Hip HemiarthroplastyNCT06369948
Quality Of Recovery After Pericapsular Nerve Group (PENG) Block For Hip Hemiarthroplasty Under Spinal Anesthesia
A study testing Pericapsular Nerve Group (PENG) Block, elective hip hemiarthroplasty without receiving a PENG block. and bupivacaine 0.5% injection in people with Hip Hemiarthroplasty, run by Fayoum University Hospital at 1 site in Egypt.
Trial summary
Patients undergoing hip hemiarthroplasty can benefit significantly from regional anesthesia in terms of pain management and recovery . There is a wide range of regional anesthetic techniques. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hip Hemiarthroplasty
- What is being tested?
- Pericapsular Nerve Group (PENG) Block, elective hip hemiarthroplasty without receiving a PENG block. and bupivacaine 0.5% injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 Sep 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - patients 18 years old or older with ASA physical status 1-3, patients who had no contraindications for spinal anesthesia, and patients undergoing elective surgery.
Who cannot join
- Patients with ASA physical status 4 or above.
- Pre-existing anatomical or neurological deficits in the lower extremity.
- Intolerance or allergy to local anesthetics.
- Narcotic dependency.
- Coagulopathy or using antiplatelet or anticoagulant medications.
- Neuromuscular diseases.
- Psychiatric illnesses (schizophrenia, bipolar, uncontrolled anxiety or depression).
- Systemic infections or infections at site of injection.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Fayoum University Hospital
El Fayoum Qesm, Fayoum Governorate, 63514
About this study
Official title: Quality Of Recovery After Pericapsular Nerve Group (PENG) Block For Hip Hemiarthroplasty Under Spinal Anesthesia: A Prospective, Double-Blinded, Randomized Controlled Trial
Patients undergoing hip hemiarthroplasty can benefit significantly from regional anesthesia in terms of pain management and recovery . There is a wide range of regional anesthetic techniques. The most common in this anatomical region and those with the greatest published research are fascia iliac block, lumbar plexus block, and femoral nerve block . Alternative methods include lateral femoral cutaneous nerve and selective obturator nerve infiltration blocks. Novel techniques, including local infiltration analgesia and quadratus lumborum block, have been reported.
While femoral nerve and lumbar plexus blocks are two common opioid-sparing regional anesthetic procedures that are successful, they come with a risk of undesired lower limb muscle weakness . On the other hand, the fascia iliac block does not always offer sufficient pain relief following hip surgery. The important landmarks targeted on the hip joint branches from the femoral nerve and the auxiliary obturator nerve may now be identified thanks to a recent anatomical study on hip innervation .
This led to the discovery of a novel localized anesthetic treatment termed pericapsular nerve group block (PENG), which blocks these nerves to target the hip's anterior capsule. The PENG block has been suggested as a successful motor-sparing block for hip hemiarthroplasty . The objective of the current study is to evaluate the efficacy of the pericapsular nerve group block (PENG) for the reduction of opioid consumption and management of postoperative pain after hip hemiarthroplasty.
Read the detailed description
This study will be performed in the Fayoumi University Hospital after approval by the local Institutional Ethics Committee and local institutional review board. The study design will be a double-blinded, randomized controlled study trial. The researcher will inform the participants about the objectives of the study, the examination, and the investigation that will be done. Also, the confidentiality of their information and their right not to participate in the study. Written informed consent will be obtained from all patients included in the study.
The study will include 60 patients who will undergo elective hip hemiarthroplasty. Patients will be divided into two groups randomized by computer generated random numbers that will be placed in separate opaque envelopes that will be opened by study investigators just before the block.
Pericapsular Nerve Group (PENG) Block (P group) includes 30 patients who will receive a PENG block.
Control group (C group) includes 30 patients who will not receive a PENG block. A full medical history will be taken from the included patients, including demographic data (age, body mass index , weight, gender), general medical history (Diabetes, Hypertension, medication use), anesthesia, and previous surgeries. The patients' fasting durations will be 8 hours for solids and 2 hours for clear liquids. All patients will be assessed Preoperative for VAS score. All patients were monitored by 5 lead ECG, pulse oximetry, non-invasive blood pressure and an intravenous access will be established.
