. doi: 10.1213/XAA.0000000000000406.
PubMed 28036319Giron-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 30063657
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-capsular Nerve Group Block and Quadratus Lumborum Block for Hip Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05932498
- Acronym / sponsor ID
- PENG / IRB108-235-A
- Conditions
- Post Operative Pain
- Keywords
- postoperative pain, nerve block, regional analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 6 Jul 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 goal of this randomized controlled clinical trial is to compare peri-capsular nerve group (PENG) block and quadratus lumborum (QL) block in participants who receive hip arthroplasty. The main question aims to answer is comparing the pain score among participants who receive PENG or QL block.
Participants will be randomized and assigned into two groups. Participants will receive a PENG block in the PENG group and receive a QL block in the QL group. After participants receive hip arthroplasty, the investigators will compare the two groups to see if there is a difference of pain score, postoperative opioid consumption, sensation and motor function after nerve blocks, progress of functional recovery in lower limbs, intraoperative and postoperative complications.
Detailed description
Hip joint surgery is a common orthopedic procedure that effectively improves patients' quality of life and functional status. However, postoperative pain is a common issue that can affect patients' activity, increase the risk of venous thromboembolism due to venous stasis, and prolong recovery time, hospital stay, and expenses. Therefore, controlling postoperative pain after hip joint surgery is crucial to reduce its side effects. Nerve block is one of the methods for postoperative pain management after hip joint surgery and has been proven effective in reducing pain levels, decreasing opioid use, and its side effects.
Traditionally, the quadratus lumborum nerve block (QL block) is used for pain relief during abdominal surgery, but it can also be used for lower limb surgery due to its extensive application. Compared to other nerve blocks, QL block may provide better postoperative pain relief, have less impact on hip joint activity and quadriceps muscle contraction, and reduce opioid use and hospital stay.
The peri-capsular nerve group block (PENG block) is another nerve block technique performed by injecting anesthetic analgesics around the hip joint capsule using ultrasound and blocking surrounding nerves with a larger dose. In a clinical study, PENG block significantly reduced static and dynamic pain scores in five patients with femoral neck fractures after 30 minutes of the nerve block. PENG block has advantages in injection and identification of anatomical structures compared to QL block, but their analgesic effects have not been directly compared. Therefore, clinical trials of both techniques are needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- one group is that participants receive PENG block and another group is that participants receive QL block for postoperative pain control.
| Arm | Type | Receives |
|---|---|---|
| PENG group | Experimental | Procedure: Hip surgeryParticipants with PENG block |
| QL group | Active comparator | Procedure: Hip surgeryParticipants with QL block |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are 20 years of age or older (including 20 years of age).
- Non-emergency hip arthroplasty surgery.
- Able to understand and cooperate with preoperative and postoperative data collection.
- Grade one to three in the American Society of Anesthesiologists (ASA) physical status classification.
Key exclusion criteria (8 listed)
- Under 20 years of age.
- A known allergy to the study medication (ropivacaine).
- Liver cirrhosis classified as Child Pugh Score C.
- Dementia or mental illness.
- Unable to assess their own pain level.
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 |
|---|---|---|
| Hip surgeryUltrasound-guided PENG block was administered to patients undergoing hip surgery intraoperatively. OR Ultrasound-guided QL block was administered to patients undergoing hip surgery intraoperatively. | Procedure or surgery | PENG group, QL group |
Primary outcome
Comparing pain scores between the PENG and QL groups immediately after surgery
Time frame: 10 minutes after surgery
Pain scores were assessed using a standard Visual Analog Scale (VAS), where a rating of 0 indicated the absence of pain, while a score of 10 denoted the presence of the most severe pain.
Comparing pain scores between the PENG and QL groups at the 1-hour postoperative mark
Time frame: at the 1-hour postoperative mark
Pain scores were assessed using a standard Visual Analog Scale (VAS), where a rating of 0 indicated the absence of pain, while a score of 10 denoted the presence of the most severe pain.
Comparing pain scores between the PENG and QL groups at the 12-hour postoperative mark
Time frame: at the 12-hour postoperative mark
Pain scores were assessed using a standard Visual Analog Scale (VAS), where a rating of 0 indicated the absence of pain, while a score of 10 denoted the presence of the most severe pain.
Comparing pain scores between the PENG and QL groups at the 24-hour postoperative mark
Time frame: at the 24-hour postoperative mark
Pain scores were assessed using a standard Visual Analog Scale (VAS), where a rating of 0 indicated the absence of pain, while a score of 10 denoted the presence of the most severe pain.
Comparing pain scores between the PENG and QL groups at the 48-hour postoperative mark
Time frame: at the 48-hour postoperative mark
Pain scores were assessed using a standard Visual Analog Scale (VAS), where a rating of 0 indicated the absence of pain, while a score of 10 denoted the presence of the most severe pain.
6 secondary outcomes
Postoperative opioid consumption
Time frame: at the 12-, 24-, 48-hours after surgery
The quadriceps strength on surgical side
Time frame: at the 0-, 1-, 12-, 24-, 48-, and 72-hours after surgery
Time to independently sit at the edge of the bed after surgery
Time frame: From the date of hip surgery until the patient achieves independent sitting at the edge of the bed, with a maximum follow-up period of 7 days
Time to stand up after surgery
Time frame: From the date of hip surgery until the patient achieves standing up, with a maximum follow-up period of 7 days
Time to walk with the aid of walking devices after surgery
Time frame: From the date of hip surgery until the patient achieves walking with the aid of walking devices, with a maximum follow-up period of 7 days
Perioperative blood loss and blood transfusion
Time frame: During the surgery and over the three-day postoperative period
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 Jul 2023.
- Background: PubMed 27536639Min BW, Kim Y, Cho HM, Park KS, Yoon PW, Nho JH, Kim SM, Lee KJ, Moon KH. Perioperative Pain Management in Total Hip Arthroplasty: Korean Hip Society Guidelines. Hip Pelvis. 2016 Mar;28(1):15-23. doi: 10.5371/hp.2016.28.1.15. Epub 2016 Mar 31.
- Background: PubMed 28154824Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
- Background: PubMed 28036319La Colla L, Ben-David B, Merman R. Quadratus Lumborum Block as an Alternative to Lumbar Plexus Block for Hip Surgery: A Report of 2 Cases. A A Case Rep. 2017 Jan 1;8(1):4-6. doi: 10.1213/XAA.0000000000000406.
- 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.
- 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.
Po-Kai Wang, MD, PhD principal investigator
Hualien Tzu Chi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip surgery in people with Post Operative Pain, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
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 8 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 Jul 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 Taiwan. 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?
Comparing pain scores between the PENG and QL groups immediately after surgery (time frame: 10 minutes after surgery). The study lists 5 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 NCT05932498, which also lists 4 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 Jul 2023.