Postoperative Pain ControlNCT07878013
Intertransverse Process Block Versus Erector Spinae Plane Block for Pain Relief in Lumbar Spine Surgery
A study testing Erector Spinae Plane Block, Intertransverse Process Block and Local anesthetic infiltration in people with Postoperative Pain Control and Lumbar Spine Surgery, run by Hanoi Medical University at 1 site in Vietnam.
Trial summary
The goal of this clinical trial is to learn whether two types of ultrasound-guided nerve block, the intertransverse process block and the erector spinae plane block, reduce pain and the need for opioid pain medicines during and after lumbar spine surgery in adults. It also compares the two blocks with each other. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain Control, Lumbar Spine Surgery, Degenerative Lumbar Spine Diseases
- What is being tested?
- Erector Spinae Plane Block, Intertransverse Process Block and Local anesthetic infiltration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Mar 2026to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Scheduled for elective lumbar spine surgery
- American Society of Anesthesiologists (ASA) physical status I or II
- Able to give written informed consent after receiving full information about the study, the analgesic methods and their potential risks.
Who cannot join
- - Acute lumbar spine trauma
- Contraindication to regional anesthesia, including infection at the needle insertion site or severe coagulopathy (INR > 1.5 or platelet count < 50 × 10^9/L)
- Previous lumbar spine surgery altering the anatomy at the planned block site
- Known allergy or hypersensitivity to any study drug
- Severe cardiovascular, respiratory, hepatic or renal disease that may affect anesthesia, analgesia or outcome assessment
- Psychiatric disorder, cognitive impairment or communication difficulty preventing understanding and use of the Visual Analogue Scale or the PCA device.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intraoperative and Postoperative Analgesic Efficacy Between Single-Injection Erector Spinae Plane Block and Intertransverse Process Block in Lumbar Spine Surgery: A Randomized Controlled Trial
The goal of this clinical trial is to learn whether two types of ultrasound-guided nerve block, the intertransverse process block and the erector spinae plane block, reduce pain and the need for opioid pain medicines during and after lumbar spine surgery in adults. It also compares the two blocks with each other.
The main questions it aims to answer are:
Read more
Do patients who receive either nerve block need less morphine in the first 24 hours after surgery than patients who receive only local anesthetic injected at the skin incision? Is there a difference between the two nerve blocks in pain scores, the amount of opioid medicine needed during and after surgery, the time until patients first ask for pain medicine, and side effects?
Researchers will compare three groups: an erector spinae plane block group, an intertransverse process block group, and a control group that receives local anesthetic infiltration at the incision site.
Participants will:
Be randomly assigned to one of the three groups before surgery Receive the nerve block on both sides of the spine with ropivacaine before general anesthesia (block groups), or local anesthetic infiltration along the planned incision after induction of anesthesia (control group) Undergo general anesthesia and lumbar spine surgery following the same standard protocol Use a patient-controlled analgesia pump that delivers morphine on demand for 24 hours after surgery Rate their pain at rest and during movement at set times over the first 24 hours, and be monitored for side effects such as nausea and vomiting
Read the detailed description
Background and rationale
Lumbar spine surgery is associated with moderate to severe postoperative pain, and opioid-based analgesia is limited by side effects such as nausea, vomiting, sedation and respiratory depression. The erector spinae plane block (ESPB) is an established component of multimodal analgesia for spine surgery. The intertransverse process block (ITPB) is a more recently described paraspinal technique in which local anesthetic is injected into the tissue between adjacent transverse processes, closer to the paravertebral space. Direct comparisons of the two techniques in lumbar spine surgery are scarce.
Block procedures
Both blocks are performed bilaterally before induction of general anesthesia, with the patient prone, under ultrasound guidance using a low-frequency curvilinear probe and an in-plane approach with a 10-cm block needle.
ESPB: the needle tip is placed between the deep surface of the erector spinae muscle and the posterior surface of the L3 transverse process.
ITPB: the needle tip is placed in the intertransverse space between the L2 and L3 transverse processes, anterior to the erector spinae muscle and posterior to the intertransverse ligament-muscle complex, without advancing further anteriorly.
