Postoperative Pain After Spinal SurgeryPhase 4LLP/MLPNCT07681648
Compined Lumber Longissimus Plane Block and Multifidus Longissimus Plane Block Versus Infiltration Field Block in Lumber Spine Surgery
A Phase 4 study testing Ultrasound-Guided Bilateral Combined LLP and MLP Block, [Ultrasound-Guided Bilateral Combined LLP and MLP Block] and [Conventional Wound Infiltration with Bupivacaine] in people with Postoperative Pain After Spinal Surgery, run by Engy Emil at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain After Spinal Surgery
- What is being tested?
- Ultrasound-Guided Bilateral Combined LLP and MLP Block, [Ultrasound-Guided Bilateral Combined LLP and MLP Block] and [Conventional Wound Infiltration with Bupivacaine]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Jul 2026to 20 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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.
- Conditions
- Postoperative Pain After Spinal Surgery
- Being tested
- Ultrasound-Guided Bilateral Combined LLP and MLP Block, [Ultrasound-Guided Bilateral Combined LLP and MLP Block], [Conventional Wound Infiltration with Bupivacaine]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Bilateral Combined LLP and MLP BlockDrug
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 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.
[Ultrasound-Guided Bilateral Combined LLP and MLP Block]Drug
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 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 regional anesthesia technique aims to provide targeted, opioid-sparing postoperative analgesia as part of a multimodal analgesic strategy for elective lumbar spine surgery
[Conventional Wound Infiltration with Bupivacaine]Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-Guided Bilateral Combined LLP and MLP Block | Experimental | 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 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. Receives: Drug: Ultrasound-Guided Bilateral Combined LLP and MLP Block; Drug: [Ultrasound-Guided Bilateral Combined LLP and MLP Block]; Drug: [Conventional Wound Infiltration with Bupivacaine] |
| Conventional Wound Infiltration with Bupivacaine | Active comparator | 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. Receives: Drug: Ultrasound-Guided Bilateral Combined LLP and MLP Block; Drug: [Ultrasound-Guided Bilateral Combined LLP and MLP Block]; Drug: [Conventional Wound Infiltration with Bupivacaine] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity Assessed by the Visual Analogue Scale (VAS)
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.
Measured: From 1 hour to 48 hours after surgery (assessed at 1, 2, 4, 8, 12, 24, and 48 postoperative hours).
Secondary outcomes (7)
Total Rescue Nalbuphine Consumption
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.
Measured: From the end of surgery to 48 hours postoperatively.
Time to First Rescue Analgesic Request
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.
Measured: From completion of surgery until 48 hours postoperatively.
Incidence and Severity of Postoperative Nausea and Vomiting (PONV)
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.
Measured: During the first 48 hours after surgery.
Patient Satisfaction with Postoperative Pain Management
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.
Measured: At 24 and 48 hours after surgery.
Time to First Mobilization
Time from the completion of surgery until the patient achieves first assisted ambulation according to the standardized postoperative rehabilitation protocol.
Measured: Within the first 48 hours after surgery.
Length of Hospital Stay
Total duration of hospitalization measured from the day of surgery until hospital discharge according to institutional discharge criteria.
Measured: From surgery until hospital discharge (approximately 2-3 days).
Incidence of Block-Related Adverse Events
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.
Measured: From intervention until 48 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start26 Jul 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain After Spinal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a prospective, parallel-group, patient- and assessor-blinded, randomized controlled clinical trial. Eligible adult patients undergoing elective lumbar spine surgery are randomly assigned in a 1:1 ratio to one of two intervention groups. The experimental group receives ultrasound-guided bilateral combined Lumbar Longissimus Plane (LLP) and Multifidus Longissimus Plane (MLP) blocks after closure of the wound, while the control group receives conventional wound infiltration with bupivacaine before wound closure. Randomization is performed using a computer-generated sequence with concealed allocation. Patients and postoperative outcome assessors remain blinded to treatment assignment. Outcomes are prospectively evaluated over a 48-hour postoperative follow-up to compare analgesic efficacy, opioid consumption, recovery, patient satisfaction, and safety between the two interventions.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Engy Emil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Engy Emil, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681648
- Sponsor's protocol ID
- 1135/7/25
- Acronym
- LLP/MLP
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 42017149
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07681648
- Acronym / sponsor ID
- LLP/MLP / 1135/7/25
- Conditions
- Postoperative Pain After Spinal Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Engy EmilUniversity, hospital or other
- Study start
- 26 Jul 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a prospective, parallel-group, patient- and assessor-blinded, randomized controlled clinical trial. Eligible adult patients undergoing elective lumbar spine surgery are randomly assigned in a 1:1 ratio to one of two intervention groups. The experimental group receives ultrasound-guided bilateral combined Lumbar Longissimus Plane (LLP) and Multifidus Longissimus Plane (MLP) blocks after closure of the wound, while the control group receives conventional wound infiltration with bupivacaine before wound closure. Randomization is performed using a computer-generated sequence with concealed allocation. Patients and postoperative outcome assessors remain blinded to treatment assignment. Outcomes are prospectively evaluated over a 48-hour postoperative follow-up to compare analgesic efficacy, opioid consumption, recovery, patient satisfaction, and safety between the two interventions.
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-Guided Bilateral Combined LLP and MLP Block | Experimental | Drug: Ultrasound-Guided Bilateral Combined LLP and MLP Block, Drug: [Ultrasound-Guided Bilateral Combined LLP and MLP Block], Drug: [Conventional Wound Infiltration with Bupivacaine]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 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. |
| Conventional Wound Infiltration with Bupivacaine | Active comparator | Drug: Ultrasound-Guided Bilateral Combined LLP and MLP Block, Drug: [Ultrasound-Guided Bilateral Combined LLP and MLP Block], Drug: [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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-Guided Bilateral Combined LLP and MLP BlockParticipants 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 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. | Drug | Conventional Wound Infiltration with Bupivacaine, Ultrasound-Guided Bilateral Combined LLP and MLP Block |
| [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 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 regional anesthesia technique aims to provide targeted, opioid-sparing postoperative analgesia as part of a multimodal analgesic strategy for elective lumbar spine surgery | Drug | Conventional Wound Infiltration with Bupivacaine, Ultrasound-Guided Bilateral Combined LLP and MLP Block |
| [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 ultrasound-guided combined LLP and MLP block. | Drug | Conventional Wound Infiltration with Bupivacaine, Ultrasound-Guided Bilateral Combined LLP and MLP Block |
Primary outcome
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.
7 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Results publication: PubMed 42017149Sezerano 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ultrasound-Guided Bilateral Combined LLP and MLP Block, [Ultrasound-Guided Bilateral Combined LLP and MLP Block] and [Conventional Wound Infiltration with Bupivacaine] in people with Postoperative Pain After Spinal Surgery, run by Engy Emil at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07681648, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.