Pericapsular NerveNCT06904703
Pericapsular Nerve Group and Lumbar Erector Spinae Plane Blocks for Geriatrics Undergoing Total Hip Arthroplasty
A study testing General anesthesia and Bupivacaine 0.5% in people with Pericapsular Nerve and Lumbar Erector Spinae Plane Blocks, run by Tanta University at 1 site in Egypt.
Trial summary
This study will be conducted to evaluate the effect of pericapsular nerve group and erector spinae plane block as adjuvants to general anesthesia in geriatrics undergoing total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Pericapsular Nerve, Lumbar Erector Spinae Plane Blocks, Geriatrics
- What is being tested?
- General anesthesia and Bupivacaine 0.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 1 Nov 2026
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged >75 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) classification I-III.
- Undergoing total hip arthroplasty under general anesthesia.
Who cannot join
- Patient refusal.
- Body mass index (BMI) > 30 kg/m2.
- Allergy to local anesthesia drugs.
- Infection at the site of intervention.
- Coagulopathies.
- Preexisting advanced diseases of the kidney or liver.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combination of Pericapsular Nerve Group and Lumbar Erector Spinae Plane Blocks for Geriatrics Undergoing Total Hip Arthroplasty Under General Anesthesia: A Randomized Controlled Trial
This study will be conducted to evaluate the effect of pericapsular nerve group and erector spinae plane block as adjuvants to general anesthesia in geriatrics undergoing total hip arthroplasty.
Read the detailed description
Total hip arthroplasty is one of the most common major orthopedic procedures to improve a patient's functional status and quality of life. Total hip arthroplasty is one of the most cost-effective and consistently successful surgeries performed in orthopedics and can be associated with significant postoperative pain.
General anesthesia may be considered more versatile and suitable for patients with complex medical histories or those who cannot tolerate spinal anesthesia. However, older patients undergoing hip fracture surgery under general anesthesia may experience a higher risk of postoperative delirium, prolonged sedation, and respiratory complications. Moreover, delayed mobilization is possible, leading to a higher incidence of complications such as deep vein thrombosis and pressure sores.
The target nerves of the hip joint arise from the lumbar plexus (L1-L4), the lumbosacral trunk of the sacral plexus (L4-L5), and the sacral spinal nerves (S1-S4) (7). The femoral nerve, obturator nerve, and the accessory obturator nerve supply the anterior capsule of the hip; the sciatic nerve and the nerve to the quadratus femoris mostly supply the articular branches to the posterior capsule of the hip joint The erector spinae plane block is a novel inter-fascial plane block targets the dorsal and ventral rami of the spinal nerves, is a newer regional anesthetic technique that can be used to provide analgesia for a variety of surgical procedures or to manage acute or chronic pain. This block can potentially provide analgesia to the posterior pelvis potentially safer alternative to epidural or paravertebral techniques, areas often involved in hip fracture pain.
The pericapsular nerve group block targets the articular branches of the femoral and obturator nerves near the hip joint capsule. By blocking these nerves, the pericapsular nerve group block effectively provides analgesia to the hip joint, particular tissues, and proximal femur.
- Conditions
- Pericapsular Nerve, Lumbar Erector Spinae Plane Blocks, Geriatrics, Total Hip Arthroplasty, General Anesthesia
- Being tested
- General anesthesia, Bupivacaine 0.5%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesiaDrug
Patients will receive general anesthesia.
Bupivacaine 0.5%Drug
Also called Erector spinae plane block
Patients will receive general anesthesia and erector spinae plane block.
Bupivacaine 0.5%Drug
Also called Pericapsular nerve block
Patients will receive general anesthesia and erector spinae plane block with pericapsular nerve block.
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia group | Experimental | Patients will receive general anesthesia. Receives: Drug: General anesthesia |
| Erector spinae plane block group | Experimental | Patients will receive general anesthesia and erector spinae plane block. Receives: Drug: Bupivacaine 0.5% |
| Pericapsular nerve block group | Experimental | Patients will receive general anesthesia and erector spinae plane block with pericapsular nerve block. Receives: Drug: Bupivacaine 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean sevoflurane MAC to achieve bispectral index (BIS) values (45-55)
Sevoflurane will be adjusted to maintain a steady state with a BIS value in the range of 45-55 and will be fixed through the study period
Measured: Intraoperatively
Secondary outcomes (7)
Pain degree
Each patient will be instructed about postoperative pain assessment with the Numerical Rating Scale (NRS). NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").Pain intensity will be measured using a 10-point NRS at rest at 2, 4, 8, 12, 18, and 24 hours postoperatively.
Measured: 24 hours postoperatively
Fentanyl consumption.
Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain).
Measured: Intraoperatively
Arterial blood pressure
MAP will be recorded pre-induction of anesthesia, post-induction of anesthesia and before performing of block, and every 15 min till the end of surgery. Intraoperative arterial blood pressure will be assessed. Hypotension (decrease in basal mean arterial blood pressure by 20%) will be treated with IV fluid.
Measured: Till the end of surgery (up to 2 hours)
Heart rate
HR will be recorded pre-induction of anesthesia, post-induction of anesthesia and before performing of block, and every 15 min till the end of surgery.
Measured: Till the end of surgery (up to 2 hours)
Total postoperative morphine consumption.