Needle position is confirmed by hydrodissection with 2 mL of 0.9% saline after negative aspiration. Ropivacaine 0.375% (prepared from ropivacaine 0.5% and 0.9% saline in a 3:1 ratio) is administered at 2.5 mg/kg (maximum 150 mg), divided equally between the two sides. Sensory block is assessed by pinprick 20 minutes after injection using the Hollmén scale, and the cranial and caudal extent of the block is measured in centimetres from the injection level. A block is considered failed if no sensory change is detected 30 minutes after injection.
In the control group, after induction of anesthesia, the surgeon infiltrates 20 mL of 1% lidocaine with epinephrine 1:200,000 into the skin and subcutaneous tissue along both sides of the planned incision before skin incision.
Anesthesia protocol (all groups)
Anesthesia is induced with fentanyl 2 µg/kg, propofol 2-3 mg/kg and rocuronium 0.6 mg/kg, and maintained with sevoflurane at 1-1.5 MAC. Nociceptive response is assessed using the PRST score (blood pressure, heart rate, sweating, tearing). If PRST is ≥ 4, fentanyl 50 µg is given intravenously and may be repeated after 5 minutes. Paracetamol 1 g IV is given approximately 30 minutes before the end of surgery.
Postoperative analgesia
Once patients are awake in the recovery room and able to rate pain and use the device, intravenous morphine patient-controlled analgesia (PCA) is started: morphine 1 mg/mL, bolus 1 mg, lockout interval 8 minutes, no background infusion, maximum 15 mg per 4 hours. Patients are instructed to press the PCA button when pain is VAS ≥ 4. H0 is defined as the time the patient is awake in the recovery room and able to self-report pain and use PCA.
Sample size
Sample size was calculated for comparison of 24-hour morphine consumption between a block group and the control group, assuming a standard deviation of 6.54 mg (from a previous Vietnamese study of ESPB in lumbar spine surgery) and a minimum clinically important difference of 5 mg, with two-sided α = 0.05 and 80% power. This gave 27 patients per group; allowing for about 10% dropout, 30 patients per group (90 in total) were enrolled.
Randomization and statistical analysis
Eligible patients are randomly allocated in a 1:1:1 ratio to the three groups by drawing lots. Continuous variables are compared using one-way ANOVA or the Kruskal-Wallis test, as appropriate, and categorical variables using the chi-square or Fisher's exact test. Pairwise comparisons are adjusted with the Bonferroni method. Two-sided p < 0.05 is considered statistically significant. Analyses are performed with SPSS version 20.0.
- Being tested
- Erector Spinae Plane Block, Intertransverse Process Block, Local anesthetic infiltration, Morphine PCA
- Keywords
- Erector Spinae Plane Block, Intertransverse Process Block, Ultrasound-Guided Regional Anesthesia, Paraspinal Block, Opioid Consumption, Patient-Controlled Analgesia, Multimodal Analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
Bilateral ultrasound-guided injection of local anesthetic between the erector spinae muscle and the L3 transverse process, performed in the prone position before induction of general anesthesia.
Intertransverse Process BlockProcedure or surgery
Bilateral ultrasound-guided injection of local anesthetic into the intertransverse space between the L2 and L3 transverse processes, anterior to the erector spinae muscle and posterior to the intertransverse ligament complex, performed in the prone position before induction of general anesthesia.
Local anesthetic infiltrationProcedure or surgery
Subcutaneous infiltration along both sides of the planned skin incision by the surgeon after induction of general anesthesia and before skin incision.
