Efficacy of Pectoral Nerve (PECS II) Block for Breast Conserving Surgery: A Prospective Randomized Controlled Trial

Efficacy of Pectoral Nerve (PECS II) Block for Breast Conserving Surgery: A Prospective Randomized Controlled Trial - CONPECSII

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50121

Enrollment

200

Registered

2020-01-20

Start date

2020-06-15

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breastcancer mammacarcinoma

Interventions

One arm receives a pre-operative PECS II block prior to breast-conserving surgery and the second arm receives a sham block with NaCl for BCS.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Female gender. - Unilateral breast conserving surgery. - Written informed consent according to ICH/GCP and national regulations. - ASA (American Society of Anesthesiologists) Class I-III .

Exclusion criteria

Exclusion criteria: - Women above 18 year old. - Bilateral surgery. - Bleeding disorder or coagulopathy. - Chest wall deformity or infection of injection site. - Another (additional) nerve block (such as TPVB or epidural anesthesia). - Oncoplastic breast conserving surgery. - Autologous or implant based breast reconstruction. - Known allergy for levobupivacaine or local anesthetics from the amide group. - Chronic use of analgesics / opiates preoperatively (> 12 weeks). - Previous breast surgery ipsi- or contralateral (except diagnostic biopsies). - Not able to speak or understand the Dutch language fluently. - Palliative surgery. - Metastatic disease. - Pregnancy or breast feeding. - Psychological, neurological, familial, sociological or geographical factors that could potentially hamper compliance with the study protocol. - Other concurrent solid tumor.

Design outcomes

Primary

Measure	Time frame
To assess whether postoperative NRS pain scores in the breast after BCS is lower in women who receive a preoperative PECS II block than in women who receive a sham block.	—

Secondary

Measure	Time frame
- To assess whether postoperative NRS pain scores in the axilla after BCS is lower in women who receive a preoperative PECS II block than in women who receive a sham block. - To assess whether the intraoperative need of opiates in women who undergo BCS is lower in women who receive a preoperative PECS II block than in women who receive a sham block. - To assess whether the postoperative need of opiates or other pain killers after BCS is lower in women who receive a preoperative PECS II block than in women who receive a sham block. - To assess whether women have less chronic pain (> 12 weeks) from BCS after receiving a preoperative PECS II block than women who receive a sham block. - To assess whether women are more satisfied after receiving a preoperative PECS II block than women who receive a sham block, measured by the BREAST-Q BCT. - To assess whether the postoperative time that women need to be observed in the recovery room after BCS is shorter in women who receive a preoperative PECS II block than in women who receive a sham block. - To assess whether the time until discharge from the hospital after BCS is shorter in women who receive a preoperative PECS II block than in women who receive a sham block. - To assess whether women experience less postoperative nausea and vomiting (PONV) after BCS when receiving a preoperative PECS II block compared to those who receive a sham block. - To assess the difference in operating time in women who undergo BCS is no longer in women who receive a preoperative PECS II block than in a random sample of women who did not receive a PECS II block. - To assess whether women who undergo BCS with a preoperative PECS II block do not have more wound infections or other complications than women in a random sample who did not receive a PECS II block before their breast conserving surgery.	—

Measure

Time frame

- To assess whether postoperative NRS pain scores in the axilla after BCS is lower in women who receive a preoperative PECS II block than in women who receive a sham block. - To assess whether the intraoperative need of opiates in women who undergo BCS is lower in women who receive a preoperative PECS II block than in women who receive a sham block. - To assess whether the postoperative need of opiates or other pain killers after BCS is lower in women who receive a preoperative PECS II block than in women who receive a sham block. - To assess whether women have less chronic pain (> 12 weeks) from BCS after receiving a preoperative PECS II block than women who receive a sham block. - To assess whether women are more satisfied after receiving a preoperative PECS II block than women who receive a sham block, measured by the BREAST-Q BCT. - To assess whether the postoperative time that women need to be observed in the recovery room after BCS is shorter in women who receive a preoperative PECS II block than in women who receive a sham block. - To assess whether the time until discharge from the hospital after BCS is shorter in women who receive a preoperative PECS II block than in women who receive a sham block. - To assess whether women experience less postoperative nausea and vomiting (PONV) after BCS when receiving a preoperative PECS II block compared to those who receive a sham block. - To assess the difference in operating time in women who undergo BCS is no longer in women who receive a preoperative PECS II block than in a random sample of women who did not receive a PECS II block. - To assess whether women who undergo BCS with a preoperative PECS II block do not have more wound infections or other complications than women in a random sample who did not receive a PECS II block before their breast conserving surgery.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)