Hip Arthroplasty, Hip Fracture Surgeries, Femoral Neck Fractures, Postoperative Pain
Conditions
Brief summary
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 .
Detailed description
Study design This double-blinded, prospective, randomized comparative study will be conducted in Fayoum University hospital after the approval of local Institutional Ethics Committee and local institutional review board. Written informed consent will be obtained from all patients for these scientific contributions before recruitment and randomization. Randomization, Allocation Concealment and blinding Patients will be randomly allocated into one of 2 parallel groups (40 in each group) based on sample size. Randomization will be achieved using computer-generated random numbering of each study patient. Allocation concealment will be insured using Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE), prepared by a researcher not involved in patient recruitment or outcome assessment. The block tray and necessary equipment will be prepared by an independent anesthesiologist not involved in patient assessment. The patient and researcher who collects the data after the block will be blinded to the study group. All study outcomes will be evaluated by a dedicated anesthesiologist who will be blinded to the group allocation.Patients will be randomized into 2 groups. Group (S) patients who will receive sacral erector spinae plane block. Group (G) patients who will receive pericapsular nerve group block. Anesthesia procedure * The study protocol, sacral erector plane block, PENG block and the numerical pain rating score (NPRS) will be explained to each patient during the preanesthetic counselling. The (NPRS) is 11-point numeric scale ranges from 0 to 10, (where score 0 =no pain and 10 =worst pain imaginable) . * . Before the participants will be admitted in this study, the purpose and nature of the study, as well as the risk-benefit assessment will be explained to them. An informed consent will be obtained from participants. Patients will fast for about 6 to 8 hours for solid meals, for 4 hours for non-clear liquids and for 2 hours for clear liquids before surgery . Anesthetic technique * Perioperative anesthesia management will be according to our hospital routine protocol. * An intravenous cannula will be inserted in the hand and standard monitoring (noninvasive blood pressure, electrocardiography, and pulse oximetry) will be applied. * In all patients, spinal anesthesia will be performed in the sitting position. The midline at level of the L3-4 and L4-5 intervertebral spaces will be identified, and spinal anesthesia will be administered using 25-gauge Quincke needle. * Patients will be immediately placed in the supine position. Spinal anesthesia will be considered successful when a bilateral block to T12, as assessed by loss of cold (cold ice) and pain (a 23-gauge needle) sensations, will be established 10 minutes after the intrathecal injection, the surgery will be done using a lateral approach and a lateral decubitus position. Local Anesthetic Dose, Safety, and Emergency Preparedness 1. Sacral ESPB: 30 mL of 0.25% bupivacaine HCl (plain), equivalent to 75 mg. PENG block: 20 mL of 0.25% bupivacaine HCl (plain), equivalent to 50 mg . Both doses fall well within the recommended maximum safe dose for elderly patients and selected per anatomical requirements and RCT evidence. The maximum safe dose of plain bupivacaine will be strictly adhered to, defined as 2 mg/kg, not exceeding an absolute maximum of 150 mg. 2. Slow Incremental Injection: The standard practice is to inject the local anesthetic under ultrasound guidance in small boluses, commonly 5-10 mL at a time, followed by aspiration to rule out intravascular placement and systemic toxicity. 3. Emergency preparedness measures included: (i) Lipid rescue protocol availability: 20% Intralipid solution will be readily available for immediate intravenous administration in the event of local anesthetic systemic toxicity (LAST), according to ASRA guidelines. (ii) Monitoring for LAST: Continuous monitoring of neurological status (e.g., dizziness, perioral numbness, seizures) and cardiovascular parameters (ECG, blood pressure, heart rate) will be performed throughout the procedure and during the immediate post-block period. (iii) Allergic/anaphylaxis management: Emergency medications (adrenaline, antihistamines, corticosteroids) and resuscitation equipment will be available, with a predefined protocol for prompt management of any hypersensitivity reactions. (iv)Emergency airway management equipment will be available at the bed side. (V) Stop rule will be applied if unexpected adverse events (e.g., severe hypotension, arrhythmia, LA toxicity). Postoperative analgesia protocol All patients will receive standardized multimodal analgesia. Paracetamol (1 g every 6 hours) and NSAIDs (unless contraindicated) will be administered as routine analgesics. Opioids will be used as rescue medication according to a unified protocol for both groups. This standardized regimen aims to minimize confounding and ensure that differences in pain scores are attributable to the regional techniques.