Morphine PCAProcedure or surgery
Intravenous morphine 1 mg/mL via patient-controlled analgesia: 1 mg bolus, 8-minute lockout interval, no background infusion, maximum 15 mg per 4 hours, for 24 hours after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block (ESPB) | Experimental | Bilateral ultrasound-guided erector spinae plane block at the L3 transverse process before induction of general anesthesia, using ropivacaine 0.375% at 2.5 mg/kg (maximum 150 mg), divided equally between the two sides. Followed by standardized general anesthesia and intravenous morphine patient-controlled analgesia for 24 hours after surgery. Receives: Procedure: Erector Spinae Plane Block; Procedure: Morphine PCA |
| Intertransverse Process Block (ITPB) | Experimental | Bilateral ultrasound-guided intertransverse process block at the L2-L3 level before induction of general anesthesia, using ropivacaine 0.375% at 2.5 mg/kg (maximum 150 mg), divided equally between the two sides. Followed by standardized general anesthesia and intravenous morphine patient-controlled analgesia for 24 hours after surgery. Receives: Procedure: Intertransverse Process Block; Procedure: Morphine PCA |
| Control (Local Infiltration) | Active comparator | No nerve block. After induction of general anesthesia, the surgeon infiltrates 20 mL of 1% lidocaine with epinephrine 1:200,000 into the skin and subcutaneous tissue along both sides of the planned incision before skin incision. Followed by standardized general anesthesia and intravenous morphine patient-controlled analgesia for 24 hours after surgery. Receives: Procedure: Local anesthetic infiltration; Procedure: Morphine PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Morphine Consumption Within 24 Hours After Surgery
Total amount of intravenous morphine (mg) delivered by the patient-controlled analgesia (PCA) pump, including any supplemental morphine, from Hour 0 to Hour 24. Hour 0 is defined as the time the participant is awake in the recovery room and able to self-report pain and use the PCA device.
Measured: From Hour 0 (awake in the recovery room) to Hour 24 after surgery
Secondary outcomes (11)
Cumulative Morphine Consumption Within 12 Hours After Surgery
Total amount of intravenous morphine (mg) delivered by the PCA pump, including any supplemental morphine, from Hour 0 to Hour 12.
Measured: From Hour 0 (awake in the recovery room) to Hour 12 after surgery
Pain Score at Rest
Pain intensity at rest measured on a 0-10 Visual Analogue Scale (0 = no pain, 10 = worst imaginable pain). One score is recorded at each time point.
Measured: Hour 0 (awake in the recovery room), and Hours 1, 2, 4, 8, 12 and 24 after surgery
Pain Score on Movement
Pain intensity on movement measured on a 0-10 Visual Analogue Scale (0 = no pain, 10 = worst imaginable pain). At each time point, the participant is asked to cough and flex the knees, then rates the worst pain experienced during these movements as a single score.
Measured: Hour 0 (awake in the recovery room), and Hours 1, 2, 4, 8, 12 and 24 after surgery
Total Intraoperative Fentanyl Consumption
Total fentanyl dose (µg) from induction of anesthesia to the end of surgery, including the induction dose and supplemental doses given when the PRST score (blood pressure, heart rate, sweating, tearing) is 4 or higher.
Measured: From induction of anesthesia to the end of surgery
Intraoperative Heart Rate
Heart rate (beats/min)
Measured: Before induction, before intubation, after intubation, before skin incision, 5, 15, 30 and 60 minutes after skin incision, before skin closure, and 5 minutes after skin closure.
Intraoperative Mean Arterial Pressure
Mean arterial pressure (mmHg)
Measured: Before induction, before intubation, after intubation, before skin incision, 5, 15, 30 and 60 minutes after skin incision, before skin closure, and 5 minutes after skin closure
Postoperative Heart Rate
Heart rate (beats/min)
Measured: Hour 0 (awake in the recovery room), and Hours 1, 2, 4, 8, 12 and 24 after surgery
Postoperative Mean Arterial Pressure
Mean arterial pressure (mmHg)
Measured: Hour 0 (awake in the recovery room), and Hours 1, 2, 4, 8, 12 and 24 after surgery
Postoperative Respiratory Rate
Respiratory rate (breaths/min)
Measured: Hour 0 (awake in the recovery room), and Hours 1, 2, 4, 8, 12 and 24 after surgery
Postoperative Peripheral Oxygen Saturation
Peripheral oxygen saturation (%) measured by pulse oximetry
Measured: Hour 0 (awake in the recovery room), and Hours 1, 2, 4, 8, 12 and 24 after surgery
Time to First Analgesic Request
Time (minutes) from Hour 0 to the participant's first PCA demand. Participants are instructed to press the PCA button when pain is 4 or higher on the Visual Analogue Scale.
