Pain, PostoperativeNCT04984109
Ultrasound-guided PENG Block in Total Hip Replacement
A study testing Real PENG block in people with Pain, Postoperative and Opioid Overdose, run by Tanta University at 1 site in Egypt.
Trial summary
This randomized controlled study will be carried out on 60 adult patients undergoing primary total hip replacement in Tanta University Hospitals. All Patients will receive spinal anesthesia with either sham or real US-guided PENG block. The primary outcome will be the time to first request for rescue analgesia. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Pain, Postoperative, Opioid Overdose
- What is being tested?
- Real PENG block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Aug 2021to 30 Jun 2022
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients, aged 21-75 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled to undergo unilateral total hip replacement surgery.
Who cannot join
- Patient refusal.
- Known hypersensitivity to local anesthetics.
- Body mass index > 35 kg /m2.
- Uncooperative or psychiatric patients.
- Infection at the injection site.
- Coagulation disorder.
- Major cardiac, renal, or hepatic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Preoperative Ultrasound-guided Pericapsular Nerve Group Block (PENG) on the Postoperative Analgesia After Total Hip Arthroplasty: Randomized Controlled Study
- This randomized controlled study will be carried out on 60 adult patients undergoing primary total hip replacement in Tanta University Hospitals. All Patients will receive spinal anesthesia with either sham or real US-guided PENG block.
- The primary outcome will be the time to first request for rescue analgesia. The secondary outcome will be the postoperative Numeric Rating Scale (NRS) score and the total morphine consumption (rescue analgesia) in the first 24 h postoperatively.
Read the detailed description
- This prospective randomized double-blinded study will be carried out on 60 adult patients admitted to Tanta University Hospitals for 6 months started immediately after approval of the Institutional Ethical Committee.
- A written informed consent will be obtained from each patient. All data of patients will be confidential with secret codes and private files for each patient, all given data will be used for scientific purposes only after an explanation of the purpose of the study to all patients. - Any unexpected risks encountered during the course of the research will be cleared to the patients as well as to the ethical committee on time.
- The primary endpoint is a prolongation of the postoperative analgesia and reduction of the postoperative analgesic consumption. The study will be terminated if local anesthetic toxicity occurs and this will be announced to the participants and to the ethical committee at the time and adequate measures will be taken to resolve and avoid these risks.
- Group allocation will be done by using computer-generated software of randomization introduced into sealed opaque envelope technique. A blinded nurse, who does not participate in the study or data collection, will read the number contained in the envelope and make group assignments. All the nerve blocks will be performed by one anesthesiologist.
- Control Group: (30 patients) will receive sham PENG (just 1mL saline)
- PENG Group: (30 patients) will receive real PENG (20mL of bupivacaine 0.25% plus 0.2mg/ml dexamethasone)
Anesthetic technique:
•Preoperative assessment will be done by: History taking. Clinical examination. Laboratory investigations including complete blood count, bleeding and clotting times, APTT, liver and kidney function tests.
During the pre-anesthetic assessment, all patients will be familiarized with the Numeric Rating Scale (NRS) score.
- In the holding area, After the establishment of intravascular access by introducing an 18-gauge intravenous (IV) cannula, all the patients will be preloaded with Ringer's lactate solution (7 mL/kg).
- On arrival at operation room, Routine monitoring of heart rate by ECG, noninvasive blood pressure (NIBP), pulse oximetry will be done.
- Lumbar puncture will be performed at the level of L3-L4/L4-L5 intervertebral space with a 25-gauge spinal needle. After ensuring free flow of cerebrospinal fluid, 2 mL of hyperbaric bupivacaine solution (0.5%) (10mg)) with 0.5 mL (25 µg) fentanyl will be injected. The sensory block will be assessed by loss of sensation to pinprick test. The level of the sensory block should achieve at least a level of T10. Moreover, the motor block will be assessed by modified Bromage score till reaching at least a score of 2. (0; means the ability of the patient to move the hip, knee, and ankle, 1; means the inability of the patient to move the hip, but can move the knee and ankle, 2; means the inability of the patient to move the hip and knee, but can move the ankle, and finally 3; means the inability of the patient to move the hip, knee, and ankle). If the sensory and motor block levels will not be achieved within 20 minutes, the patient will be excluded from the study and receive general anesthesia. If the sensory and motor block will be achieved, the patient will receive an ultrasound-guided PENG block before starting the surgery.
