Post Operative Pain After Hip ArthroplastyNCT04336059
Pericapsular Nerve Group Block in Hip Arthroplasty
A study testing pericapsular nerve group block in people with Post Operative Pain After Hip Arthroplasty, run by Tanta University at 1 site in Egypt.
Trial summary
Peripheral nerve blocks are becoming increasingly popular for hip surgery anesthesia. Modern regional anesthesia for major hip surgery includes the use of a single shot and continuous epidural or spinal injections, continuous lumbar plexus blockade and continuous peripheral blockade of the femoral nerve (FN), fascia… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Post Operative Pain After Hip Arthroplasty
- What is being tested?
- pericapsular nerve group block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 30 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will involve in the research if they will schedule for unilateral hip arthroplasty (THA) surgery.
- aged more than 50 years of both genders.
- have American society of anesthiologists physical status I-II and III.
Who cannot join
- Revision hip arthroplasty.
- hip arthroplasty. combined with subtrochanteric shortening osteotomy.
- drug allergy.
- regular narcotic use.
- renal \&/ or hepatic impairments.
- coagulopathy disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Peripheral nerve blocks are becoming increasingly popular for hip surgery anesthesia. Modern regional anesthesia for major hip surgery includes the use of a single shot and continuous epidural or spinal injections, continuous lumbar plexus blockade and continuous peripheral blockade of the femoral nerve (FN), fascia iliaca (FI) block, 3-in-1 FN block and sciatic nerve. The use of either single shot or continuous peripheral nerve blocks are becoming increasingly popular.
This study will be conducted to evaluate the effect of ultrasound guided pericapsular nerve group block in hip arthroplasty surgery.
Read the detailed description
Hip joint is richly innervated, and the pain following hip arthroplasty is particularly severe. Effective postoperative analgesic technique especially in an elderly with significant comorbidities is challenging. (1) Peripheral nerve blocks are becoming increasingly popular for hip surgery anesthesia. Modern regional anesthesia for major hip surgery includes the use of a single shot and continuous epidural or spinal injections, continuous lumbar plexus blockade and continuous peripheral blockade of the femoral nerve (FN), fascia iliaca (FI) block, 3-in-1 FN block and sciatic nerve. The use of either single shot or continuous peripheral nerve blocks are becoming increasingly popular. (2) These techniques have shown effective and safe postoperative pain control, resulting in lower opioid consumption, improved earlier rehabilitation and high patient satisfaction. (3) Pericapsular nerve group (PENG) block has been recently recommended by Giron-Arango et al. for use as postoperative analgesia in hip surgeries. It is a new regional anesthesia method based on blocking the articular branches of femoral nerve (FN) and accessory obturator nerve(AON) and obturator nerve in the region between the anterior inferior iliac spine (AIIS) and ilio-pubic eminence (IPE).The anterior capsule is the most richly innervated section of the joint suggesting these nerves should be the main targets for hip analgesia. (4)
- Being tested
- pericapsular nerve group block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pericapsular nerve group blockProcedure or surgery
The regional block will be performed with the patient in the supine position under complete sterile technique. A low frequency curvilinear ultrasound probe will be initially placed in a transverse plane over the anterior inferior iliacspine (AIIS) and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the iliopubic eminance(IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will observed.
A 22-gauge, 80-mm needle will be inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly after local infiltration of the site of the block with 3 ml lidocaine 2%. Following negative aspiration,the normal saline solution will injected in 5-mL increments while observing for adequate fluid spread in this plane.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Other | will receive sham PENG block with normal saline in total volume of 20 ml. Receives: Procedure: pericapsular nerve group block |
| group 2 | Experimental | will receive real PENG block with bupivacaine (0.25%) in total volume of 20 ml. Receives: Procedure: pericapsular nerve group block |
What is being measured
The primary outcome is the main question the study is designed to answer.
first time of rescue analgesia.
first time of rescue morphine analgesia.