Total postoperative morphine consumption in the first 24h after surgery will be recorded. Rescue analgesia of morphine will be given as 0.05mg/kg bolus if the Numerical Rating Scale (NRS) > 3 to be repeated after 30 min if pain persists until the NRS < 4.
Measured: First 24 hours after surgery
Patient satisfaction
Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied). It will be assessed 24 hours after surgery.
Measured: 24 hours after surgery
Complications
Complications such as bradycardia, hypotension, nausea, vomiting, pruritis, respiratory depression will be recorded.
Measured: 24 hours Postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start1 Dec 2024
- Primary completion1 Nov 2026
- Study completion1 Nov 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pericapsular NerveStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai El-saieed Abdelghaffar Hamada, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904703
- Sponsor's protocol ID
- 36265MD311/11/24
- Status last verified
- Nov 2026
- First submitted
- 22 Mar 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Pericapsular Nerve Group and Lumbar Erector Spinae Plane Blocks for Geriatrics Undergoing Total Hip Arthroplasty Under General Anesthesia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06904703
- Acronym / sponsor ID
- 36265MD311/11/24
- Conditions
- Pericapsular Nerve, Lumbar Erector Spinae Plane Blocks, Geriatrics, Total Hip Arthroplasty, General Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Nov 2026 (actual)
- Study completion
- 1 Nov 2026 (actual)
- First posted
- 1 Apr 2025 (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.
This study will be conducted to evaluate the effect of pericapsular nerve group and erector spinae plane block as adjuvants to general anesthesia in geriatrics undergoing total hip arthroplasty.
Detailed description
Total hip arthroplasty is one of the most common major orthopedic procedures to improve a patient's functional status and quality of life. Total hip arthroplasty is one of the most cost-effective and consistently successful surgeries performed in orthopedics and can be associated with significant postoperative pain.
General anesthesia may be considered more versatile and suitable for patients with complex medical histories or those who cannot tolerate spinal anesthesia. However, older patients undergoing hip fracture surgery under general anesthesia may experience a higher risk of postoperative delirium, prolonged sedation, and respiratory complications. Moreover, delayed mobilization is possible, leading to a higher incidence of complications such as deep vein thrombosis and pressure sores.
The target nerves of the hip joint arise from the lumbar plexus (L1-L4), the lumbosacral trunk of the sacral plexus (L4-L5), and the sacral spinal nerves (S1-S4) (7). The femoral nerve, obturator nerve, and the accessory obturator nerve supply the anterior capsule of the hip; the sciatic nerve and the nerve to the quadratus femoris mostly supply the articular branches to the posterior capsule of the hip joint The erector spinae plane block is a novel inter-fascial plane block targets the dorsal and ventral rami of the spinal nerves, is a newer regional anesthetic technique that can be used to provide analgesia for a variety of surgical procedures or to manage acute or chronic pain. This block can potentially provide analgesia to the posterior pelvis potentially safer alternative to epidural or paravertebral techniques, areas often involved in hip fracture pain.
The pericapsular nerve group block targets the articular branches of the femoral and obturator nerves near the hip joint capsule. By blocking these nerves, the pericapsular nerve group block effectively provides analgesia to the hip joint, particular tissues, and proximal femur.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| General anesthesia group | Experimental | Drug: General anesthesiaPatients will receive general anesthesia. |
| Erector spinae plane block group | Experimental | Drug: Bupivacaine 0.5%Patients will receive general anesthesia and erector spinae plane block. |
| Pericapsular nerve block group | Experimental | Drug: Bupivacaine 0.5%Patients will receive general anesthesia and erector spinae plane block with pericapsular nerve block. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Aged >75 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) classification I-III.
- Undergoing total hip arthroplasty under general anesthesia.
Key exclusion criteria (6 listed)
- Patient refusal.
- Body mass index (BMI) > 30 kg/m2.
- Allergy to local anesthesia drugs.
- Infection at the site of intervention.
- Coagulopathies.
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 |
|---|---|---|
| General anesthesiaPatients will receive general anesthesia. | Drug | General anesthesia group |
| Bupivacaine 0.5%Also: Erector spinae plane blockPatients will receive general anesthesia and erector spinae plane block. | Drug | Erector spinae plane block group |
| Bupivacaine 0.5%Also: Pericapsular nerve blockPatients will receive general anesthesia and erector spinae plane block with pericapsular nerve block. | Drug | Pericapsular nerve block group |
Primary outcome
Mean sevoflurane MAC to achieve bispectral index (BIS) values (45-55)
Time frame: Intraoperatively
Sevoflurane will be adjusted to maintain a steady state with a BIS value in the range of 45-55 and will be fixed through the study period
7 secondary outcomes
Pain degree
Time frame: 24 hours postoperatively
Fentanyl consumption.
Time frame: Intraoperatively
Arterial blood pressure
Time frame: Till the end of surgery (up to 2 hours)
Heart rate
Time frame: Till the end of surgery (up to 2 hours)
Total postoperative morphine consumption.
Time frame: First 24 hours after surgery
Patient satisfaction
Time frame: 24 hours after surgery
Complications
Time frame: 24 hours Postoperatively
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 5 Nov 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 General anesthesia and Bupivacaine 0.5% in people with Pericapsular Nerve and Lumbar Erector Spinae Plane Blocks, 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 4 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 5 Nov 2026. 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?
Mean sevoflurane MAC to achieve bispectral index (BIS) values (45-55) (time frame: Intraoperatively). 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 5 Nov 2026.