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

The Analgesic Efficacy of the Pectoral Nerves Block Versus Local Anesthetic Infiltration After Mastectomy: a Randomized, Controlled, Double Blinded Trial

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Other: PECS block; Other: Local infiltration

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sina Grape, MD; Phone Number: 0041276038759; Email: sina.grape@hopitalvs.ch
• Study Contact Backup: Name: Eric Albrecht, MD; Phone Number: 0041763281145; Email: eric.albrecht@chuv.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PECS block; Ultrasound-guided pectoral nerve block with bupivacaine 0.5 % 30 mL before surgical incision	Other: PECS block; Ultrasound-guided PECS block before surgical incision with 30 mL bupivacaine 0.5 %
Active Comparator: Wound infiltration; Wound infiltration with bupivacaine 0.5 % 30 mL at the end of surgery	Other: Local infiltration; Wound infiltration at the end of surgery with with 30 mL bupivacaine 0.5 %

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine consumption	Cumulative intravenous morphine consumption (mg)	first 24 postoperative hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hôpital du Valais
• Collaborators: University of Lausanne Hospitals
• Investigators: Principal Investigator: Sina Grape, Hopital du Valais

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: October 2, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 4, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2019
• Last Update Submitted That Met QC Criteria: October 3, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: mastectomy
• Other Study ID Numbers: PECS 2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No