The Analgesic Efficacy of the Pectoral Nerves Block Versus Local Anesthetic Infiltration After Mastectomy

NCT ID: NCT04116021

Last Updated: 2019-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2021-06-30

Brief Summary

This trial will include patients undergoing radical mastectomy under general anesthesia. One group of patients will receive a pectoral nerve block, done by the anesthetist under ultrasound guidance at the beginning of the invervention. The other group will receive the a wound infiltration at the end of the intervention, done by the surgeon. Investigators will compare acute pain-related outcomes and chronic pain at 3 and 6 months postoperatively.

Detailed Description

Mastectomies are associated with moderate to severe postoperative pain. In addition to general anesthesia, different methods of locoregional anesthesia exist to treat postoperative pain, amongst others a pectoral nerve block. This block consists in injecting local anesthetic between the muscles of the thoracic wall and is done under ultrasound guidance. Over the last few years, the pectoral nerves block has become a recognized option for the treatment of acute post-mastectomy pain and it is routinely performed in addition to general anesthesia.

Data indicates that pectoral nerve blocks are effective for the treatment of postoperative pain during the first 24 hours after mastectomy, when compared to no block. However, the analgesic efficacy of a pectoral nerve block has never systematically compared to that of wound infiltration with local anesthetics, done by the surgeon at the end of the intervention. Such an infiltration is also currently employed.

In our study randomize patients undergoing mastectomy under general anesthesia will be randomized to receive either an ultrasound-guided pectoral nerve block with 30 mL of local anesthetic (group PECS) or a wound infiltration with 30 mL of local anesthetic (group infiltration).

Investigators will assess different pain-related outcomes over the first 24 postoperative hours, together with potential block-related side effects and patient satisfaction. Chronic postoperative pain at 3 and 6 months postoperatively will also be assessed.

Both patients and outcome assessors will be blinded to group allocation.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

PECS block

Ultrasound-guided pectoral nerve block with bupivacaine 0.5 % 30 mL before surgical incision

Group Type: ACTIVE_COMPARATOR

PECS block

Intervention Type: OTHER

Ultrasound-guided PECS block before surgical incision with 30 mL bupivacaine 0.5 %

Wound infiltration

Wound infiltration with bupivacaine 0.5 % 30 mL at the end of surgery

Group Type: ACTIVE_COMPARATOR

Local infiltration

Intervention Type: OTHER

Wound infiltration at the end of surgery with with 30 mL bupivacaine 0.5 %

Interventions

PECS block

Ultrasound-guided PECS block before surgical incision with 30 mL bupivacaine 0.5 %

Intervention Type: OTHER

Local infiltration

Wound infiltration at the end of surgery with with 30 mL bupivacaine 0.5 %

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients undergoing unilateral mastectomy
• American Society of Anesthesiology Physical Status I-III
• Age ≥ 18

Exclusion Criteria

• Contraindications to regional anesthesia, such as infection at the surgical site
• Pregnancy
• History of alcohol or drug dependence/abuse
• History of long term opioid intake
• Chronic pain disorder

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Lausanne Hospitals

OTHER

Sponsor Role: collaborator

Hôpital du Valais

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sina Grape

Role: PRINCIPAL_INVESTIGATOR

Hopital du Valais

Central Contacts

Sina Grape, MD

Role: CONTACT

sina.grape@hopitalvs.ch

0041276038759

Eric Albrecht, MD

Role: CONTACT

eric.albrecht@chuv.ch

0041763281145

Other Identifiers

PECS 2019

Identifier Type: -

Identifier Source: org_study_id