Measured: From Hour 0 (awake in the recovery room) up to Hour 24 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Mar 2026
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain ControlStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, three-arm, parallel-group trial. Patients undergoing elective lumbar spine surgery are allocated in a 1:1:1 ratio to bilateral erector spinae plane block, bilateral intertransverse process block, or local anesthetic infiltration at the incision site (control).
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878013
- Sponsor's protocol ID
- HMU_ESP_ITPB
- Status last verified
- Sep 2026
- First submitted
- 2 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in publications will be shared upon reasonable request to the principal investigator, after approval of a methodologically sound proposal and signing of a data access agreement.
Publications
Asker D, Baytar C, Baytar MS, Kurada G, Bollucuoglu K, Okyay RD, Incegul BGK, Piskin O, Ayoglu H. Intertransverse process and modified thoracolumbar interfascial plane blocks compared with conventional analgesia in lumbar disc herniation surgery: a randomized controlled trial. BMC Anesthesiol. 2026 Jul 14. doi: 10.1186/s12871-026-04094-2. Online ahead of print.
PubMed 42449236Qian L, Zhang H, Miao Y, Qu Z, Zhang Y, Hua B, Hua Z. Comparison between ultrasound-guided intertransverse process and erector spinae plane blocks for breast cancer surgery: A randomised controlled trial. Eur J Anaesthesiol. 2025 Mar 1;42(3):224-232. doi: 10.1097/EJA.0000000000002091. Epub 2024 Oct 29.
PubMed 39474710Wang CW, Zou P, Zhang ZX, Si MY, Yi QG, Zhan LF. Distribution pattern of different volumes of ropivacaine in ultrasound-guided intertransverse process block: a randomized, blinded, computed tomography imaging study. BMC Anesthesiol. 2025 Apr 5;25(1):155. doi: 10.1186/s12871-025-03017-x.
PubMed 40188337Yu X, Liu C. Intertransverse process block: A narrative review. J Clin Anesth. 2025 Jun;104:111857. doi: 10.1016/j.jclinane.2025.111857. Epub 2025 May 5.
PubMed 40328198Varela V, Ruiz C, Montecinos S, Prats-Galino A, Sala-Blanch X. Spread of local anesthetic injected in the paravertebral space, intertransverse processes space, and erector spinae plane: a cadaveric model. Reg Anesth Pain Med. 2024 Mar 4;49(3):228-232. doi: 10.1136/rapm-2023-104342.
PubMed 37607803
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intraoperative and Postoperative Analgesic Efficacy Between Single-Injection Erector Spinae Plane Block and Intertransverse Process Block in Lumbar Spine Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07878013
- Acronym / sponsor ID
- HMU_ESP_ITPB
- Keywords
- Erector Spinae Plane Block, Intertransverse Process Block, Ultrasound-Guided Regional Anesthesia, Paraspinal Block, Opioid Consumption, Patient-Controlled Analgesia, Multimodal Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 16 Oct 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.
The goal of this clinical trial is to learn whether two types of ultrasound-guided nerve block, the intertransverse process block and the erector spinae plane block, reduce pain and the need for opioid pain medicines during and after lumbar spine surgery in adults. It also compares the two blocks with each other.
The main questions it aims to answer are:
Do patients who receive either nerve block need less morphine in the first 24 hours after surgery than patients who receive only local anesthetic injected at the skin incision? Is there a difference between the two nerve blocks in pain scores, the amount of opioid medicine needed during and after surgery, the time until patients first ask for pain medicine, and side effects?
Researchers will compare three groups: an erector spinae plane block group, an intertransverse process block group, and a control group that receives local anesthetic infiltration at the incision site.
