Postoperative Pain Control, Lumbar Spine Surgery, Degenerative Lumbar Spine Diseases
Conditions
Keywords
Erector Spinae Plane Block, Intertransverse Process Block, Ultrasound-Guided Regional Anesthesia, Paraspinal Block, Opioid Consumption, Patient-Controlled Analgesia, Multimodal Analgesia
Brief 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. 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.
Interventions
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.
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.
Subcutaneous infiltration along both sides of the planned skin incision by the surgeon after induction of general anesthesia and before skin incision.
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.
Sponsors
Study design
Masking description
No masking was used. Because of the nature of the interventions, the anesthesiologists performing the blocks could not be blinded. Patients in the block groups received the block while awake before induction of anesthesia, whereas patients in the control group received local infiltration after induction, so participants could not be reliably blinded to group allocation. The investigators who performed the blocks also assessed the outcomes. To limit bias, the anesthesia protocol, criteria for intraoperative fentanyl supplementation, and postoperative PCA settings were standardized across all groups.
Intervention 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).
Eligibility
Inclusion criteria
* 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.
Exclusion criteria
* \- 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Morphine Consumption Within 24 Hours After Surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Morphine Consumption Within 12 Hours After Surgery | From Hour 0 (awake in the recovery room) to Hour 12 after surgery | Total amount of intravenous morphine (mg) delivered by the PCA pump, including any supplemental morphine, from Hour 0 to Hour 12. |
| Pain Score at Rest | Hour 0 (awake in the recovery room), and Hours 1, 2, 4, 8, 12 and 24 after surgery | 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. |
| Pain Score on Movement | Hour 0 (awake in the recovery room), and Hours 1, 2, 4, 8, 12 and 24 after surgery | 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. |
| Total Intraoperative Fentanyl Consumption | From induction of anesthesia to the end of surgery | 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. |
| Intraoperative Heart Rate | 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. | Heart rate (beats/min) |
| Intraoperative Mean Arterial Pressure | 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 | Mean arterial pressure (mmHg) |
| Postoperative Heart Rate | Hour 0 (awake in the recovery room), and Hours 1, 2, 4, 8, 12 and 24 after surgery | Heart rate (beats/min) |
| Postoperative Mean Arterial Pressure | Hour 0 (awake in the recovery room), and Hours 1, 2, 4, 8, 12 and 24 after surgery | Mean arterial pressure (mmHg) |
| Postoperative Respiratory Rate | Hour 0 (awake in the recovery room), and Hours 1, 2, 4, 8, 12 and 24 after surgery | Respiratory rate (breaths/min) |
| Postoperative Peripheral Oxygen Saturation | Hour 0 (awake in the recovery room), and Hours 1, 2, 4, 8, 12 and 24 after surgery | Peripheral oxygen saturation (%) measured by pulse oximetry |
| Time to First Analgesic Request | From Hour 0 (awake in the recovery room) up to Hour 24 after surgery | 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. |
Countries
Vietnam