Total Hip SurgeryNCT05600244
PENG vs. QLB vs. Lumbar ESPB in Total Hip Surgery
A study testing PENG block Technique, Lumbar ESPB Technique and Transmuscular QLB-t block Technique in people with Total Hip Surgery and Pericapsular Nerve, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The aim of this study is to compare between Pericapsular Nerve Group Block, Erector Spinae Plane Block and Quadratus Lumborum Block for managing acute postoperative pain in patients undergoing total hip surgeries under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Total Hip Surgery, Pericapsular Nerve, Quadratus Lumborum
- What is being tested?
- PENG block Technique, Lumbar ESPB Technique and Transmuscular QLB-t block Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2022to 10 Oct 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Both genders
- Body mass index < 40 kg/m^2
- American Society of Anesthesiologists (ASA) physical status I-III
- Posted for total hip surgeries under spinal anesthesia
Who cannot join
- The presence of contraindications or allergy to local anesthetic agents
- Chronic use of opioids or corticosteroids
- Infection at the puncture site
- Coagulopathy
- Psychiatric disorders (dementia or cognitive impairment.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mohammad Fouad Algyar
Tanta, ElGharbiaa, 31511
Mohammad F Algyar, MD, 00201111645345, mohammad.algaiar@med.kfs.edu.eg
About this study
Official title: Comparison of Pericapsular Nerve Group Block, Quadratus Lumborum Block and Lumbar Erector Spinae Plane Block for Acute Pain Management in Total Hip Surgery: A Randomized Clinical Trial
The aim of this study is to compare between Pericapsular Nerve Group Block, Erector Spinae Plane Block and Quadratus Lumborum Block for managing acute postoperative pain in patients undergoing total hip surgeries under spinal anesthesia.
Read the detailed description
Total hip surgeries are one of the most common major orthopedic procedures to improve patient's functional status and quality of life. However, despite these advantages, the immediate postoperative period can be associated with severe pain that delays mobilization and increases hospital stay and the risk of thromboembolic events.
Various methods are used for postoperative pain management. Intravenous opioid agents are among them, but they may cause undesirable side effects, such as respiratory depression, sedation, constipation, allergic reaction, nausea, and vomiting. Thus, alternative techniques are preferred.
- Conditions
- Total Hip Surgery, Pericapsular Nerve, Quadratus Lumborum, ESPB
- Being tested
- PENG block Technique, Lumbar ESPB Technique, Transmuscular QLB-t block Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG block TechniqueProcedure or surgery
A linear probe will be used. Puncture will be performed in a lateromedial direction until the needle tip reached the plane between the iliopsoas tendon and periosteum and between the anterior inferior iliac spine and iliopubic eminence. After a negative aspiration test, 30 ml of bupivacaine 0.25% will be injected in the plane beneath the iliopsoas muscle
Lumbar ESPB TechniqueProcedure or surgery
Using the out-plane technique, a 22G/80-mm block needle will be advanced until it reached the transverse process. 0.5-1 ml of the prepared local anesthetic solution, 30 ml bupivacaine 0.25% will be administered leading to hydrodissection to confirm the correct location. The needle will be repositioned by pulling back a few millimeters if resistance occurs when administering local anesthetic . All local anesthetic will be administered to this location between the transverse process and the erector spinae muscle
Transmuscular QLB-t block TechniqueProcedure or surgery
A convex transducer will be placed in the transverse plane on the flank of the patient cranial to the iliac crest. The 4th lumbar vertebral transverse process, erector spinae muscles, psoas muscle, transverse abdominis muscle, internal and externa oblique muscles, and the quadratus lumborum muscle will be identified. A 15 cm 22G insulated needle will be inserted on the posterior corner of the transducer. 30 ml bupivacaine 0.25% will be administered between the quadratus lumborum and psoas muscles into the fascial plane.
| Study group | Role | What they receive |
|---|---|---|
| PENG block Technique | Experimental | Patients will receive ultrasound-guided Pericapsular Nerve Group Block using 30 ml bupivacaine 0.25%. Receives: Procedure: PENG block Technique |
| Lumbar ESPB Technique | Experimental | Patients will receive lumbar erector spinae plane block using 30 ml bupivacaine 0.25% Receives: Procedure: Lumbar ESPB Technique |
| Transmuscular QLB-t block Technique | Experimental | Patients will receive transmuscular quadratus lumborum block using 30 ml bupivacaine 0.25% Receives: Procedure: Transmuscular QLB-t block Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of rescue analgesia
Total amount of rescue analgesia in the form of morphine will be recorded
Measured: 24 hours postoperatively
Secondary outcomes (3)
First analgesic request
The time to first request of rescue analgesia will be recorded
Measured: 24 hours Postoperatively
Pain level
Pain level will be evaluated using numeric rating analogue scale (NRS), which ranges from 0 to 10 points, with 0 indicating no pain, 1-3 indicating mild pain, 4-6 indicating moderate pain, and 7-10 indicating severe pain.