Participants will:
Be randomly assigned to one of the three groups before surgery Receive the nerve block on both sides of the spine with ropivacaine before general anesthesia (block groups), or local anesthetic infiltration along the planned incision after induction of anesthesia (control group) Undergo general anesthesia and lumbar spine surgery following the same standard protocol Use a patient-controlled analgesia pump that delivers morphine on demand for 24 hours after surgery Rate their pain at rest and during movement at set times over the first 24 hours, and be monitored for side effects such as nausea and vomiting
Detailed description
Background and rationale
Lumbar spine surgery is associated with moderate to severe postoperative pain, and opioid-based analgesia is limited by side effects such as nausea, vomiting, sedation and respiratory depression. The erector spinae plane block (ESPB) is an established component of multimodal analgesia for spine surgery. The intertransverse process block (ITPB) is a more recently described paraspinal technique in which local anesthetic is injected into the tissue between adjacent transverse processes, closer to the paravertebral space. Direct comparisons of the two techniques in lumbar spine surgery are scarce.
Block procedures
Both blocks are performed bilaterally before induction of general anesthesia, with the patient prone, under ultrasound guidance using a low-frequency curvilinear probe and an in-plane approach with a 10-cm block needle.
ESPB: the needle tip is placed between the deep surface of the erector spinae muscle and the posterior surface of the L3 transverse process.
ITPB: the needle tip is placed in the intertransverse space between the L2 and L3 transverse processes, anterior to the erector spinae muscle and posterior to the intertransverse ligament-muscle complex, without advancing further anteriorly.
Needle position is confirmed by hydrodissection with 2 mL of 0.9% saline after negative aspiration. Ropivacaine 0.375% (prepared from ropivacaine 0.5% and 0.9% saline in a 3:1 ratio) is administered at 2.5 mg/kg (maximum 150 mg), divided equally between the two sides. Sensory block is assessed by pinprick 20 minutes after injection using the Hollmén scale, and the cranial and caudal extent of the block is measured in centimetres from the injection level. A block is considered failed if no sensory change is detected 30 minutes after injection.
In the control group, after induction of anesthesia, the surgeon infiltrates 20 mL of 1% lidocaine with epinephrine 1:200,000 into the skin and subcutaneous tissue along both sides of the planned incision before skin incision.
Anesthesia protocol (all groups)
Anesthesia is induced with fentanyl 2 µg/kg, propofol 2-3 mg/kg and rocuronium 0.6 mg/kg, and maintained with sevoflurane at 1-1.5 MAC. Nociceptive response is assessed using the PRST score (blood pressure, heart rate, sweating, tearing). If PRST is ≥ 4, fentanyl 50 µg is given intravenously and may be repeated after 5 minutes. Paracetamol 1 g IV is given approximately 30 minutes before the end of surgery.
Postoperative analgesia
Once patients are awake in the recovery room and able to rate pain and use the device, intravenous morphine patient-controlled analgesia (PCA) is started: morphine 1 mg/mL, bolus 1 mg, lockout interval 8 minutes, no background infusion, maximum 15 mg per 4 hours. Patients are instructed to press the PCA button when pain is VAS ≥ 4. H0 is defined as the time the patient is awake in the recovery room and able to self-report pain and use PCA.
Sample size
Sample size was calculated for comparison of 24-hour morphine consumption between a block group and the control group, assuming a standard deviation of 6.54 mg (from a previous Vietnamese study of ESPB in lumbar spine surgery) and a minimum clinically important difference of 5 mg, with two-sided α = 0.05 and 80% power. This gave 27 patients per group; allowing for about 10% dropout, 30 patients per group (90 in total) were enrolled.
Randomization and statistical analysis
Eligible patients are randomly allocated in a 1:1:1 ratio to the three groups by drawing lots. Continuous variables are compared using one-way ANOVA or the Kruskal-Wallis test, as appropriate, and categorical variables using the chi-square or Fisher's exact test. Pairwise comparisons are adjusted with the Bonferroni method. Two-sided p < 0.05 is considered statistically significant. Analyses are performed with SPSS version 20.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized, three-arm, parallel-group trial. Patients undergoing elective lumbar spine surgery are allocated in a 1:1:1 ratio to bilateral erector spinae plane block, bilateral intertransverse process block, or local anesthetic infiltration at the incision site (control).
