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Enrolling by invitation NCT07681648

Compined Lumber Longissimus Plane Block and Multifidus Longissimus Plane Block Versus Infiltration Field Block in Lumber Spine Surgery

Phase IV Interventional Postoperative Pain After Spinal Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound-Guided Bilateral Combined LLP and MLP Block, [Ultrasound-Guided Bilateral Combined LLP and MLP Block], [Conventional Wound Infiltration with Bupivacaine].
Who it may be relevant to
Registry conditions: Postoperative Pain After Spinal Surgery. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Efficacy of Combined Ultrasound-Guided Bilateral Lumbar Longissimus Plane Block and Multifidus Longissimus Plane Block Versus Conventional Wound Infiltration for Postoperative Analgesia in Elective Lumbar Spine Surgery: A Prospective, Patient and Assessor Blinded, Randomized Clinical Trial

Overview

Lumbar spine surgery is one of the most commonly performed procedures for degenerative spinal disorders, including lumbar disc herniation, spinal stenosis, and degenerative disc disease. Despite continuous advances in surgical techniques, anesthesia, and perioperative care, postoperative pain remains a major clinical challenge. Severe pain during the early postoperative period may impair respiratory function, delay ambulation, prolong hospitalization, reduce patient satisfaction, and increase the risk of chronic postsurgical pain and persistent opioid use. Consequently, optimizing postoperative analgesia has become a fundamental objective of contemporary perioperative care and Enhanced Recovery After Surgery (ERAS) protocols for spine surgery. Current evidence strongly supports multimodal analgesia as the preferred strategy for postoperative pain management. This approach combines different analgesic modalities to improve pain control while minimizing opioid consumption and opioid-related adverse effects such as postoperative nausea and vomiting (PONV), sedation, respiratory depression, ileus, urinary retention, and delayed recovery. Among the available regional anesthesia techniques, ultrasound-guided paraspinal fascial plane blocks have recently gained considerable attention because they provide targeted blockade of the dorsal rami of the lumbar spinal nerves with minimal invasiveness and an excellent safety profile. Local anesthetic wound infiltration remains one of the most widely used analgesic techniques after lumbar spine surgery because it is technically simple, inexpensive, and familiar to surgeons. However, its analgesic efficacy may be limited by restricted distribution of the local anesthetic and inadequate coverage of deeper pain-generating structures. Consequently, increasing interest has focused on ultrasound-guided interfascial plane blocks capable of producing broader and more consistent analgesia. Previous investigations have mainly evaluated thoracolumbar interfascial plane (TLIP) block, modified TLIP block, and erector spinae plane block (ESPB), all of which have demonstrated encouraging reductions in postoperative pain scores and opioid requirements. Nevertheless, evidence regarding the combined use of Lumbar Longissimus Plane (LLP) block and Multifidus Longissimus Plane (MLP) block remains scarce. The LLP block targets the interfascial plane between the iliocostalis and longissimus muscles, whereas the MLP block targets the plane between the longissimus and multifidus muscles. From an anatomical perspective, combining both techniques may allow wider spread of local anesthetic around the medial and intermediate branches of the dorsal rami, potentially producing more comprehensive posterior lumbar analgesia than either single-plane block or conventional wound infiltration. However, this hypothesis has not previously been adequately evaluated in randomized clinical trials. The present study was therefore designed as a prospective, patient- and assessor-blinded, parallel-group randomized controlled trial to compare ultrasound-guided bilateral combined LLP and MLP blocks with conventional wound infiltration in adult patients undergoing elective lumbar spine surgery under general anesthesia. Fifty ASA physical status I-II patients were randomly allocated to receive either bilateral ultrasound-guided combined LLP and MLP blocks after wound closure or standard wound infiltration with bupivacaine before wound closure. The primary outcome was postoperative pain intensity measured using the Visual Analogue Scale (VAS) during the first 48 postoperative hours. Secondary outcomes included postoperative opioid requirements, time to first rescue analgesic request, postoperative nausea and vomiting, antiemetic consumption, patient satisfaction, time to first mobilization, hospital length of stay, and the incidence of block-related adverse events and local anesthetic systemic toxicity. The study was conducted at the Department of Anaesthesia, Surgical Intensive Care, and Pain Management, Aswan University Hospital, Faculty of Medicine, Aswan University, Egypt. Ethical approval was obtained before patient enrollment, and the trial was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines, and the CONSORT 2010 statement. By investigating a novel combination of two ultrasound-guided paraspinal fascial plane blocks, this trial aims to expand the evidence base for opioid-sparing regional anesthesia techniques and provide clinically relevant data that may support future multimodal analgesic protocols and larger multicenter randomized studies in lumbar spine surgery.