Interventions
PROCEDURESacral erector spinae plane block
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.
PROCEDUREPENG block
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.
Sponsors
Fayoum University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* • 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) * Patients with body mass index\>35 kg / m2 * Patients with peripheral neuropathy or diabetic neuropathy * Patients receiving opioids for chronic analgesic therapy (cancer, addiction). * Cognitive impairment preventing pain scoring. * Chronic renal failure requiring dose modification. * Bilateral hip fracture or previous ipsilateral hip surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical pain rating score (NPRS) after surgery at rest. | At twelve hours postoperatively | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Pain Rating Scale(NPRS) during movement and at rest in 24 h after surgery at (2,4,6,8,12,18,24) | At 2, 4, 6, 8, 12, 18, and 24 hours postoperatively. | 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). |
| Cumulative morphine consumption in 24 hours in mg | During the first 24 hours postoperatively | cumulative amount of morphine in mg (will be consumed in the first 24 hours)will be measured |
| Time for first rescue analgesia (hours), standard rescue analgesia (Morphine PCA or IV (dose specified) | In the first 24 hours postoperatively | 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. |
| Intraoperative opioids consumption. | Intraoperative peroid | Cumulative intraoperative opioid dose, converted to Morphine Milligram Equivalents (MME) for standardized comparison between groups, administered throughout the surgical procedure |
| Inability to perform physiotherapy at 24 hours. | At 24 hours postoperatively. | The incidence of inability to perform the standardized physiotherapy protocol due to pain or motor block at 24 hours postoperatively . |
| Delirium assessment (CAM score), a diagnosis of delirium is made if the patient has both (Acute onset and fluctuating course) and (Inattention), plus either (Disorganized thinking) or (Altered level of f consciousness) 20 | Twice daily (every 12 hours) for the first 72 hours postoperatively. | Incidence of postoperative delirium, assessed using the Confusion Assessment Method (CAM) algorithm. A positive diagnosis requires the presence of: (1) acute onset and fluctuating course, (2) inattention, AND either (3) disorganized thinking OR (4) altered level of consciousness. |
| The incidence of block-related adverse events (ie, vascular puncture, LA toxicity). | For Vascular Puncture: "Intraoperatively, during the performance of the nerve block. For LA Toxicity (LAST): "From the time of injection until 60 minutes post-procedure. | The incidence of block-related complications, specifically accidental vascular puncture (defined as aspiration of blood during needle placement) and Local Anesthetic Systemic Toxicity (LAST) (defined by neurological or cardiovascular signs following LA injection). |
| Incidence of quadriceps motor block at 3,6,12,24 hours postoperatively | At 3, 6, 12, and 24 hours postoperatively. | Incidence of quadriceps motor block, assessed using the Medical Research Council (MRC) scale for muscle strength (0 to 5). Motor block is defined as any reduction in strength (MRC score \< 5) during active knee extension against resistance. |
| Opioid related side effects (ie, nausea, vomiting, urine retention, respiratory depression) | From the time of the first dose up to 24 hours post-administration. | Incidence of opioid-induced respiratory depression (OIRD), defined as a respiratory rate \< 8-10 breaths/minute or oxygen saturation (SpO2) \< 90% for more than 1 minute, or any other related side effects like nausea, vomiting, urine retention. |
| Length of stay in hospital. | From the day of surgery until hospital discharge, assessed up to 30 days. | The number of days from the date of surgery until the date of hospital discharge. |
Countries
Egypt
Contacts
CONTACTSamar Ahmed Ramadan
CONTACTMohamed Ahmed Hamed
Outcome results
None listed