The technique of spinal anesthesia will be standardized for all patients, an attending anesthesiologist will use a 25-gauge Quincke spinal needle (Spinocan, B. Braun Melsungen AG, Germany) to induce spinal anesthesia in the L3/4 or L4/5 vertebral interspace. Throughout the course of the trial, the attending anesthesiologist will chose the dosages of 0.5% hyperbaric bupivacaine (10 to 15 mg) and fentanyl (15 mcg), aiming for a sensory block at the T4 level. The patient will be placed in the sitting or left lateral position while the spinal injection is given over a period of 15 to 30 seconds. Three minutes following the spinal injection, the sensory block was evaluated with a cold and pinprick test. The patient will be placed in a supine position, neutral-head resting posture in the operating area as standard monitors that mentioned before .
Data will be gathered, coded to make data manipulation easier, double-entered into Microsoft Access, and will be analyzed using SPSS software version 22 running on Windows 7 (SPSS Inc., Chicago, IL, USA). Simple descriptive analysis will use percentages and numbers for qualitative data, arithmetic means for measuring central tendency, and standard deviations for quantifying dispersion for parametric quantitative data.
- For quantitative data: Independent samples t-test will be used to compare quantitative measures between two independent groups Paired t-test will be used to compare two dependent quantitative data.
- For qualitative data The Chi-square test will be used to compare two of more than two qualitative groups.
- Sensitivity and specificity test for testing a new test with ROC curve "Receiver Operating Characteristic".
- The P-value< 0.05 will be considered statistically significant.
- Conditions
- Hip Hemiarthroplasty
- Being tested
- Pericapsular Nerve Group (PENG) Block, elective hip hemiarthroplasty without receiving a PENG block., bupivacaine 0.5% injection
- Keywords
- PENG block, pain management, spinal Anesthesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericapsular Nerve Group (PENG) BlockProcedure or surgery
The PENG block will be performed with the patient in the supine position. A linear high-frequency ultrasound probe (GE LOGIQ/P7 ultrasound, korea/ L6-12RS probe) is initially placed in a transverse plane over the anterior inferior iliac spine (AIIS); the probe is turned slightly medial until the hyperechoic continuous shadow of the iliopubic eminence (IPE). The target will be the plane between the psoas tendon and pubic ramus. The skin puncture site will be anesthetized using lidocaine 2% after skin disinfection and draping. A 22-gauge, 100 mm echogenic needle (Spinocan, B. Braun Melsungen AG, Germany) will be inserted in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, 25 mL of the local anesthetic solution (bupivacaine 0.5%) was injected in 5 mL increments while observing for adequate fluid spread in this plane.
elective hip hemiarthroplasty without receiving a PENG block.Procedure or surgery
elective hip hemiarthroplasty without receiving a PENG block.
bupivacaine 0.5% injectionDrug
bupivacaine 0.5% injection
| Study group | Role | What they receive |
|---|---|---|
| Pericapsular Nerve Group (PENG) Block (P group) | Experimental | Patients who will undergo elective hip hemiarthroplasty and receive the Pericapsular Nerve Group (PENG) block postoperatively. Receives: Procedure: Pericapsular Nerve Group (PENG) Block; Drug: bupivacaine 0.5% injection |
| Control group (C group) | Active comparator | Patients who will undergo elective hip hemiarthroplasty without receiving a PENG block. Receives: Procedure: elective hip hemiarthroplasty without receiving a PENG block. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption post operative
total dose of any opioid drug used for pain control postoperative
Measured: from zero hour and at time intervals: 30 minutes, 1hour, 3 hour, 6 our., 12 hour, 24 hour, 48 hour, and 36 hour after block administration
Secondary outcomes (6)
2) a Visual Analogue Scale (VAS) ranging from zero (no pain) to 10 (severe pain) for dynamic and static pain
Degree of pain as measured by fascial expression with rang from 0 for no pain to 10 for sever pain
Measured: at time intervals: 30 minutes, 1hour, 3 hour, 6 hour, 12 hour, 24 hour, 48 hour, and 72 hour. after block administration
3) Time to first opioid use
time taken till first dose of opioid drugs to control pain after 24 hour of block administration
Measured: first 24 hour after block administration
4) Ability to perform physiotherapy
time taken until the participant able to perform physiotherapy in first 24 hour after block administration
Measured: 1 year
5) Opioid-related side effects.
