Health TrialsbyHealthPanel

Sacral ESPB vs. PENG Block for Hip Hemiarthroplasty Analgesia

ConditionsHip ArthroplastyHip Fracture SurgeriesFemoral Neck FracturesPostoperative Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-90
SponsorFayoum University Hospital

About this trial

Sacral erector spinae plane block(S-ESPB) has been recently described. Case reports are showing that it is useful in various types of surgery. In case presentations, it has been reported as effective in providing analgesia in the posterior branches of the sacral nerves in pilonidal sinus surgery, in the treatment of radicular pain at the L5 - S1 level, after a sex reassignment operation and hypospadias surgery, and its use in combination with lumbar ESPB for analgesia was reported after hip prosthesis surgery . Described in 2018, pericapsular nerve group (PENG) block selectively targets the articular branches of the femoral and accessory obturator nerves thereby providing potential motorsparing analgesia for hip surgery

. Recent studies found that PENG block targets the articular branches of the femoral and accessory obturator nerves, only anesthetizes the anterior hip joint sparing posterior part , as well as there was a motor impairment after block which is from local anesthetic (LA) diffusion to the femoral nerve

. Motor-sparing regional anesthesia techniques have emerged as a safer alternative, balancing effective pain relief with the preservation of quadriceps function . These techniques align with Enhanced Recovery After Surgery (ERAS) protocols, which emphasize multimodal pain control, opioid minimization, and early mobility to reduce complications such as venous thromboembolism (VTE) and postoperative pneumonia

.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with ages from 50 to 90 years of either gender, with diagnosis of intracapsular neck of femur fracture scheduled for elective hip hemiarthroplasty • Patients with an American Society of Anesthesiologists (ASA) physical status I to III.

Disqualifiers

• Patient refusal.

Allergy to local anesthetics and patient with infection at the injection site of block

Patient with contraindication to spinal anesthesia.

Coagulopathy as INR≥1.5 or platelets ≤80*103 / microliter)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sacral erector spinae plane block

    Procedure/Surgery

    the curvilinear transducer of ultrasound will be placed parallel to the median sacral crest pointing towards the caudal direction. After visualizing the S1 median sacral crest, the transducer will be shifted caudally. When the S2 level will be reached, the transducer will be moved 3-4 cm laterally. Then, the intermediate crest (IC) will be detected in the parasagittal plane. At the S2-3 level, a 22-gauge Quincke spinal needle,90 mm in length will be advanced in the caudo-cranial direction under the erector spinae muscle but superficial to the transverse process at the sacral level and achieving bone contact (at depth from 3cm to 5cm according to subcutaneous tissue thickness and muscle mass). Then local anesthetic (LA)(0.5mL/kg of bupivacaine 0.25%) will be injected following negative aspiration ensuring that total administered dose remains below toxicity threshold(150mg). The correct spread is confirmed by visualizing LA separating the erector spinae muscle from the underlying bone.

  • PENG block

    Procedure/Surgery

    The ultrasound transducer will be placed in a transverse orientation, medial and caudal to the anterosuperior iliac spine in order to identify the anteroinferior iliac spine, the iliopubic eminence and the psoas tendon. Using an in-plane technique and a lateral-to-medial direction, a 22-gauge Quincke spinal needle,90 mm in length will be advanced until its tip will be positioned on the periosteum dorsal to the psoas tendon (3-5cm from the skin). The local anesthetic (0.5mL/kg of bupivacaine 0.25%) will be injected following negative aspiration ensuring that total administered dose remains below toxicity threshold(150mg). The accurate position of the needle will be confirmed by hydro dissection and spread under the ilio-psoas muscle. To avoid femoral nerve involvement, and therefore quadriceps weakness ,the investigator will perform lateral needle placement (away from the undersurface of the iliopsoas tendon), also lower volume is needed, slower injection.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: S groupActive comparator 1 intervention
Group B: G groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Numerical pain rating score (NPRS) after surgery at rest.

Numerical Pain Rating Scale (NPRS) is a subjective measure where patients rate their pain on an 11-point numerical scale. The scale ranges from 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain." Higher scores indicate a worse outcome (greater pain intensity).

Time frame
At twelve hours postoperatively

Secondary outcomes

1

Numerical Pain Rating Scale(NPRS) during movement and at rest in 24 h after surgery at (2,4,6,8,12,18,24)

NPRS (Numerical Pain Rating Scale) is assessed during movement and at rest at 2, 4, 6, 8, 12, 18, and 24 hours after surgery. The scale ranges from 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain." Higher scores indicate a worse outcome (greater pain intensity).

Time frame
At 2, 4, 6, 8, 12, 18, and 24 hours postoperatively.
2

Cumulative morphine consumption in 24 hours in mg

cumulative amount of morphine in mg (will be consumed in the first 24 hours)will be measured

Time frame
During the first 24 hours postoperatively
3

Time for first rescue analgesia (hours), standard rescue analgesia (Morphine PCA or IV (dose specified)

The time from the end of surgery until the first request for rescue analgesia (provided as Morphine PCA or IV) during the first 24 hours postoperatively.

Time frame
In the first 24 hours postoperatively
4

Intraoperative opioids consumption.

Cumulative intraoperative opioid dose, converted to Morphine Milligram Equivalents (MME) for standardized comparison between groups, administered throughout the surgical procedure

Time frame
Intraoperative peroid

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fayoum University Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now