- ThePENG block will be performed with the patient in the supine position in the operative area with adequate groin exposure. The probe will first be placed at the anterior superior iliac spine in the transverse plane, and then will be moved caudally to identify the anterior inferior iliac spine (AIIS). The probe will be then rotated to align the AIIS and iliopubic eminence (IPE). This will reveal the iliopsoas tendon and muscle together with femoral vessels superficially. A 22-G 100-mm echogenic needle will be inserted in-plane from lateral to medial, and the tip will be kept at the midpoint of AIIS and IPE deep to psoas tendon. After lifting of the psoas tendon by hydrolocation, the patients in the PENG group will receive 20 ml of (0.25%) bupivacaine with 0.2 mg/ml dexamethasone that will be injected in 5 ml aliquots after negative aspiration.The control group will receive 1 mL of normal saline.
- After completion of the surgical procedure, a patient will be transferred to Post-Anesthesia Care Unit (PACU). Paracetamol 15 mg/kg IV will be administered every 6 hours after discharge to the ward.
- Conditions
- Pain, Postoperative, Opioid Overdose
- Being tested
- Sham PENG block, Real PENG block
- Keywords
- Hip arthroplasty, Pericapsular nerve block, Pain
- Medical subject headings
- Pain, Postoperative, Opiate Overdose, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham PENG blockProcedure or surgery
The regional block will be performed with the patient in the supine position in operative area with adequate groin exposure. The probe will first be placed at the anterior superior iliac spine in transverse plane, and then will be moved caudally to identify anterior inferior iliac spine (AIIS). The probe will be then rotated to align the AIIS and iliopubic eminence (IPE). This will reveal the iliopsoas tendon and muscle together with femoral vessels superficially. A 22-G 100-mm echogenic needle will be inserted in-plane from lateral to medial, and the tip will be kept at the midpoint of AIIS and IPE deep to psoas tendon. After lifting of psoas tendon by hydrolocation, the patients in PENG group will receive 1 mL of normal saline.
Real PENG blockProcedure or surgery
The regional block will be performed with the patient in the supine position in operative area with adequate groin exposure. The probe will first be placed at the anterior superior iliac spine in transverse plane, and then will be moved caudally to identify anterior inferior iliac spine (AIIS). The probe will be then rotated to align the AIIS and iliopubic eminence (IPE). This will reveal the iliopsoas tendon and muscle together with femoral vessels superficially. A 22-G 100-mm echogenic needle will be inserted in-plane from lateral to medial, and the tip will be kept at the midpoint of AIIS and IPE deep to psoas tendon. After lifting of psoas tendon by hydrolocation, the patients in PENG group will receive 20 ml of (0.25%) bupivacaine with 0.2 mg/mL dexamethasone that will be injected in 5 ml aliquots after negative aspiration.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | Patients will receive preoperative US-guided will receive sham PENG with an injection of just 1mL saline. Receives: Procedure: Sham PENG block |
| PENG Group | Experimental | Patients will receive preoperative US-guided will receive real PENG with an injection of 20mL of bupivacaine 0.25%+ 0.2mg/mL dexamethasone. Receives: Procedure: Real PENG block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for first request of rescue analgesia
Time to the first call for morphine rescue analgesia.
Measured: The first day after surgery
Secondary outcomes (1)
Postoperative morphine consumption
Total morphine consumption (rescue analgesia) in the first day postoperatively.