side effects of opioids used for pain control after surgery
Measured: 1 year
6) Total length stay of hospital
time of stay of the participant in the hospital after surgery and block administration
Measured: 1 year
7) Complications of local anesthetic toxicity
complication of local anesthetic drug injected in the procedure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Mar 2024
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Hip HemiarthroplastyStudies 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
- We will include 60 patients who will undergoe elective hip hemiarthroplasty. Patients will be divided into two groups randomized by computer generated random numbers that will be placed in separate opaque envelopes that will be opened by study investigators just before the block. Pericapsular Nerve Group (PENG) Block (P group) includes 30 patients who will receive a PENG block. Control group (C group) includes 30 patients who will not receive a PENG block.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atef Mohamed mahmoud, Fayoum University Hospital
- Investigators
- Atef Mohamed Sayed, MS.C, Principal investigator, Faculty of medicine, Fayoum university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369948
- Sponsor's protocol ID
- M703
- Status last verified
- Dec 2025
- First submitted
- 31 Mar 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Meng Y, Deng B, Liang X, Li J, Li L, Ou J, Yu S, Tan X, Chen Y, Zhang M. Effectiveness of self-efficacy-enhancing interventions on rehabilitation following total hip replacement: a randomized controlled trial with six-month follow-up. J Orthop Surg Res. 2022 Apr 10;17(1):225. doi: 10.1186/s13018-022-03116-2.
PubMed 35399102van Drongelen S, Kaldowski H, Tarhan T, Assi A, Meurer A, Stief F. Are changes in radiological leg alignment and femoral parameters after total hip replacement responsible for joint loading during gait? BMC Musculoskelet Disord. 2019 Nov 10;20(1):526. doi: 10.1186/s12891-019-2832-5.
PubMed 31707985Zaballa E, Dennison E, Walker-Bone K. Function and employment after total hip replacement in older adults: A narrative review. Maturitas. 2023 Jan;167:8-16. doi: 10.1016/j.maturitas.2022.09.005. Epub 2022 Sep 14.
PubMed 36302339Chen L, Chen G. The Effect of Resistance Training on the Function after Hip Replacement: A Meta-analysis of Randomized Controlled Trials. Z Orthop Unfall. 2021 Aug;159(4):383-390. doi: 10.1055/a-1154-8949. Epub 2020 Dec 9.
PubMed 33296947Domingue G, Warren D, Koval KJ, Riehl JT. Complications of Hip Hemiarthroplasty. Orthopedics. 2023 Jul-Aug;46(4):e199-e209. doi: 10.3928/01477447-20230125-06. Epub 2023 Jan 30.
PubMed 36719411Tsai MC, Ng YY, Chen WM, Tsai SW, Wu SC. The effects of cement fixation on survival in elderly patients with hip hemiarthroplasty: a nationwide cohort study. BMC Musculoskelet Disord. 2019 Dec 27;20(1):628. doi: 10.1186/s12891-019-3013-2.
PubMed 31881878Lee C, Freeman R, Edmondson M, Rogers BA. The efficacy of tranexamic acid in hip hemiarthroplasty surgery: an observational cohort study. Injury. 2015 Oct;46(10):1978-82. doi: 10.1016/j.injury.2015.06.039. Epub 2015 Jul 6.
PubMed 26190627Pala E, Trono M, Bitonti A, Lucidi G. Hip hemiarthroplasty for femur neck fractures: minimally invasive direct anterior approach versus postero-lateral approach. Eur J Orthop Surg Traumatol. 2016 May;26(4):423-7. doi: 10.1007/s00590-016-1767-x. Epub 2016 Mar 30.
