SEQ Block for Perioperative Analgesia in Acetabular Surgery

NCT04688814 | Completed Phase 3 DMC

• 1 other identifier: 0304884
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The study will evaluate ultrasound guided SEQ block: single puncture combined lumbar erector spinae plane block and paraspinous sagittal shift (PSSS) quadratus lumborum block when compared with conventional intravenous morphine analgesia in patients undergoing posterior column acetabular fracture surgery

Conditions

Anesthesia, Local; Nerve Pain; Pain, Postoperative; Acetabular Fracture

Outcome Measures

Primary Outcomes (1)

• Total postoperative morphine consumption

  Compare the total postoperative opioid (morphine) consumption after posterior column acetabular surgery when providing ultrasound guided SEQ block: single puncture combined lumbar erector spinae plane block and paraspinous sagittal shift (PSSS) quadratus lumborum block versus conventional intravenous morphine analgesia. Morphine 0.05 mg/kg will be given intravenously when VAS score is ≥ 4. The total postoperative morphine consumption in milligrams will be recorded.

  24 hours postoperatively

Secondary Outcomes (4)

• Heart rate (HR)

  24 hours

• Mean arterial blood pressure (MABP)

  24 hours

• Resting and dynamic visual analogue score

  24 hours

• Postoperative complications

  24 hours

Study Arms (2)

Morphine Group

ACTIVE COMPARATOR

Patients will receive GA and analgesia will be based on opioids mainly intravenous morphine. Intravenous morphine in a dose of 0.05 mg/kg will be given as a rescue analgesic when the VAS ≥4 postoperatively for 24 hours

Drug: Morphine Sulfate

SEQ group

EXPERIMENTAL

Patients will receive ultrasound guided SEQ block preoperatively before the induction of general anaesthesia. Twenty five ml of 0.25 % bupivacaine will be given in the QL plane and 25 ml of the same concentration will be given in the erector spine plane

Procedure: Single puncture combined lumbar erector spinae plane block and quadrates lumborum block

Interventions

Single puncture combined lumbar erector spinae plane block and quadrates lumborum block PROCEDURE

Patients will lay laterally with the fracture side independent, a curvilinear transducer will be placed in a parasagittal plane 3-4 cm lateral to the lumbar spinous process of L4.The probe is shifted slowly to the lateral side till the transverse processes disappear. After subcutaneous local infiltration with lidocaine 1% at the cephalic end of the probe, the block needle is advanced through the erector spinae and QL muscles, until it pierces the epimysium of the QL muscle. LA is injected anterior to the QL, between the QL and psoas muscles. Then the caudal end of the probe is rotated slowly medially towards lumbar spine till the transverse process of L4 appears in the ultrasound image. The needle is withdrawn to subcutaneous tissue, then advanced in plane towards transverse process of L4. After contacting it, LA is deposited between transverse process and overlying ESM.

Also known as: SEQ group

SEQ group

Morphine Sulfate DRUG

Patients will receive GA and analgesia will be based on opioids mainly intravenous morphine

Also known as: MOR group

Morphine Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I-III patients
• Unilateral posterior wall/column acetabular fractures surgery using posterior approach

You may not qualify if:

• BMI \> 35 kg/m2
• Pre-existing neurological deficit
• Spine deformity
• Pregnancy/lactation
• Significant renal impairment
• Significant Hepatic impairment
• Known contraindications to peripheral nerve block (coagulopathy or infection at the site of injection)
• Chronic opioid users/abusers

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria Faculty of Medicine

Alexandria, 21651, Egypt

Location

Related Publications (1)

• Chelly JE, Casati A, Al-Samsam T, Coupe K, Criswell A, Tucker J. Continuous lumbar plexus block for acute postoperative pain management after open reduction and internal fixation of acetabular fractures. J Orthop Trauma. 2003 May;17(5):362-7. doi: 10.1097/00005131-200305000-00007.

  PMID: 12759641 BACKGROUND

MeSH Terms

Conditions

Neuralgia; Pain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Moustafa A Moustafa, Professor

  Alexandria Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blinded
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anaesthesia and Surgical Intensive Care

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 30, 2020
• Study Start: December 25, 2020
• Primary Completion: December 25, 2021
• Study Completion: February 15, 2022
• Last Updated: March 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will become available after 1 year for one year
• Access Criteria: Via mail of the principal investigator

Locations

EG (1)