Measured: The first day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start2 Aug 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Model description
- Prospective study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Abdelkhalik Ahmed Ismaiel, Tanta University
- Investigators
- Sameh Abdelkhalik, M.D, Study director, Assistant Professor of Anesthesia and Intensive Care, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984109
- Sponsor's protocol ID
- 34582/3/21
- Status last verified
- Jun 2022
- First submitted
- 24 Jul 2021
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the study had been successfully completed, the data will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Ultrasound-guided Pericapsular Nerve Group Block (PENG) on the Postoperative Analgesia After Total Hip Arthroplasty: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04984109
- Acronym / sponsor ID
- 34582/3/21
- Conditions
- Pain, Postoperative, Opioid Overdose
- Keywords
- Hip arthroplasty, Pericapsular nerve block, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 30 Jul 2021 (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 randomized controlled study will be carried out on 60 adult patients undergoing primary total hip replacement in Tanta University Hospitals. All Patients will receive spinal anesthesia with either sham or real US-guided PENG block.
- The primary outcome will be the time to first request for rescue analgesia. The secondary outcome will be the postoperative Numeric Rating Scale (NRS) score and the total morphine consumption (rescue analgesia) in the first 24 h postoperatively.
Detailed description
- This prospective randomized double-blinded study will be carried out on 60 adult patients admitted to Tanta University Hospitals for 6 months started immediately after approval of the Institutional Ethical Committee.
- A written informed consent will be obtained from each patient. All data of patients will be confidential with secret codes and private files for each patient, all given data will be used for scientific purposes only after an explanation of the purpose of the study to all patients. - Any unexpected risks encountered during the course of the research will be cleared to the patients as well as to the ethical committee on time.
- The primary endpoint is a prolongation of the postoperative analgesia and reduction of the postoperative analgesic consumption. The study will be terminated if local anesthetic toxicity occurs and this will be announced to the participants and to the ethical committee at the time and adequate measures will be taken to resolve and avoid these risks.
- Group allocation will be done by using computer-generated software of randomization introduced into sealed opaque envelope technique. A blinded nurse, who does not participate in the study or data collection, will read the number contained in the envelope and make group assignments. All the nerve blocks will be performed by one anesthesiologist.
- Control Group: (30 patients) will receive sham PENG (just 1mL saline)
- PENG Group: (30 patients) will receive real PENG (20mL of bupivacaine 0.25% plus 0.2mg/ml dexamethasone)
Anesthetic technique:
•Preoperative assessment will be done by: History taking. Clinical examination. Laboratory investigations including complete blood count, bleeding and clotting times, APTT, liver and kidney function tests.
During the pre-anesthetic assessment, all patients will be familiarized with the Numeric Rating Scale (NRS) score.
- In the holding area, After the establishment of intravascular access by introducing an 18-gauge intravenous (IV) cannula, all the patients will be preloaded with Ringer's lactate solution (7 mL/kg).
- On arrival at operation room, Routine monitoring of heart rate by ECG, noninvasive blood pressure (NIBP), pulse oximetry will be done.
- Lumbar puncture will be performed at the level of L3-L4/L4-L5 intervertebral space with a 25-gauge spinal needle. After ensuring free flow of cerebrospinal fluid, 2 mL of hyperbaric bupivacaine solution (0.5%) (10mg)) with 0.5 mL (25 µg) fentanyl will be injected. The sensory block will be assessed by loss of sensation to pinprick test. The level of the sensory block should achieve at least a level of T10. Moreover, the motor block will be assessed by modified Bromage score till reaching at least a score of 2. (0; means the ability of the patient to move the hip, knee, and ankle, 1; means the inability of the patient to move the hip, but can move the knee and ankle, 2; means the inability of the patient to move the hip and knee, but can move the ankle, and finally 3; means the inability of the patient to move the hip, knee, and ankle). If the sensory and motor block levels will not be achieved within 20 minutes, the patient will be excluded from the study and receive general anesthesia. If the sensory and motor block will be achieved, the patient will receive an ultrasound-guided PENG block before starting the surgery.