Interventions

  • Drug Ultrasound-Guided Bilateral Combined LLP and MLP Block
    Participants assigned to this arm receive ultrasound-guided bilateral combined Lumbar Longissimus Plane (LLP) and Multifidus Longissimus Plane (MLP) blocks following induction of general anesthesia and after closure of surgical incision. Under aseptic conditions and ultrasound guidance, 10 mL of 0.25% bupivacaine is injected into the iliocostalis-longissimus plane and an additional 10 mL into the longissimus-multifidus plane on each side, for a total of 40 mL of 0.25% bupivacaine. The interventi
  • Drug [Ultrasound-Guided Bilateral Combined LLP and MLP Block]
    Participants receive an ultrasound-guided bilateral combined Lumbar Longissimus Plane (LLP) and Multifidus Longissimus Plane (MLP) block after induction of general anesthesia and after closure of surgical incision. Under real-time ultrasound guidance, 10 mL of 0.25% bupivacaine is injected into the iliocostalis-longissimus plane and 10 mL into the longissimus-multifidus plane on each side, providing a total of 40 mL. This novel dual-plane fascial block is designed to achieve broader blockade of
  • Drug [Conventional Wound Infiltration with Bupivacaine]
    Participants receive conventional wound infiltration with 40 mL of 0.25% bupivacaine administered by the operating surgeon immediately before wound closure. The local anesthetic is infiltrated into the wound margins, paraspinal muscles, periosteum, and subcutaneous tissues using a standard layered technique. This intervention represents the institution's conventional postoperative analgesic practice and serves as the active comparator for evaluating the analgesic efficacy and safety of the ultra

Primary outcome measures

  • Postoperative Pain Intensity Assessed by the Visual Analogue Scale (VAS) [Time frame: From 1 hour to 48 hours after surgery (assessed at 1, 2, 4, 8, 12, 24, and 48 postoperative hours).]
Secondary outcome measures (7)
  • Total Rescue Nalbuphine Consumption [Time frame: From the end of surgery to 48 hours postoperatively.]
  • Time to First Rescue Analgesic Request [Time frame: From completion of surgery until 48 hours postoperatively.]
  • Incidence and Severity of Postoperative Nausea and Vomiting (PONV) [Time frame: During the first 48 hours after surgery.]
  • Patient Satisfaction with Postoperative Pain Management [Time frame: At 24 and 48 hours after surgery.]
  • Time to First Mobilization [Time frame: Within the first 48 hours after surgery.]
  • Length of Hospital Stay [Time frame: From surgery until hospital discharge (approximately 2-3 days).]
  • Incidence of Block-Related Adverse Events [Time frame: From intervention until 48 hours after surgery.]

Eligibility criteria

Inclusion criteria

Adults aged 18-65 years. Either sex. American Society of Anesthesiologists (ASA) physical status I-II. Scheduled for elective lumbar spine surgery under general anesthesia. Diagnosis of lumbar disc herniation, lumbar spinal stenosis, or degenerative disc disease requiring surgical intervention.

Ability to understand the study procedures and provide written informed consent.

Exclusion criteria

Chronic opioid use or opioid dependence. Known hypersensitivity or allergy to amide local anesthetics (e.g., bupivacaine).

Previous lumbar spine surgery at the intended operative level. Pre-existing major neurological deficits. Active infection at the planned needle insertion site. Coagulopathy or ongoing anticoagulant therapy contraindicating regional anesthesia.

Pregnancy or lactation. Severe hepatic, renal, or uncontrolled systemic disease. Body mass index (BMI) >35 kg/m² or anatomical conditions preventing ultrasound-guided block placement.

Refusal or inability to provide written informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Ayman Mohamady Eldemrdash — Aswān

Publications

  • Sezerano ML, Niyonkuru E. Personalized Multimodal and Opioid-Sparing Analgesia for Postoperative Pain Management: Enhancing Recovery and Addressing the Post-Discharge Gap. J Pain Res. 2026 Apr 16;19:597049. doi: 10.2147/JPR.S597049. eCollection 2026. PMID 42017149

Identifiers

NCT: NCT07681648 · 1135/7/25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