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block (ESPB) | Experimental | Procedure: Erector Spinae Plane Block, Procedure: Morphine PCABilateral ultrasound-guided erector spinae plane block at the L3 transverse process before induction of general anesthesia, using ropivacaine 0.375% at 2.5 mg/kg (maximum 150 mg), divided equally between the two sides. Followed by standardized general anesthesia and intravenous morphine patient-controlled analgesia for 24 hours after surgery. |
| Intertransverse Process Block (ITPB) | Experimental | Procedure: Intertransverse Process Block, Procedure: Morphine PCABilateral ultrasound-guided intertransverse process block at the L2-L3 level before induction of general anesthesia, using ropivacaine 0.375% at 2.5 mg/kg (maximum 150 mg), divided equally between the two sides. Followed by standardized general anesthesia and intravenous morphine patient-controlled analgesia for 24 hours after surgery. |
| Control (Local Infiltration) | Active comparator | Procedure: Local anesthetic infiltration, Procedure: Morphine PCANo nerve block. After induction of general anesthesia, the surgeon infiltrates 20 mL of 1% lidocaine with epinephrine 1:200,000 into the skin and subcutaneous tissue along both sides of the planned incision before skin incision. Followed by standardized general anesthesia and intravenous morphine patient-controlled analgesia for 24 hours after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Scheduled for elective lumbar spine surgery
- American Society of Anesthesiologists (ASA) physical status I or II
- Able to give written informed consent after receiving full information about the study, the analgesic methods and their potential risks.
Key exclusion criteria (6 listed)
- - Acute lumbar spine trauma
- Contraindication to regional anesthesia, including infection at the needle insertion site or severe coagulopathy (INR > 1.5 or platelet count < 50 × 10^9/L)
- Previous lumbar spine surgery altering the anatomy at the planned block site
- Known allergy or hypersensitivity to any study drug
- Severe cardiovascular, respiratory, hepatic or renal disease that may affect anesthesia, analgesia or outcome assessment
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 |
|---|---|---|
| Erector Spinae Plane BlockBilateral ultrasound-guided injection of local anesthetic between the erector spinae muscle and the L3 transverse process, performed in the prone position before induction of general anesthesia. | Procedure or surgery | Erector Spinae Plane Block (ESPB) |
| Intertransverse Process BlockBilateral ultrasound-guided injection of local anesthetic into the intertransverse space between the L2 and L3 transverse processes, anterior to the erector spinae muscle and posterior to the intertransverse ligament complex, performed in the prone position before induction of general anesthesia. | Procedure or surgery | Intertransverse Process Block (ITPB) |
| Local anesthetic infiltrationSubcutaneous infiltration along both sides of the planned skin incision by the surgeon after induction of general anesthesia and before skin incision. | Procedure or surgery | Control (Local Infiltration) |
| Morphine PCAIntravenous morphine 1 mg/mL via patient-controlled analgesia: 1 mg bolus, 8-minute lockout interval, no background infusion, maximum 15 mg per 4 hours, for 24 hours after surgery. | Procedure or surgery | Control (Local Infiltration), Erector Spinae Plane Block (ESPB), Intertransverse Process Block (ITPB) |
Primary outcome
Cumulative Morphine Consumption Within 24 Hours After Surgery
Time frame: From Hour 0 (awake in the recovery room) to Hour 24 after surgery
Total amount of intravenous morphine (mg) delivered by the patient-controlled analgesia (PCA) pump, including any supplemental morphine, from Hour 0 to Hour 24. Hour 0 is defined as the time the participant is awake in the recovery room and able to self-report pain and use the PCA device.
