NCT07442721

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 .

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
14mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Feb 2026Aug 2027

Study Start

First participant enrolled

February 1, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

1.4 years

First QC Date

February 19, 2026

Last Update Submit

February 28, 2026

Conditions

Outcome Measures

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).

    At twelve hours postoperatively

Secondary Outcomes (10)

  • 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.

  • Cumulative morphine consumption in 24 hours in mg

    During the first 24 hours postoperatively

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

    In the first 24 hours postoperatively

  • Intraoperative opioids consumption.

    Intraoperative peroid

  • Inability to perform physiotherapy at 24 hours.

    At 24 hours postoperatively.

  • +5 more secondary outcomes

Study Arms (2)

S group

ACTIVE COMPARATOR

This group will receive sacral erector spinae plane block in the operating room, after spinal anesthesia and before skin incision, when the patient will be in the lateral decubitus position, aseptic conditions will be provided for the block.

Procedure: Sacral erector spinae plane block

G group

ACTIVE COMPARATOR

This group will receive PENG Block in the operating room, after spinal anesthesia and before skin incision. Patients will be placed in the supine position, aseptic conditions will be provided for the block.

Procedure: PENG block

Interventions

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.

S group
PENG blockPROCEDURE

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.

G group

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fayoum University hospita

El Fayoum Qesm, Faiyum Governorate, 63514, Egypt

RECRUITING

Related Publications (19)

  • Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.

    PMID: 2240918BACKGROUND
  • Johnson C. Measuring Pain. Visual Analog Scale Versus Numeric Pain Scale: What is the Difference? J Chiropr Med. 2005 Winter;4(1):43-4. doi: 10.1016/S0899-3467(07)60112-8.

    PMID: 19674646BACKGROUND
  • Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29.

    PMID: 15928561BACKGROUND
  • Studzinska D, Pabjanczyk I, Polok K, Szczeklik W. Perioperative utilization of tranexamic acid in total knee and hip arthroplasty procedures in Poland - a survey-based study. Anaesthesiol Intensive Ther. 2024;56(3):206-207. doi: 10.5114/ait.2024.142670. No abstract available.

    PMID: 39451168BACKGROUND
  • Kutnik P, Bierut M, Rypulak E, Trwoga A, Wroblewska K, Marzeda P, Kosmider K, Kamieniak M, Pajak A, Wolanin N, Gebska-Wolinska M, Borys M. The use of the ERAS protocol in malnourished and properly nourished patients undergoing elective surgery: a questionnaire study. Anaesthesiol Intensive Ther. 2023;55(5):330-334. doi: 10.5114/ait.2023.134190.

    PMID: 38282499BACKGROUND
  • Lavand'homme PM, Kehlet H, Rawal N, Joshi GP; PROSPECT Working Group of the European Society of Regional Anaesthesia and Pain Therapy (ESRA). Pain management after total knee arthroplasty: PROcedure SPEcific Postoperative Pain ManagemenT recommendations. Eur J Anaesthesiol. 2022 Sep 1;39(9):743-757. doi: 10.1097/EJA.0000000000001691. Epub 2022 Jul 20.

    PMID: 35852550BACKGROUND
  • Luo D, Wan X, Liu J, Tong T. Optimally estimating the sample mean from the sample size, median, mid-range, and/or mid-quartile range. Stat Methods Med Res. 2018 Jun;27(6):1785-1805. doi: 10.1177/0962280216669183. Epub 2016 Sep 27.

    PMID: 27683581BACKGROUND
  • Aliste J, Layera S, Bravo D, Jara A, Munoz G, Barrientos C, Wulf R, Branez J, Finlayson RJ, Tran Q. Randomized comparison between pericapsular nerve group (PENG) block and suprainguinal fascia iliaca block for total hip arthroplasty. Reg Anesth Pain Med. 2021 Oct;46(10):874-878. doi: 10.1136/rapm-2021-102997. Epub 2021 Jul 20.

    PMID: 34290085BACKGROUND
  • Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.