PubMed 27026091Spaans EA, Koenraadt KLM, Wagenmakers R, Elmans LHGJ, van den Hout JAAM, Eygendaal D, Bolder SBT. Does surgeon volume influence the outcome after hip hemiarthroplasty for displaced femoral neck fractures; early outcome, complications, and survival of 752 cases. Arch Orthop Trauma Surg. 2019 Feb;139(2):255-261. doi: 10.1007/s00402-018-3076-9. Epub 2018 Nov 27.
PubMed 30483916Moore BF, Lachiewicz PF. Corrosion and adverse tissue reaction after modular unipolar hip hemiarthroplasty. Arthroplast Today. 2017 Feb 21;3(4):207-210. doi: 10.1016/j.artd.2017.01.002. eCollection 2017 Dec.
PubMed 29204481Verzellotti S, Candrian C, Molina M, Filardo G, Alberio R, Grassi FA. Direct anterior versus posterolateral approach for bipolar hip hemiarthroplasty in femoral neck fractures: a prospective randomised study. Hip Int. 2020 Nov;30(6):810-817. doi: 10.1177/1120700019872117. Epub 2019 Aug 26.
PubMed 31450987Short AJ, Barnett JJG, Gofeld M, Baig E, Lam K, Agur AMR, Peng PWH. Anatomic Study of Innervation of the Anterior Hip Capsule: Implication for Image-Guided Intervention. Reg Anesth Pain Med. 2018 Feb;43(2):186-192. doi: 10.1097/AAP.0000000000000701.
PubMed 29140962Morrison C, Brown B, Lin DY, Jaarsma R, Kroon H. Analgesia and anesthesia using the pericapsular nerve group block in hip surgery and hip fracture: a scoping review. Reg Anesth Pain Med. 2021 Feb;46(2):169-175. doi: 10.1136/rapm-2020-101826. Epub 2020 Oct 27.
PubMed 33109730Kupeli I, Yazici Kara M. Anesthesia or analgesia? New block for shoulder surgery: pericapsular nerve group block. Braz J Anesthesiol. 2022 Sep-Oct;72(5):669-672. doi: 10.1016/j.bjane.2021.05.009. Epub 2021 Jun 9.
PubMed 34118263Gullupinar B, Saglam C, Unluer EE, Ayvat P, Ozturk K, Gul M, Tandon S. Effectiveness of pericapsular nerve group block with ultrasonography in patients diagnosed with hip fracture in the emergency department. Ulus Travma Acil Cerrahi Derg. 2022 Jun;28(6):832-838. doi: 10.14744/tjtes.2022.67817.
PubMed 35652877
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Of Recovery After Pericapsular Nerve Group (PENG) Block For Hip Hemiarthroplasty Under Spinal Anesthesia: A Prospective, Double-Blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06369948
- Acronym / sponsor ID
- M703
- Conditions
- Hip Hemiarthroplasty
- Keywords
- PENG block, pain management, spinal Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 17 Apr 2024 (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.
Patients undergoing hip hemiarthroplasty can benefit significantly from regional anesthesia in terms of pain management and recovery . There is a wide range of regional anesthetic techniques. The most common in this anatomical region and those with the greatest published research are fascia iliac block, lumbar plexus block, and femoral nerve block . Alternative methods include lateral femoral cutaneous nerve and selective obturator nerve infiltration blocks. Novel techniques, including local infiltration analgesia and quadratus lumborum block, have been reported.
While femoral nerve and lumbar plexus blocks are two common opioid-sparing regional anesthetic procedures that are successful, they come with a risk of undesired lower limb muscle weakness . On the other hand, the fascia iliac block does not always offer sufficient pain relief following hip surgery. The important landmarks targeted on the hip joint branches from the femoral nerve and the auxiliary obturator nerve may now be identified thanks to a recent anatomical study on hip innervation .