Measured: postoperative first day
Secondary outcomes (2)
postoperative morphine consumption
postoperative morphine consumption as rescue analgesia
Measured: postoperative first day
pain score
pain score by numerical rating score
Measured: postoperative first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start1 May 2020
- Primary completion30 Nov 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain After Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tarek abdel hay mostafa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336059
- Sponsor's protocol ID
- hip arthroplasty
- Status last verified
- Dec 2020
- First submitted
- 3 Apr 2020
- Last updated
- 17 Feb 2021
- 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 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pericapsular Nerve Group Block in Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT04336059
- Acronym / sponsor ID
- hip arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 7 Apr 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.
Peripheral nerve blocks are becoming increasingly popular for hip surgery anesthesia. Modern regional anesthesia for major hip surgery includes the use of a single shot and continuous epidural or spinal injections, continuous lumbar plexus blockade and continuous peripheral blockade of the femoral nerve (FN), fascia iliaca (FI) block, 3-in-1 FN block and sciatic nerve. The use of either single shot or continuous peripheral nerve blocks are becoming increasingly popular.
This study will be conducted to evaluate the effect of ultrasound guided pericapsular nerve group block in hip arthroplasty surgery.
Detailed description
Hip joint is richly innervated, and the pain following hip arthroplasty is particularly severe. Effective postoperative analgesic technique especially in an elderly with significant comorbidities is challenging. (1) Peripheral nerve blocks are becoming increasingly popular for hip surgery anesthesia. Modern regional anesthesia for major hip surgery includes the use of a single shot and continuous epidural or spinal injections, continuous lumbar plexus blockade and continuous peripheral blockade of the femoral nerve (FN), fascia iliaca (FI) block, 3-in-1 FN block and sciatic nerve. The use of either single shot or continuous peripheral nerve blocks are becoming increasingly popular. (2) These techniques have shown effective and safe postoperative pain control, resulting in lower opioid consumption, improved earlier rehabilitation and high patient satisfaction. (3) Pericapsular nerve group (PENG) block has been recently recommended by Giron-Arango et al. for use as postoperative analgesia in hip surgeries. It is a new regional anesthesia method based on blocking the articular branches of femoral nerve (FN) and accessory obturator nerve(AON) and obturator nerve in the region between the anterior inferior iliac spine (AIIS) and ilio-pubic eminence (IPE).The anterior capsule is the most richly innervated section of the joint suggesting these nerves should be the main targets for hip analgesia. (4)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Other | Procedure: pericapsular nerve group blockwill receive sham PENG block with normal saline in total volume of 20 ml. |
| group 2 | Experimental | Procedure: pericapsular nerve group blockwill receive real PENG block with bupivacaine (0.25%) in total volume of 20 ml. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients will involve in the research if they will schedule for unilateral hip arthroplasty (THA) surgery.
- aged more than 50 years of both genders.
- have American society of anesthiologists physical status I-II and III.
Key exclusion criteria (6 listed)
- Revision hip arthroplasty.
- hip arthroplasty. combined with subtrochanteric shortening osteotomy.
- drug allergy.
- regular narcotic use.
- renal \&/ or hepatic impairments.
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 |
|---|---|---|
| pericapsular nerve group blockThe regional block will be performed with the patient in the supine position under complete sterile technique. A low frequency curvilinear ultrasound probe will be initially placed in a transverse plane over the anterior inferior iliacspine (AIIS) and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the iliopubic eminance(IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will observed. A 22-gauge, 80-mm needle will be inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly after local infiltration of the site of the block with 3 ml lidocaine 2%. Following negative aspiration,the normal saline solution will injected in 5-mL increments while observing for adequate fluid spread in this plane. | Procedure or surgery | group 1, group 2 |
Primary outcome
first time of rescue analgesia.
Time frame: postoperative first day
first time of rescue morphine analgesia.
2 secondary outcomes
postoperative morphine consumption
Time frame: postoperative first day
pain score
Time frame: postoperative first day
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 17 Feb 2021.
- Individual participant dataSharing planned: No
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 pericapsular nerve group block in people with Post Operative Pain After Hip Arthroplasty, run by Tanta University at 1 site in Egypt.
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 6 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 17 Feb 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 Egypt. 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 time of rescue analgesia. (time frame: postoperative first day). 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 17 Feb 2021; AzTrials last refreshed its copy on 2 Nov 2026.