Ultrasound-guided PENG Block in Total Hip Replacement
Condition: Pain, Postoperative; Opioid Overdose
MeSH terms: Pain, Postoperative; Opiate Overdose
Study type: Interventional

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.
    

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.
    

Intervention name(s): Sham PENG block; Real PENG block
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Hip arthroplasty; Pericapsular nerve block; Pain