    PMID: 30063657BACKGROUND
  • Senthil KS, Kumar P, Ramakrishnan L. Comparison of Pericapsular Nerve Group Block versus Fascia Iliaca Compartment Block as Postoperative Pain Management in Hip Fracture Surgeries. Anesth Essays Res. 2021 Oct-Dec;15(4):352-356. doi: 10.4103/aer.aer_119_21. Epub 2022 Mar 1.

    PMID: 35422548BACKGROUND
  • Birnbaum K, Prescher A, Hessler S, Heller KD. The sensory innervation of the hip joint--an anatomical study. Surg Radiol Anat. 1997;19(6):371-5. doi: 10.1007/BF01628504.

    PMID: 9479711BACKGROUND
  • Aksu C, Gurkan Y. Sacral Erector Spinae Plane Block with longitudinal midline approach: Could it be the new era for pediatric postoperative analgesia? J Clin Anesth. 2020 Feb;59:38-39. doi: 10.1016/j.jclinane.2019.06.007. Epub 2019 Jun 13. No abstract available.

    PMID: 31203111BACKGROUND
  • Kilicaslan A, Uyel Y. Novel lumbosacral approach for erector spinae plane block (LS-ESPB) in hip surgery. J Clin Anesth. 2020 Mar;60:83-84. doi: 10.1016/j.jclinane.2019.08.040. Epub 2019 Aug 30. No abstract available.

    PMID: 31476627BACKGROUND
  • Kukreja P, Deichmann P, Selph JP, Hebbard J, Kalagara H. Sacral Erector Spinae Plane Block for Gender Reassignment Surgery. Cureus. 2020 Apr 14;12(4):e7665. doi: 10.7759/cureus.7665.

    PMID: 32419993BACKGROUND
  • Piraccini E, Antioco M, Maitan S. Ultrasound guided sacral erector spinae plane block: A useful tool for radicular pain treatment. J Clin Anesth. 2020 Feb;59:11-12. doi: 10.1016/j.jclinane.2019.06.011. Epub 2019 Jun 6. No abstract available.

    PMID: 31176955BACKGROUND
  • Tulgar S, Senturk O, Thomas DT, Deveci U, Ozer Z. A new technique for sensory blockage of posterior branches of sacral nerves: Ultrasound guided sacral erector spinae plane block. J Clin Anesth. 2019 Nov;57:129-130. doi: 10.1016/j.jclinane.2019.04.014. Epub 2019 Apr 15. No abstract available.

    PMID: 30999197BACKGROUND
  • Gerhardt M, Johnson K, Atkinson R, Snow B, Shaw C, Brown A, Vangsness CT Jr. Characterisation and classification of the neural anatomy in the human hip joint. Hip Int. 2012 Jan-Feb;22(1):75-81. doi: 10.5301/HIP.2012.9042.

    PMID: 22344482BACKGROUND
  • Langworthy MJ, Sanzone AG. Multimodal Pain Strategies Including Liposomal Bupivacaine for Isolated Acetabular Fracture Surgery. J Orthop Trauma. 2018 Aug;32 Suppl 2:S11-S15. doi: 10.1097/BOT.0000000000001228.

    PMID: 30028759BACKGROUND
  • Natrajan P, Bhat RR, Remadevi R, Joseph IR, Vijayalakshmi S, Paulose TD. Comparative Study to Evaluate the Effect of Ultrasound-Guided Pericapsular Nerve Group Block Versus Fascia Iliaca Compartment Block on the Postoperative Analgesic Effect in Patients Undergoing Surgeries for Hip Fracture under Spinal Anesthesia. Anesth Essays Res. 2021 Jul-Sep;15(3):285-289. doi: 10.4103/aer.aer_122_21. Epub 2022 Feb 7.

    PMID: 35320956BACKGROUND

MeSH Terms

Conditions

Femoral Neck FracturesPain, Postoperative

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Samar Ahmed Ramadan

CONTACT

Mohamed Ahmed Hamed

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of anesthesia, Surgical ICU and Pain management , Faculty of Medicine, Fayoum University

Study Record Dates

First Submitted

February 19, 2026

First Posted

March 2, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

March 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations