Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04984109 |
| Other study ID # |
34582/3/21 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 2, 2021 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
June 2022 |
| Source |
Tanta University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
