Circum-Psoas Blocks Versus Combined Lumbar and Sacral Plexus Blocks in Hip Fracture Surgery

NCT05660603 | Recruiting

• 1 other identifier: 10177/13/12/2022
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Hip fracture (HF) is one of the major worldwide problems that constitute a significant mortality rate, ranging from 14- 36% in the first year after injury, and is associated with profound temporary and sometimes permanent impairment of independence and quality of life in the geriatric population. Surgical treatment is considered the best option for patients with hip fractures,s especially in the elderly, however, it is associated with moderate to severe postoperative pain. Pain is one of the main factors limiting ambulation, increasing the risk of thromboembolism by immobility and causing metabolic changes that affect other systems. Therefore, individualized pain management with the use of appropriate analgesic techniques is of paramount importance. Moreover, early intervention of rehabilitation aiming at a better postoperative recovery may reduce the length of hospital stay and return to daily. Effective pain management is one of the crucial components in enhanced recovery after surgery (ERAS). • Numerous regional anesthetic techniques have been used to provide analgesia following hip fracture surgery, including intrathecal morphine, epidural analgesia, fascia iliaca block, lumber plexus block, and sacral plexus block, however, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for hip fracture surgery. To our knowledge, there is no study done to compare circum-psoas block versus the combined lumbar and sacral plexus blocks as pre-emptive analgesia in patients undergoing hip fracture surgery under general anesthesia.

Conditions

Hip Fractures

Keywords

circum-psoas blocks; lumbar plexus block; sacral plexus block; hip fracture surgery

Outcome Measures

Primary Outcomes (1)

• Assess change of Visual analogue scale (VAS)

  On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain

  at 30 minutes, 2 hours, 4, 6,12, 24 hours postoperatively

Secondary Outcomes (2)

• Assess sensory block levels

  at 2 hours postoperatively

• Total dose of rescue analgesia

  in the first 24 hour postoperatively

Study Arms (3)

control group

PLACEBO COMPARATOR

patients will be operated on under general anesthesia

Other: control

LSP group (lumbar and sacral plexus block)

ACTIVE COMPARATOR

patients will receive ultrasound-guided combined lumbar and sacral plexus blocks with 40 ml of 0.25% of bupivacaine.

Procedure: LSP; Device: Ultrasound

CP group (circum-psoas block)

ACTIVE COMPARATOR

patients will receive ultrasound-guided circum-psoas blocks with 40 ml of 0.25% of bupivacaine.

Procedure: CP; Device: Ultrasound

Interventions

control OTHER

patients will receive standard general anesthesia

control group

LSP PROCEDURE

patients will receive standard general anesthesia followed by ultrasound-guided combined lumbar and sacral plexus blocks with 40 ml of bupivacaine 0.25%.

LSP group (lumbar and sacral plexus block)

CP PROCEDURE

patients will receive standard general anesthesia followed by ultrasound-guided circum-psoas blocks with 40 ml of bupivacaine 0.25%.

CP group (circum-psoas block)

Ultrasound DEVICE

ultrasound

CP group (circum-psoas block); LSP group (lumbar and sacral plexus block)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient acceptance.
• BMI ≤ 30 kg/m2
• ASA I-III.
• First unilateral surgery for hip fracture including femoral neck, intertrochanteric or subtrochanteric fracture.
• Patient with planned hip fracture surgery within 24-72 hours under general anesthesia.

You may not qualify if:

• Multiple trauma, multiple fractures, or pathological fractures
• Prosthetic fracture or usage of bone-cement fixation in the surgery.
• Scheduled for bilateral hip fracture surgery.
• Pre-existing neurological deficit in the lower extremity
• Contraindication for peripheral nerve block (infection at the site of needle insertion, coagulopathy, allergy to local anesthetics used)
• History of chronic pain and taking analgesics
• History of cognitive dysfunction or mental illness

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Shereen E Abd Ellatif

Zagazig, Alsharqia, 4115, Egypt

RECRUITING

Related Publications (4)

• Roche JJ, Wenn RT, Sahota O, Moran CG. Effect of comorbidities and postoperative complications on mortality after hip fracture in elderly people: prospective observational cohort study. BMJ. 2005 Dec 10;331(7529):1374. doi: 10.1136/bmj.38643.663843.55. Epub 2005 Nov 18.

  PMID: 16299013 BACKGROUND

• Bendtsen TF, Pedersen EM, Haroutounian S, Soballe K, Moriggl B, Nikolajsen L, Hasselstrom JB, Fisker AK, Strid JM, Iversen B, Borglum J. The suprasacral parallel shift vs lumbar plexus blockade with ultrasound guidance in healthy volunteers--a randomised controlled trial. Anaesthesia. 2014 Nov;69(11):1227-40. doi: 10.1111/anae.12753. Epub 2014 Jun 28.

  PMID: 24974961 BACKGROUND

• Petchara S, Paphon S, Vanlapa A, Boontikar P, Disya K. Combined Lumbar-Sacral Plexus Block in High Surgical Risk Geriatric Patients undergoing Early Hip Fracture Surgery. Malays Orthop J. 2015 Nov;9(3):28-34. doi: 10.5704/MOJ.1511.004.

  PMID: 28611906 BACKGROUND

• Li H, Shi R, Shao P, Wang Y. Evaluation of Sensory Loss Obtained by Circum-Psoas Blocks in Patients Undergoing Total Hip Replacement: A Descriptive Pilot Study. J Pain Res. 2022 Mar 29;15:827-835. doi: 10.2147/JPR.S354829. eCollection 2022.

  PMID: 35378731 BACKGROUND

MeSH Terms

Conditions

Hip Fractures

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Shereen E Abd Ellatif, MD

CONTACT

01007948840; shosh.again@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double-blinded(participants and outcome assessors)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor of anesthesia and surgical intensive care

Model Details: The patients will be divided randomly by a computer-generated randomization table into three groups : Group C :(Control group) patients will receive standard general anesthesia. Group LSP: patients will receive standard general anesthesia followed by combined lumbar and sacral plexus blocks with 40 ml of bupivacaine 0.25%. Group CP: patients will receive standard general anesthesia followed by circum-psoas block with 40 ml of bupivacaine 0.25%.

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 21, 2022
• Study Start: December 20, 2022
• Primary Completion: February 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: planned after the completion of the study and publication
• Access Criteria: contact with principal investigator

Locations

EG (1)