This led to the discovery of a novel localized anesthetic treatment termed pericapsular nerve group block (PENG), which blocks these nerves to target the hip's anterior capsule. The PENG block has been suggested as a successful motor-sparing block for hip hemiarthroplasty . The objective of the current study is to evaluate the efficacy of the pericapsular nerve group block (PENG) for the reduction of opioid consumption and management of postoperative pain after hip hemiarthroplasty.
Detailed description
This study will be performed in the Fayoumi University Hospital after approval by the local Institutional Ethics Committee and local institutional review board. The study design will be a double-blinded, randomized controlled study trial. The researcher will inform the participants about the objectives of the study, the examination, and the investigation that will be done. Also, the confidentiality of their information and their right not to participate in the study. Written informed consent will be obtained from all patients included in the study.
The study will include 60 patients who will undergo elective hip hemiarthroplasty. Patients will be divided into two groups randomized by computer generated random numbers that will be placed in separate opaque envelopes that will be opened by study investigators just before the block.
Pericapsular Nerve Group (PENG) Block (P group) includes 30 patients who will receive a PENG block.
Control group (C group) includes 30 patients who will not receive a PENG block. A full medical history will be taken from the included patients, including demographic data (age, body mass index , weight, gender), general medical history (Diabetes, Hypertension, medication use), anesthesia, and previous surgeries. The patients' fasting durations will be 8 hours for solids and 2 hours for clear liquids. All patients will be assessed Preoperative for VAS score. All patients were monitored by 5 lead ECG, pulse oximetry, non-invasive blood pressure and an intravenous access will be established.
The technique of spinal anesthesia will be standardized for all patients, an attending anesthesiologist will use a 25-gauge Quincke spinal needle (Spinocan, B. Braun Melsungen AG, Germany) to induce spinal anesthesia in the L3/4 or L4/5 vertebral interspace. Throughout the course of the trial, the attending anesthesiologist will chose the dosages of 0.5% hyperbaric bupivacaine (10 to 15 mg) and fentanyl (15 mcg), aiming for a sensory block at the T4 level. The patient will be placed in the sitting or left lateral position while the spinal injection is given over a period of 15 to 30 seconds. Three minutes following the spinal injection, the sensory block was evaluated with a cold and pinprick test. The patient will be placed in a supine position, neutral-head resting posture in the operating area as standard monitors that mentioned before .
Data will be gathered, coded to make data manipulation easier, double-entered into Microsoft Access, and will be analyzed using SPSS software version 22 running on Windows 7 (SPSS Inc., Chicago, IL, USA). Simple descriptive analysis will use percentages and numbers for qualitative data, arithmetic means for measuring central tendency, and standard deviations for quantifying dispersion for parametric quantitative data.
- For quantitative data: Independent samples t-test will be used to compare quantitative measures between two independent groups Paired t-test will be used to compare two dependent quantitative data.
- For qualitative data The Chi-square test will be used to compare two of more than two qualitative groups.
- Sensitivity and specificity test for testing a new test with ROC curve "Receiver Operating Characteristic".
- The P-value< 0.05 will be considered statistically significant.
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
- We will include 60 patients who will undergoe elective hip hemiarthroplasty. Patients will be divided into two groups randomized by computer generated random numbers that will be placed in separate opaque envelopes that will be opened by study investigators just before the block. Pericapsular Nerve Group (PENG) Block (P group) includes 30 patients who will receive a PENG block. Control group (C group) includes 30 patients who will not receive a PENG block.
| Arm | Type | Receives |
|---|---|---|
| Pericapsular Nerve Group (PENG) Block (P group) | Experimental | Procedure: Pericapsular Nerve Group (PENG) Block, Drug: bupivacaine 0.5% injectionPatients who will undergo elective hip hemiarthroplasty and receive the Pericapsular Nerve Group (PENG) block postoperatively. |
| Control group (C group) | Active comparator | Procedure: elective hip hemiarthroplasty without receiving a PENG block.Patients who will undergo elective hip hemiarthroplasty without receiving a PENG block. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- - patients 18 years old or older with ASA physical status 1-3, patients who had no contraindications for spinal anesthesia, and patients undergoing elective surgery.
