APECS II: Comparing the efficacy of Pectoral Nerve (PECS II) Block with long-acting liposomal bupivacaine versus levobupivacaine for Mastectomy Surgery: A Multicenter Prospective Randomized Controlled Trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

St. Antonius Ziekenhuis

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03], Diseases [C] - Neoplasms [C04]

Decision date (initial)

2024-06-18

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-515183-30-00

EudraCT number

2022-004128-16

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To assess whether postoperative NRS pain scores in the breast after mastectomy is lower in patients who receive a preoperative PECS II block with liposomal bupivacaine than in patients who receive a preoperative PECS II block with levobupivacaine.

Secondary objectives 8

1. To assess whether perioperative opioid use is lower after mastectomy in patients who receive a preoperative PECS II block with liposomal bupivacaine than in patients who receive a preoperative PECS II block with levobupivacaine.
2. To assess whether postoperative NRS pain scores in the axilla after mastectomy in patients who receive a preoperative PECS II block with liposomal bupivacaine than in patients who receive a preoperative PECS II block with levobupivacaine.
3. To assess whether the postoperative need other pain killers after mastectomy in patients who receive a preoperative PECS II block with liposomal bupivacaine than in patients who receive a preoperative PECS II block with levobupivacaine.
4. To assess whether patients have less chronic pain (> 12 weeks) after mastectomy in patients who receive a preoperative PECS II block with liposomal bupivacaine than in patients who receive a preoperative PECS II block with levobupivacaine.
5. To assess whether patients are more satisfied after mastectomy in patients who receive a preoperative PECS II block with liposomal bupivacaine than in patients who receive a preoperative PECS II block with levobupivacaine, measured by the BREAST-Q BCT.
6. To assess whether the postoperative time that patients need to be observed in the recovery room after mastectomy is shorter in patients who receive a preoperative PECS II block with liposomal bupivacaine than in patients who receive a preoperative PECS II block with levobupivacaine.
7. To assess whether the time until discharge from the hospital after mastectomy in patients who receive a preoperative PECS II block with liposomal bupivacaine than in patients who receive a preoperative PECS II block with levobupivacaine.
8. To assess whether patients after mastectomy who receive a preoperative PECS II block with liposomal bupivacaine experience less postoperative nausea and vomiting (PONV) than patients who receive a preoperative PECS II block with levobupivacaine.

Conditions and MedDRA coding

Postoperative and chronic pain after breast cancer surgery

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Unilateral mastectomy.
2. Written informed consent according to ICH/GCP and national regulations.
3. ASA (American Society of Anesthesiologists) Class I-III.

Exclusion criteria 15

1. Patients < 18 year old.
2. Bilateral surgery.
3. Bleeding disorder or coagulopathy.
4. Chest wall deformity or infection of injection site.
5. Another (additional) nerve block (such as TPVB or epidural anesthesia).
6. Autologous or implant based breast reconstruction.
7. Known allergy for (levo)bupivacaine or local anesthetics from the amide group.
8. Known allergy or contra-indication for NSAID.
9. Chronic use of opiates preoperatively (> 12 weeks).
10. Previous breast surgery ipsi- or contralateral (except diagnostic biopsies).
11. Not able to speak or understand the Dutch language fluently.
12. Palliative surgery.
13. Metastatic disease.
14. Pregnancy or breast feeding.
15. Psychological, neurological, familial, sociological or geographical factors that could potentially hamper compliance with the study protocol

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Postoperative NRS pain scores in the breast.

Secondary endpoints 10

1. Postoperative NRS pain scores in the axilla.
2. Intraoperative need of opiates (milligrams).
3. Postoperative need of opiates or other pain killers (milligrams).
4. Patient-reported chronic (> 12 weeks) pain (yes/no).
5. Patient satisfaction, measured by the BREAST-Q BCT.
6. Postoperative time that patients need to be observed in the recovery room (minutes).
7. Time until patients are discharged from the hospital (hours).
8. Use of additional anti-emetics for PONV (yes/no).
9. Vomiting (yes/no).
10. Complications (wound infection rate, hematoma, abscess, pneumothorax, local anesthesia systemic toxicity).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

St. Antonius Ziekenhuis

Sponsor organisation

St. Antonius Ziekenhuis

Address

Koekoekslaan 1

City

Nieuwegein

Postcode

3435 CM

Country

Netherlands

Scientific contact point

Organisation

St. Antonius Ziekenhuis

Contact name

PhD candidate

Public contact point

Organisation

St. Antonius Ziekenhuis

Contact name

PhD candidate

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Application history

1 submissions — initial application plus substantial / non-substantial modifications