Fayoum University hospita
El Fayoum Qesm, Faiyum Governorate, 63514, Egypt
Location status: Recruiting
NCT Number: NCT07442721
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
.
Interested in participating?
Request Info50 year–90 year
All sexes
Interventional
Not applicable
El Fayoum Qesm, Faiyum Governorate, 63514, Egypt
Location status: Recruiting
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
Anesthetic technique
(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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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).
Time frame: 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).
Time frame: During the first 24 hours postoperatively
cumulative amount of morphine in mg (will be consumed in the first 24 hours)will be measured
Time frame: 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.
Time frame: Intraoperative peroid
Cumulative intraoperative opioid dose, converted to Morphine Milligram Equivalents (MME) for standardized comparison between groups, administered throughout the surgical procedure
Time frame: At 24 hours postoperatively.
The incidence of inability to perform the standardized physiotherapy protocol due to pain or motor block at 24 hours postoperatively .
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Mohamed Ahmed Hamed
CONTACT
Samar Ahmed Ramadan
CONTACT
Fayoum University Hospital
Other
Sacral Erector Spinae Plane Block Versus Pericapsular Nerve Group Block For Analgesia In Hip Hemi Arthroplasty: A Randomized Comparative Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07452120
Acute Postoperative Pain, Hip Arthroplasty
Sivas, Turkey (Türkiye)
View Trial DetailsNCT07445009
Confusion, Delirium
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT01520961
Femoral Fractures, Femoral Neck Fractures
Boulogne-Billancourt, Île-de-France Region, France
View Trial DetailsNCT00921908
Hip Arthroplasty, Neurologic Manifestations
Hvidovre, Denmark
View Trial Details