- ThePENG block will be performed with the patient in the supine position in the operative area with adequate groin exposure. The probe will first be placed at the anterior superior iliac spine in the transverse plane, and then will be moved caudally to identify the anterior inferior iliac spine (AIIS). The probe will be then rotated to align the AIIS and iliopubic eminence (IPE). This will reveal the iliopsoas tendon and muscle together with femoral vessels superficially. A 22-G 100-mm echogenic needle will be inserted in-plane from lateral to medial, and the tip will be kept at the midpoint of AIIS and IPE deep to psoas tendon. After lifting of the psoas tendon by hydrolocation, the patients in the PENG group will receive 20 ml of (0.25%) bupivacaine with 0.2 mg/ml dexamethasone that will be injected in 5 ml aliquots after negative aspiration.The control group will receive 1 mL of normal saline.
- After completion of the surgical procedure, a patient will be transferred to Post-Anesthesia Care Unit (PACU). Paracetamol 15 mg/kg IV will be administered every 6 hours after discharge to the ward.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective study
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Procedure: Sham PENG blockPatients will receive preoperative US-guided will receive sham PENG with an injection of just 1mL saline. |
| PENG Group | Experimental | Procedure: Real PENG blockPatients will receive preoperative US-guided will receive real PENG with an injection of 20mL of bupivacaine 0.25%+ 0.2mg/mL dexamethasone. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients, aged 21-75 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled to undergo unilateral total hip replacement surgery.
Key exclusion criteria (7 listed)
- Patient refusal.
- Known hypersensitivity to local anesthetics.
- Body mass index > 35 kg /m2.
- Uncooperative or psychiatric patients.
- Infection at the injection site.
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 |
|---|---|---|
| Sham PENG blockThe regional block will be performed with the patient in the supine position in operative area with adequate groin exposure. The probe will first be placed at the anterior superior iliac spine in transverse plane, and then will be moved caudally to identify anterior inferior iliac spine (AIIS). The probe will be then rotated to align the AIIS and iliopubic eminence (IPE). This will reveal the iliopsoas tendon and muscle together with femoral vessels superficially. A 22-G 100-mm echogenic needle will be inserted in-plane from lateral to medial, and the tip will be kept at the midpoint of AIIS and IPE deep to psoas tendon. After lifting of psoas tendon by hydrolocation, the patients in PENG group will receive 1 mL of normal saline. | Procedure or surgery | Control group |
| Real PENG blockThe regional block will be performed with the patient in the supine position in operative area with adequate groin exposure. The probe will first be placed at the anterior superior iliac spine in transverse plane, and then will be moved caudally to identify anterior inferior iliac spine (AIIS). The probe will be then rotated to align the AIIS and iliopubic eminence (IPE). This will reveal the iliopsoas tendon and muscle together with femoral vessels superficially. A 22-G 100-mm echogenic needle will be inserted in-plane from lateral to medial, and the tip will be kept at the midpoint of AIIS and IPE deep to psoas tendon. After lifting of psoas tendon by hydrolocation, the patients in PENG group will receive 20 ml of (0.25%) bupivacaine with 0.2 mg/mL dexamethasone that will be injected in 5 ml aliquots after negative aspiration. | Procedure or surgery | PENG Group |
Primary outcome
Time for first request of rescue analgesia
Time frame: The first day after surgery
Time to the first call for morphine rescue analgesia.
1 secondary outcome
Postoperative morphine consumption
Time frame: The first day after surgery
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 Jul 2022.
- Individual participant dataSharing planned: Yes. Once the study had been successfully completed, the data will be shared with other researchers.
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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.
Sameh Abdelkhalik, M.D study director
Assistant Professor of Anesthesia and Intensive Care, Tanta 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 Real PENG block in people with Pain, Postoperative and Opioid Overdose, 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 7 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 Jul 2022. 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. Some participants in this study may receive a placebo. 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?
Time for first request of rescue analgesia (time frame: The first day after surgery). 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 Jul 2022.