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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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
What is being tested?
Erector Spinae Plane Block, Intertransverse Process Block and Local anesthetic infiltration
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

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.

Vietnam1 site
  • Hanoi Medical University

    Hanoi, 100000

Other trials in Vietnam

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 groups in NCT07878013
Study groupRoleWhat they receive
Erector Spinae Plane Block (ESPB)ExperimentalBilateral 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)ExperimentalBilateral 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 comparatorNo 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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.

  1. First posted16 Oct 2026
  2. Study start1 Mar 2026
  3. Primary completion31 Aug 2026
  4. Study completion31 Aug 2026

Resources

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)
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 42449236
  • Qian 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 39474710
  • Wang 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 40188337
  • Yu 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 40328198
  • Varela 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

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