Key exclusion criteria (8 listed)
- Patients with ASA physical status 4 or above.
- Pre-existing anatomical or neurological deficits in the lower extremity.
- Intolerance or allergy to local anesthetics.
- Narcotic dependency.
- Coagulopathy or using antiplatelet or anticoagulant medications.
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 (PENG) BlockThe PENG block will be performed with the patient in the supine position. A linear high-frequency ultrasound probe (GE LOGIQ/P7 ultrasound, korea/ L6-12RS probe) is initially placed in a transverse plane over the anterior inferior iliac spine (AIIS); the probe is turned slightly medial until the hyperechoic continuous shadow of the iliopubic eminence (IPE). The target will be the plane between the psoas tendon and pubic ramus. The skin puncture site will be anesthetized using lidocaine 2% after skin disinfection and draping. A 22-gauge, 100 mm echogenic needle (Spinocan, B. Braun Melsungen AG, Germany) will be inserted in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, 25 mL of the local anesthetic solution (bupivacaine 0.5%) was injected in 5 mL increments while observing for adequate fluid spread in this plane. | Procedure or surgery | Pericapsular Nerve Group (PENG) Block (P group) |
| elective hip hemiarthroplasty without receiving a PENG block.elective hip hemiarthroplasty without receiving a PENG block. | Procedure or surgery | Control group (C group) |
| bupivacaine 0.5% injectionbupivacaine 0.5% injection | Drug | Pericapsular Nerve Group (PENG) Block (P group) |
Primary outcome
Total opioid consumption post operative
Time frame: from zero hour and at time intervals: 30 minutes, 1hour, 3 hour, 6 our., 12 hour, 24 hour, 48 hour, and 36 hour after block administration
total dose of any opioid drug used for pain control postoperative
6 secondary outcomes
2) a Visual Analogue Scale (VAS) ranging from zero (no pain) to 10 (severe pain) for dynamic and static pain
Time frame: at time intervals: 30 minutes, 1hour, 3 hour, 6 hour, 12 hour, 24 hour, 48 hour, and 72 hour. after block administration
3) Time to first opioid use
Time frame: first 24 hour after block administration
4) Ability to perform physiotherapy
Time frame: 1 year
5) Opioid-related side effects.
Time frame: 1 year
6) Total length stay of hospital
Time frame: 1 year
7) Complications of local anesthetic toxicity
Time frame: 1 year
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 Dec 2025.
- Background: PubMed 35399102Meng Y, Deng B, Liang X, Li J, Li L, Ou J, Yu S, Tan X, Chen Y, Zhang M. Effectiveness of self-efficacy-enhancing interventions on rehabilitation following total hip replacement: a randomized controlled trial with six-month follow-up. J Orthop Surg Res. 2022 Apr 10;17(1):225. doi: 10.1186/s13018-022-03116-2.
- Background: PubMed 31707985van Drongelen S, Kaldowski H, Tarhan T, Assi A, Meurer A, Stief F. Are changes in radiological leg alignment and femoral parameters after total hip replacement responsible for joint loading during gait? BMC Musculoskelet Disord. 2019 Nov 10;20(1):526. doi: 10.1186/s12891-019-2832-5.
- Background: PubMed 36302339Zaballa E, Dennison E, Walker-Bone K. Function and employment after total hip replacement in older adults: A narrative review. Maturitas. 2023 Jan;167:8-16. doi: 10.1016/j.maturitas.2022.09.005. Epub 2022 Sep 14.
- Background: PubMed 33296947Chen L, Chen G. The Effect of Resistance Training on the Function after Hip Replacement: A Meta-analysis of Randomized Controlled Trials. Z Orthop Unfall. 2021 Aug;159(4):383-390. doi: 10.1055/a-1154-8949. Epub 2020 Dec 9.
