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

Phase 4

• Conditions: Breast Cancer
• Interventions: Other: PECS block; Other: Local infiltration

• Registration Number: NCT04116021
• Lead Sponsor: Hôpital du Valais

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.

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-02
• Study First Submitted QC: 2019-10-03
• Last Update Submitted: 2019-10-03
• Study First Posted: 2019-10-04
• Last Update Posted: 2019-10-04
• Study Start: 2019-11-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PECS block	PECS block	Ultrasound-guided pectoral nerve block with bupivacaine 0.5 % 30 mL before surgical incision
Wound infiltration	Local infiltration	Wound infiltration with bupivacaine 0.5 % 30 mL at the end of surgery

Primary Outcome Measures

Name	Time	Method
Morphine consumption	first 24 postoperative hours	Cumulative intravenous morphine consumption (mg)

Secondary Outcome Measures

Name	Time	Method
Pain score at rest at 2 hours postoperatively	2 hours postoperatively	Numeric rating scale from 0 = no pain to 10 = worst imaginable pain
Pain score at rest at 12 hours postoperatively	12 hours postoperatively	Numeric rating scale from 0 = no pain to 10 = worst imaginable pain
Pain score at rest at 24 hours postoperatively	24 hours postoperatively	Numeric rating scale from 0 = no pain to 10 = worst imaginable pain
Pain score on movement at 2 hours postoperatively	2 hours postoperatively	Numeric rating scale from 0 = no pain to 10 = worst imaginable pain
Pain score on movement at 12 hours postoperatively	12 hours postoperatively	Numeric rating scale from 0 = no pain to 10 = worst imaginable pain
Pain score on movement at 24 hours postoperatively	24 hours postoperatively	Numeric rating scale from 0 = no pain to 10 = worst imaginable pain
Time to first analgesic request	24 hours postoperatively	Time between end of surgery and first analgesic request by patient, in minutes