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Continuous Nerve Block Block vs Combination of Single Block Plus Intravenous Lidocaine for Postoperative Pain.
Phase 4 trial testing Continuous Erector Spinae Plane Nerve Block in Postoperative Pain in 17 participants. Terminated before completion.
| Lead sponsor | Jeremy Kearns |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 17 |
| Start date | 26 May 2021 |
| Primary completion | 18 August 2022 |
| Estimated completion | 18 August 2022 |
| Sites | 1 location across United States |
Jeremy Kearns
Adults 18 to 90, any sex, with Postoperative Pain. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Opioids will be converted to oral morphine equivalents
| Group | Value | 95% CI |
|---|---|---|
| Continuous Nerve Blocks | 34.93 | ± 31.32 |
| Single Nerve Blocks Plus IV Lidocaine Infusion | 46.50 | ± 33.37 |
Opioids will be converted to oral morphine equivalents
| Group | Value | 95% CI |
|---|---|---|
| Continuous Nerve Blocks | 61.5 | ± 54.06 |
| Single Nerve Blocks Plus IV Lidocaine Infusion | 84.75 | ± 65.57 |
Opioids will be converted to oral morphine equivalents
| Group | Value | 95% CI |
|---|---|---|
| Continuous Nerve Blocks | 88.57 | ± 60.24 |
| Single Nerve Blocks Plus IV Lidocaine Infusion | 128.1 | ± 150.29 |
By numeric pain rating scale, 0 = no pain and 10 = worst possible pain
| Group | Value | 95% CI |
|---|---|---|
| Continuous Nerve Blocks | 6.17 | ± 3.25 |
| Single Nerve Blocks Plus IV Lidocaine Infusion | 6.14 | ± 1.77 |
By numeric pain rating scale, 0 = no pain and 10 = worst possible pain
| Group | Value | 95% CI |
|---|---|---|
| Continuous Nerve Blocks | 6.17 | ± 3.67 |
| Single Nerve Blocks Plus IV Lidocaine Infusion | 6.07 | ± 2.83 |
By numeric pain rating scale, 0 = no pain and 10 = worst possible pain
| Group | Value | 95% CI |
|---|---|---|
| Continuous Nerve Blocks | 4.5 | ± 2.17 |
| Single Nerve Blocks Plus IV Lidocaine Infusion | 6.43 | ± 2.88 |
By numeric pain rating scale, 0 = no pain and 10 = worst possible pain
| Group | Value | 95% CI |
|---|---|---|
| Continuous Nerve Blocks | 5.86 | ± 2.67 |
| Single Nerve Blocks Plus IV Lidocaine Infusion | 4.83 | ± 3.37 |
By numeric pain rating scale, 0 = no pain and 10 = worst possible pain
| Group | Value | 95% CI |
|---|---|---|
| Continuous Nerve Blocks | 5.36 | ± 1.75 |
| Single Nerve Blocks Plus IV Lidocaine Infusion | 5.0 | ± 1.83 |
Local anesthetic consumption after surgery is reported in mg of lidocaine
| Group | Value | 95% CI |
|---|---|---|
| Continuous Nerve Blocks | 574.29 | ± 179.73 |
| Single Nerve Blocks Plus IV Lidocaine Infusion | 600 | ± 0 |
Local anesthetic consumption after surgery is reported in mg of lidocaine
| Group | Value | 95% CI |
|---|---|---|
| Continuous Nerve Blocks | 1096.07 | ± 330.01 |
| Single Nerve Blocks Plus IV Lidocaine Infusion | 1139.29 | ± 160.63 |
Local anesthetic consumption after surgery is reported in mg of lidocaine
| Group | Value | 95% CI |
|---|---|---|
| Continuous Nerve Blocks | 1973.57 | ± 717.70 |
| Single Nerve Blocks Plus IV Lidocaine Infusion | 2308.33 | ± 149.72 |
Local anesthetic consumption after surgery is reported in mg of lidocaine
| Group | Value | 95% CI |
|---|---|---|
| Continuous Nerve Blocks | 2721.79 | ± 896.91 |
| Single Nerve Blocks Plus IV Lidocaine Infusion | 2570.0 | ± 499.50 |
Time frame: Adverse event data was collected from hospital admission until hospital discharge. In this sample the timeline ranged from 1 day to 13 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Continuous Nerve Blocks | Single Nerve Blocks Plus I… |
|---|---|---|---|
| Abnormal Lidocaine Blood Level | Product Issues | — | — |
| Reaction | System | Continuous Nerve Blocks | Single Nerve Blocks Plus I… |
|---|---|---|---|
| Lethargy | Nervous system disorders | — | — |
Most-reported serious reactions: Abnormal Lidocaine Blood Level.
Data from ClinicalTrials.gov NCT04208516 adverse events section.
A multimodal analgesic regimen including regional anesthesia is used at UPMC Shadyside for primary thoracic and major abdominal surgeries. The current standard-of-care regional anesthesia techniques include Erector Spinae Plane (ESP) block for video assisted thorascopic surgery (VATS) and Quadratus Lumborum (QL) block for major abdominal surgery. These blocks are routinely administered as a continuous catheter technique in order to extend the duration of postoperative analgesia. Although rare, continuous nerve block techniques carry risks and limitations, including catheter dislodgement, migration, kinking and leaking at the site, bleeding, and infection. They are also much more expensive to perform and maintain than single-injection nerve blocks at this institution. Perioperative intravenous (IV) lidocaine is one of the safest local anesthetics, and its use has been shown to provide analgesia and reduce opioid requirements. Furthermore, it has been hypothesized that part of the analgesic efficacy of continuous peripheral nerve blocks may be due to the systemic effects of the local anesthetic infused at the site. Therefore, it is possible that the combination of a single block followed by an infusion of IV lidocaine may provide the same benefits as a continuous nerve block at a lower cost. The purpose of this study is to show that a single block technique plus IV lidocaine is non-inferior to a continuous block technique. For the purpose of this study we chose two surgical models--VATS and major abdominal surgery--and ESP and QL blocks, respectively. The study will be conducted as a prospective, randomized (1:1), open-label, active-comparator, noninferiority trial. The study will prospectively investigate the efficacy of continuous block versus single block plus IV lidocaine infusion for postoperative pain management in patients undergoing primary unilateral VATS or primary major abdominal surgery.
No peer-reviewed publications indexed yet for this trial.
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