Caudal Block Versus Quadratus Lumborum Plane Block in Lumbar Surgery

NCT06398600 | Completed

• 1 other identifier: M 696
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain is a common complication after lumbar spine surgery due to inherent tissue damage during surgical procedures. Many analgesic options have been explored. Opioid analgesics carry the risk of respiratory depression. Nonsteroidal anti-inflammatory drugs (NSAIDs) are popular and widely used as first-line treatment for acute pain following spinal surgery, but can provide inadequate analgesia. High doses of NSAIDs have also been linked to non-unions in spinal fusion surgery. Patient-controlled analgesia or epidural injection analgesia are usually used. One of US guided regional anesthesia methods is the ultrasound-guided caudal block that was first described by Klocke and colleagues in 2003. One of the more recent techniques that has been described recently is quadratus lumborum plane block(QLB),that is posterior abdominal wall fascial plane block first described by Blanco in 2007.In this study we will compare between analgesic effect of ultrasound guided caudal block to that of ultrasound guided quadratus lumborum plane block as well as safety of both modalities in adult patients undergoing lumbar spine fixation surgeries.

Conditions

Spondylolisthesis; Facet Joint Hypertrophy; Spinal Canal Stenosis

Outcome Measures

Primary Outcomes (1)

• Time to first rescue analgesic request.

  duration between time of introducing intervention and time of first analgesic request

  first 24 hours

Secondary Outcomes (8)

• The postoperative numerical pain rating score for 24 h

  for first 24 hours

• Total opioid consumption used in first 24 hours .

  for first 24 hours

• Intraoperative fentanyl consumption.

  during intra operative period

• Intraoperative heart rate every 15 minutes.

  during intra operative period

• Intraoperative blood pressure every 15 minutes

  during intra operative period

Study Arms (3)

Caudal block group

ACTIVE COMPARATOR

This group of patient receiving caudal block in prone position before the operation.

Procedure: Caudal

Quadratus lumborum plane block

ACTIVE COMPARATOR

This group of patient receiving quadratus lumborum plane block in prone position before the operation.

Procedure: Quadratus lumborum plane block

controlled group

NO INTERVENTION

this group of patient will not receive any blocks, only undergoing operation under general anesthesia and receive only 1 g paracetamol 30 min before end of operation

Interventions

Caudal PROCEDURE

In the prone position , linear transducer will be first positioned transversely on the middle line. The two sacral cornua appear as two hyperechoic structures ,two hyperechoic band structures are present between the two sacral cornua. The superficial is the sacrococcygeal ligament (SCL) and the deep is the dorsal surface of the sacrum. The sacral hiatus is a hypoechoic area between two band-like hyperechoic structures. In longitudinal view, the block needle will be inserted using the in plane technique .The block needle can be visualized in real time piercing the SCL entering the hiatus but cannot be visualized beyond the apex of the hiatus. It is therefore proposed to limit the extension of the needle tip beyond the tip of the sacral hiatus to 5 mm to avoid perforating the dura mater. After the needle is inserted in the caudal canal, 20 ml of 0.25% bupivacaine will be injected.

Caudal block group

Quadratus lumborum plane block PROCEDURE

The patient is placed in the prone position , under aseptic conditions with the sterile convex probe is placed in a transverse view at the triangle of the QL muscle and the middle thoracolumbar fascia. The projected needle path is advanced in-plane until the needle tip is visualized between the middle thoracolumbar fascia and the QL muscle . After confirming the location of the needle with 2-3 ml of saline and then aspiration, 20 ml of 0.25% bupivacaine is injected in this plane with confirmation by visualizing hydro dissection . the procedure is applied to the opposite side using the same dose to achieve bilateral block.

Quadratus lumborum plane block

Eligibility Criteria

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

You may qualify if:

• Adult patients (18-60 years old), of either gender undergoing elective lumbar spine fixation surgery.
• Patients with American Society of Anesthesiologists (ASA) physical status I-II.

You may not qualify if:

• Include patients who refuse.
• Patients with contraindications to regional anesthesia (eg, local infection at site of injection, coagulation abnormalities).
• Patients with spinal deformities or previous lumbar disc surgeries.
• Allergy to local anesthetics, mental disorders as well as drug abuse.
• BMI more than 35

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University hospital

El Fayoum Qesm, Faiyum Governorate, 63514, Egypt

Location

Related Publications (5)

• Klocke R, Jenkinson T, Glew D. Sonographically guided caudal epidural steroid injections. J Ultrasound Med. 2003 Nov;22(11):1229-32. doi: 10.7863/jum.2003.22.11.1229.

  PMID: 14620894 BACKGROUND

• Korgvee A, Junttila E, Koskinen H, Huhtala H, Kalliomaki ML. Ultrasound-guided quadratus lumborum block for postoperative analgesia: A systematic review and meta-analysis. Eur J Anaesthesiol. 2021 Feb 1;38(2):115-129. doi: 10.1097/EJA.0000000000001368.

  PMID: 33186305 BACKGROUND

• Chen CP, Tang SF, Hsu TC, Tsai WC, Liu HP, Chen MJ, Date E, Lew HL. Ultrasound guidance in caudal epidural needle placement. Anesthesiology. 2004 Jul;101(1):181-4. doi: 10.1097/00000542-200407000-00028.

  PMID: 15220789 BACKGROUND

• Elsharkawy H, El-Boghdadly K, Barrington M. Quadratus Lumborum Block: Anatomical Concepts, Mechanisms, and Techniques. Anesthesiology. 2019 Feb;130(2):322-335. doi: 10.1097/ALN.0000000000002524. No abstract available.

  PMID: 30688787 BACKGROUND

• 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: 15928561 BACKGROUND

MeSH Terms

Conditions

Spondylolisthesis; Spinal Stenosis

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Atef Mohamed, MD

  Faculty of medicine, Fayoum university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be achieved using computer-generated random numbering of each study patient. opaque sealed envelopes will be used and opened in the operating room by a anesthesia resident who will be blinded to the study. 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 three groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of anesthesia

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 3, 2024
• Study Start: May 3, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

EG (1)