Measured: 48 hours Postoperatively
Adverse events
Adverse events will be recorded (e.g., nausea, vomiting, hypotension and bradycardia)
Measured: 48 hours Postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start15 Dec 2022
- Primary completion10 Oct 2023 (estimated)
- Study completion10 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip SurgeryStudies 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fouad Algyar, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600244
- Sponsor's protocol ID
- MKSU 50-9-21
- Status last verified
- Sep 2023
- First submitted
- 26 Oct 2022
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available under a reasonable request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pericapsular Nerve Group Block, Quadratus Lumborum Block and Lumbar Erector Spinae Plane Block for Acute Pain Management in Total Hip Surgery: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05600244
- Acronym / sponsor ID
- MKSU 50-9-21
- Conditions
- Total Hip Surgery, Pericapsular Nerve, Quadratus Lumborum, ESPB
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 10 Oct 2023 (estimated)
- Study completion
- 10 Oct 2023 (estimated)
- First posted
- 31 Oct 2022 (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 this study is to compare between Pericapsular Nerve Group Block, Erector Spinae Plane Block and Quadratus Lumborum Block for managing acute postoperative pain in patients undergoing total hip surgeries under spinal anesthesia.
Detailed description
Total hip surgeries are one of the most common major orthopedic procedures to improve patient's functional status and quality of life. However, despite these advantages, the immediate postoperative period can be associated with severe pain that delays mobilization and increases hospital stay and the risk of thromboembolic events.
Various methods are used for postoperative pain management. Intravenous opioid agents are among them, but they may cause undesirable side effects, such as respiratory depression, sedation, constipation, allergic reaction, nausea, and vomiting. Thus, alternative techniques are preferred.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PENG block Technique | Experimental | Procedure: PENG block TechniquePatients will receive ultrasound-guided Pericapsular Nerve Group Block using 30 ml bupivacaine 0.25%. |
| Lumbar ESPB Technique | Experimental | Procedure: Lumbar ESPB TechniquePatients will receive lumbar erector spinae plane block using 30 ml bupivacaine 0.25% |
| Transmuscular QLB-t block Technique | Experimental | Procedure: Transmuscular QLB-t block TechniquePatients will receive transmuscular quadratus lumborum block using 30 ml bupivacaine 0.25% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65 years
- Both genders
- Body mass index < 40 kg/m^2
- American Society of Anesthesiologists (ASA) physical status I-III
- Posted for total hip surgeries under spinal anesthesia
Key exclusion criteria (5 listed)
- The presence of contraindications or allergy to local anesthetic agents
- Chronic use of opioids or corticosteroids
- Infection at the puncture site
- Coagulopathy
- Psychiatric disorders (dementia or cognitive impairment.
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 |
|---|---|---|
| PENG block TechniqueA linear probe will be used. Puncture will be performed in a lateromedial direction until the needle tip reached the plane between the iliopsoas tendon and periosteum and between the anterior inferior iliac spine and iliopubic eminence. After a negative aspiration test, 30 ml of bupivacaine 0.25% will be injected in the plane beneath the iliopsoas muscle | Procedure or surgery | PENG block Technique |
| Lumbar ESPB TechniqueUsing the out-plane technique, a 22G/80-mm block needle will be advanced until it reached the transverse process. 0.5-1 ml of the prepared local anesthetic solution, 30 ml bupivacaine 0.25% will be administered leading to hydrodissection to confirm the correct location. The needle will be repositioned by pulling back a few millimeters if resistance occurs when administering local anesthetic . All local anesthetic will be administered to this location between the transverse process and the erector spinae muscle | Procedure or surgery | Lumbar ESPB Technique |
| Transmuscular QLB-t block TechniqueA convex transducer will be placed in the transverse plane on the flank of the patient cranial to the iliac crest. The 4th lumbar vertebral transverse process, erector spinae muscles, psoas muscle, transverse abdominis muscle, internal and externa oblique muscles, and the quadratus lumborum muscle will be identified. A 15 cm 22G insulated needle will be inserted on the posterior corner of the transducer. 30 ml bupivacaine 0.25% will be administered between the quadratus lumborum and psoas muscles into the fascial plane. | Procedure or surgery | Transmuscular QLB-t block Technique |
Primary outcome
Total amount of rescue analgesia
Time frame: 24 hours postoperatively
Total amount of rescue analgesia in the form of morphine will be recorded
3 secondary outcomes
First analgesic request
Time frame: 24 hours Postoperatively
Pain level
Time frame: 48 hours Postoperatively
Adverse events
Time frame: 48 hours Postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: Yes. The data will be available under a reasonable request from the corresponding author.
Related trials for Total Hip Surgery
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
Not yet recruiting
Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
Orthopedic Surgery, Rehabilitation
Not yet recruitingObservational study
Carotid Ultrasound for Post-Spinal Anesthesia Hypotension in Elderly Hip Surgery
Hypotension After Spinal Anesthesia
Enrolling by invitationPhase 3
A Clinical Trial Evaluating the Efficacy and Safety of Local Infiltration of RF16001 for Injection for Analgesia After Total Hip Arthroplasty in China
Pain After Abdominal Surgery
Active, not recruiting
Comparative Study Between the Effects of Deep Versus Moderate Neuromuscular Blockade on Postoperative Recovery and Immune Function in Patients Undergoing Total Hip Replacement Surgery.
Immune Responses, Post Operative Recovery
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PENG block Technique, Lumbar ESPB Technique and Transmuscular QLB-t block Technique in people with Total Hip Surgery and Pericapsular Nerve, run by Kafrelsheikh 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Sep 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad F. Algyar, MD (111645345 ext. +20, mohammad.algaiar@med.kfs.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amount of rescue analgesia (time frame: 24 hours postoperatively). 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 6 Sep 2023.