- Background: PubMed 36719411Domingue G, Warren D, Koval KJ, Riehl JT. Complications of Hip Hemiarthroplasty. Orthopedics. 2023 Jul-Aug;46(4):e199-e209. doi: 10.3928/01477447-20230125-06. Epub 2023 Jan 30.
- Background: PubMed 31881878Tsai MC, Ng YY, Chen WM, Tsai SW, Wu SC. The effects of cement fixation on survival in elderly patients with hip hemiarthroplasty: a nationwide cohort study. BMC Musculoskelet Disord. 2019 Dec 27;20(1):628. doi: 10.1186/s12891-019-3013-2.
- Background: PubMed 26190627Lee C, Freeman R, Edmondson M, Rogers BA. The efficacy of tranexamic acid in hip hemiarthroplasty surgery: an observational cohort study. Injury. 2015 Oct;46(10):1978-82. doi: 10.1016/j.injury.2015.06.039. Epub 2015 Jul 6.
- Background: PubMed 27026091Pala E, Trono M, Bitonti A, Lucidi G. Hip hemiarthroplasty for femur neck fractures: minimally invasive direct anterior approach versus postero-lateral approach. Eur J Orthop Surg Traumatol. 2016 May;26(4):423-7. doi: 10.1007/s00590-016-1767-x. Epub 2016 Mar 30.
- Background: PubMed 30483916Spaans EA, Koenraadt KLM, Wagenmakers R, Elmans LHGJ, van den Hout JAAM, Eygendaal D, Bolder SBT. Does surgeon volume influence the outcome after hip hemiarthroplasty for displaced femoral neck fractures; early outcome, complications, and survival of 752 cases. Arch Orthop Trauma Surg. 2019 Feb;139(2):255-261. doi: 10.1007/s00402-018-3076-9. Epub 2018 Nov 27.
- Background: PubMed 29204481Moore BF, Lachiewicz PF. Corrosion and adverse tissue reaction after modular unipolar hip hemiarthroplasty. Arthroplast Today. 2017 Feb 21;3(4):207-210. doi: 10.1016/j.artd.2017.01.002. eCollection 2017 Dec.
- Background: PubMed 31450987Verzellotti S, Candrian C, Molina M, Filardo G, Alberio R, Grassi FA. Direct anterior versus posterolateral approach for bipolar hip hemiarthroplasty in femoral neck fractures: a prospective randomised study. Hip Int. 2020 Nov;30(6):810-817. doi: 10.1177/1120700019872117. Epub 2019 Aug 26.
- Background: PubMed 29140962Short AJ, Barnett JJG, Gofeld M, Baig E, Lam K, Agur AMR, Peng PWH. Anatomic Study of Innervation of the Anterior Hip Capsule: Implication for Image-Guided Intervention. Reg Anesth Pain Med. 2018 Feb;43(2):186-192. doi: 10.1097/AAP.0000000000000701.
- Individual participant dataSharing planned: Undecided
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Femoral Neck Fracture
Active, not recruiting
Anterior vs Posterior Approach for Hip Hemiarthroplasty
Hip Fractures
Recruiting
Efficacy and Safety of Topical Tranexamic Acid (TXA) Administration Cementless Bipolar Hemiarthroplasty for Femoral Neck Fracture - a Randomized Controlled Trial
Femoral Neck Fracture
RecruitingObservational study
CoCrMo LOCK Bipolar Femoral Heads FU
Femoral Fractures, Hip Arthropathy
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.
Atef Mohamed Sayed, MS.C principal investigator
Faculty of medicine, Fayoum 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 Pericapsular Nerve Group (PENG) Block, elective hip hemiarthroplasty without receiving a PENG block. and bupivacaine 0.5% injection in people with Hip Hemiarthroplasty, run by Fayoum University Hospital 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 1 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 18 Dec 2025. 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?
Total opioid consumption post operative (time frame: from zero hour and at time intervals: 30 minutes, 1hour, 3 hour, 6 our., 12 hour, 24 hour, 48 hour, and 36 hour after block administration). 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 NCT06369948, which also lists 20 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 18 Dec 2025.