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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Sham Comparator | Patients will receive preoperative US-guided will receive sham PENG with an injection of just 1mL saline. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham PENG block | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time for first request of rescue analgesia | Time to the first call for morphine rescue analgesia. | The first day after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative morphine consumption | Total morphine consumption (rescue analgesia) in the first day postoperatively. | The first day after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sameh Abdelkhalik, M.D | Assistant Professor of Anesthesia and Intensive Care, Tanta University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Tanta | Algharbia | 31511 | Egypt |
Once the study had been successfully completed, the data will be shared with other researchers.
- Within 6 months from acceptance of publication
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000083682 | Opiate Overdose |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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Prospective study
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|
| Real PENG block | Procedure | 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. |
|
| D012816 | Signs and Symptoms |
| D062787 | Drug Overdose |
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D009293 | Opioid-Related Disorders |
| D000079524 | Narcotic-Related Disorders |
| D001523 | Mental Disorders |