- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07681648
Compined Lumber Longissimus Plane Block and Multifidus Longissimus Plane Block Versus Infiltration Field Block in Lumber Spine Surgery (LLP/MLP)
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
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 before surgical incision 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Aswan Governorate
-
Aswān, Aswan Governorate, Egypt, 81528
- Ayman Mohamady Eldemrdash
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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 before 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 intervention is performed by an experienced anesthesiologist as part of a standardized anesthetic protocol.
Postoperative outcomes including pain intensity, opioid consumption, recovery parameters, patient satisfaction, and adverse events are prospectively evaluated over the first 48 postoperative hours.
|
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 before 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 intervention is performed by an experienced anesthesiologist as part of a standardized anesthetic protocol.
Postoperative outcomes including pain intensity, opioid consumption, recovery parameters, patient satisfaction, and adverse events are prospectively evaluated over the first 48 postoperative hours.
Participants receive an ultrasound-guided bilateral combined Lumbar Longissimus Plane (LLP) and Multifidus Longissimus Plane (MLP) block after induction of general anesthesia and before 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 the dorsal rami of the lumbar spinal nerves by targeting both the intermediate and medial branches.
Unlike conventional wound infiltration, which provides localized analgesia at wound closure, this pre-incisional regional anesthesia technique aims to provide targeted, opioid-sparing postoperative analgesia as part of a multimodal analgesic strategy for elective lumbar spine surgery
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 ultrasound-guided combined LLP and MLP block.
|
|
Active Comparator: Conventional Wound Infiltration with Bupivacaine
Participants assigned to this arm receive conventional surgical wound infiltration with 40 mL of 0.25% bupivacaine at the completion of surgery and immediately before wound closure.
The local anesthetic is infiltrated by the operating surgeon into the wound margins, paraspinal muscles, periosteal tissues, and subcutaneous layers using a standard layered infiltration technique.
All participants receive the same standardized general anesthetic and postoperative analgesic regimen as the experimental group.
Postoperative pain, rescue opioid requirements, recovery outcomes, patient satisfaction, and adverse events are assessed during the 48-hour follow-up period.
|
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 before 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 intervention is performed by an experienced anesthesiologist as part of a standardized anesthetic protocol.
Postoperative outcomes including pain intensity, opioid consumption, recovery parameters, patient satisfaction, and adverse events are prospectively evaluated over the first 48 postoperative hours.
Participants receive an ultrasound-guided bilateral combined Lumbar Longissimus Plane (LLP) and Multifidus Longissimus Plane (MLP) block after induction of general anesthesia and before 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 the dorsal rami of the lumbar spinal nerves by targeting both the intermediate and medial branches.
Unlike conventional wound infiltration, which provides localized analgesia at wound closure, this pre-incisional regional anesthesia technique aims to provide targeted, opioid-sparing postoperative analgesia as part of a multimodal analgesic strategy for elective lumbar spine surgery
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 ultrasound-guided combined LLP and MLP block.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Postoperative pain intensity will be assessed at rest using a 10-cm Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents the worst imaginable pain.
Pain scores will be recorded by a blinded outcome assessor at 1, 2, 4, 8, 12, 24, and 48 hours after surgery.
The primary analysis will compare postoperative pain trajectories between the ultrasound-guided bilateral combined Lumbar Longissimus Plane (LLP) and Multifidus Longissimus Plane (MLP) block group and the conventional wound infiltration group over the first 48 postoperative hours.
|
From 1 hour to 48 hours after surgery (assessed at 1, 2, 4, 8, 12, 24, and 48 postoperative hours).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Rescue Nalbuphine Consumption
Time Frame: From the end of surgery to 48 hours postoperatively.
|
Total cumulative intravenous nalbuphine administered for rescue analgesia during the first 48 postoperative hours.
Rescue nalbuphine (5 mg IV) is administered whenever the Visual Analogue Scale (VAS) pain score is ≥4.
Total opioid consumption will be compared between the study groups.
|
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.
|
Time elapsed from completion of surgery until the first administration of rescue nalbuphine.
Patients not requiring rescue analgesia during the 48-hour follow-up will be censored for survival analysis.
|
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.
|
The occurrence and severity of postoperative nausea and vomiting will be recorded during the postoperative period.
The requirement for rescue antiemetic therapy will also be documented and compared between groups.
|
During the first 48 hours after surgery.
|
|
Patient Satisfaction with Postoperative Pain Management
Time Frame: At 24 and 48 hours after surgery.
|
Patient satisfaction with postoperative pain management will be assessed using a four-point ordinal scale ranging from very dissatisfied to very satisfied.
Scores will be compared between the study groups.
|
At 24 and 48 hours after surgery.
|
|
Time to First Mobilization
Time Frame: Within the first 48 hours after surgery.
|
Time from the completion of surgery until the patient achieves first assisted ambulation according to the standardized postoperative rehabilitation protocol.
|
Within the first 48 hours after surgery.
|
|
Length of Hospital Stay
Time Frame: From surgery until hospital discharge (approximately 2-3 days).
|
Total duration of hospitalization measured from the day of surgery until hospital discharge according to institutional discharge criteria.
|
From surgery until hospital discharge (approximately 2-3 days).
|
|
Incidence of Block-Related Adverse Events
Time Frame: From intervention until 48 hours after surgery.
|
The occurrence of block-related complications, including local anesthetic systemic toxicity, hematoma, neurological deficit, infection, or other procedure-related adverse events, will be recorded throughout the study follow-up.
|
From intervention until 48 hours after surgery.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1135/7/25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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