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PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery
Phase 2 trial testing Bupivacaine in Breast Cancer in 134 participants. Completed in 25 February 2021.
| Lead sponsor | Washington University School of Medicine |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 134 |
| Start date | 7 June 2017 |
| Primary completion | 25 February 2021 |
| Estimated completion | 25 February 2021 |
| Sites | 1 location across United States |
Washington University School of Medicine
18 and older, female only, with Breast Cancer or Breast Cancer Female. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
* The participant is asked to rate their pain by circling the one number that best describes their pain at its worst in the past week. * 0=no pain and 10 = pain as bad as they can imagine. The higher number indicates worse pain.
| Group | Value | 95% CI |
|---|---|---|
| Preoperative PECS Blocks | 0 | 0 – 1 |
| Placebo PECS Blocks | 0 | 0 – 0.8 |
* The participant is asked to rate their pain by circling the one number that best describes their pain on the average. * 0=no pain and 10 = pain as bad as they can imagine. The higher number indicates worse pain.
| Group | Value | 95% CI |
|---|---|---|
| Preoperative PECS Blocks | 0 | 0 – 0.2 |
| Placebo PECS Blocks | 0 | 0 – 0.2 |
* The participant is asked circle the one number that describes how much, during the past week pain has interfered with general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, sleep, and enjoyment of life. * 0=does not interference and 10 = completely interferes. The higher number indicates more interference from pain. * The scores for each subsection will be averaged.
| Group | Value | 95% CI |
|---|---|---|
| Preoperative PECS Blocks | 0 | 0 – 0 |
| Placebo PECS Blocks | 0 | 0 – 0 |
* The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The 12 items are summarized into two scores, a Physical Health Summary Measure (PCS) and a Mental Health Summary Measure (MCS). * The higher the score the better quality of life. * Scores are standardized to a mean of 50 with a range of -0.809-70.71.
| Group | Value | 95% CI |
|---|---|---|
| Preoperative PECS Blocks | -3.1 | -18.0 – 1.9 |
| Placebo PECS Blocks | -0.8 | -10.3 – 7.8 |
* The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The 12 items are summarized into two scores, a Physical Health Summary Measure (PCS) and a Mental Health Summary Measure (MCS). * The higher the score the better quality of life. * Scores are standardized to a mean of 50 with a range of -1.465-77.09.
| Group | Value | 95% CI |
|---|---|---|
| Preoperative PECS Blocks | 0 | -5.5 – 7.6 |
| Placebo PECS Blocks | 1.9 | -5.8 – 11.3 |
Time frame: -Adverse events will be tracked for 2 weeks after nerve block administration or patient discharge, whichever is later, up to 3 weeks. Most patients will be discharged within 24 hours. Adverse events thought to be at least possibly related to surgery will not be collected. -All-cause mortality was collected from day of surgery through completion of follow-up, up to 1 year. The one mortality occurred during follow-up and attribution to the PECS block was deemed as unrelated.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Preoperative PECS Blocks | Placebo PECS Blocks | Not Randomized to an Arm |
|---|---|---|---|---|
| Hematoma | Vascular disorders | — | — | — |
| Seroma | Injury, poisoning and procedural complications | — | — | — |
| Swelling | General disorders | — | — | — |
Data from ClinicalTrials.gov NCT03084536 adverse events section.
In this double blinded randomized placebo-controlled trial, 160 subjects scheduled for breast surgery involving the axilla will be administered a multimodal pain regimen including acetaminophen, dexamethasone, celecoxib, and gabapentin. 80 subjects will also receive a Pectoral Nerve blocks I and II (PECS I and II block) preoperatively.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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