11 secondary outcomes
Cumulative Morphine Consumption Within 12 Hours After Surgery
Time frame: From Hour 0 (awake in the recovery room) to Hour 12 after surgery
Pain Score at Rest
Time frame: Hour 0 (awake in the recovery room), and Hours 1, 2, 4, 8, 12 and 24 after surgery
Pain Score on Movement
Time frame: Hour 0 (awake in the recovery room), and Hours 1, 2, 4, 8, 12 and 24 after surgery
Total Intraoperative Fentanyl Consumption
Time frame: From induction of anesthesia to the end of surgery
Intraoperative Heart Rate
Time frame: Before induction, before intubation, after intubation, before skin incision, 5, 15, 30 and 60 minutes after skin incision, before skin closure, and 5 minutes after skin closure.
Intraoperative Mean Arterial Pressure
Time frame: Before induction, before intubation, after intubation, before skin incision, 5, 15, 30 and 60 minutes after skin incision, before skin closure, and 5 minutes after skin closure
Postoperative Heart Rate
Time frame: Hour 0 (awake in the recovery room), and Hours 1, 2, 4, 8, 12 and 24 after surgery
Postoperative Mean Arterial Pressure
Time frame: Hour 0 (awake in the recovery room), and Hours 1, 2, 4, 8, 12 and 24 after surgery
Postoperative Respiratory Rate
Time frame: Hour 0 (awake in the recovery room), and Hours 1, 2, 4, 8, 12 and 24 after surgery
Postoperative Peripheral Oxygen Saturation
Time frame: Hour 0 (awake in the recovery room), and Hours 1, 2, 4, 8, 12 and 24 after surgery
Time to First Analgesic Request
Time frame: From Hour 0 (awake in the recovery room) up to Hour 24 after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 42449236Asker D, Baytar C, Baytar MS, Kurada G, Bollucuoglu K, Okyay RD, Incegul BGK, Piskin O, Ayoglu H. Intertransverse process and modified thoracolumbar interfascial plane blocks compared with conventional analgesia in lumbar disc herniation surgery: a randomized controlled trial. BMC Anesthesiol. 2026 Jul 14. doi: 10.1186/s12871-026-04094-2. Online ahead of print.
- Background: PubMed 39474710Qian L, Zhang H, Miao Y, Qu Z, Zhang Y, Hua B, Hua Z. Comparison between ultrasound-guided intertransverse process and erector spinae plane blocks for breast cancer surgery: A randomised controlled trial. Eur J Anaesthesiol. 2025 Mar 1;42(3):224-232. doi: 10.1097/EJA.0000000000002091. Epub 2024 Oct 29.
- Background: PubMed 40188337Wang CW, Zou P, Zhang ZX, Si MY, Yi QG, Zhan LF. Distribution pattern of different volumes of ropivacaine in ultrasound-guided intertransverse process block: a randomized, blinded, computed tomography imaging study. BMC Anesthesiol. 2025 Apr 5;25(1):155. doi: 10.1186/s12871-025-03017-x.
- Background: PubMed 40328198Yu X, Liu C. Intertransverse process block: A narrative review. J Clin Anesth. 2025 Jun;104:111857. doi: 10.1016/j.jclinane.2025.111857. Epub 2025 May 5.
- Background: PubMed 37607803Varela V, Ruiz C, Montecinos S, Prats-Galino A, Sala-Blanch X. Spread of local anesthetic injected in the paravertebral space, intertransverse processes space, and erector spinae plane: a cadaveric model. Reg Anesth Pain Med. 2024 Mar 4;49(3):228-232. doi: 10.1136/rapm-2023-104342.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in publications will be shared upon reasonable request to the principal investigator, after approval of a methodologically sound proposal and signing of a data access agreement.
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ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
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. This study is not recruiting at the moment.
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 study testing Erector Spinae Plane Block, Intertransverse Process Block and Local anesthetic infiltration in people with Postoperative Pain Control and Lumbar Spine Surgery, run by Hanoi Medical University at 1 site in Vietnam.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 16 Oct 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 Vietnam. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cumulative Morphine Consumption Within 24 Hours After Surgery (time frame: From Hour 0 (awake in the recovery room) to Hour 24 after surgery). 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 NCT07878013, which also lists 5 linked publications.
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 16 Oct 2026.