The Analgesic Efficacy of the Pectoral Nerves Block Versu... | NCT04116021

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

NCT04116021

Sponsor

Hôpital du Valais

Status

Unknown status

Last Update Posted

Oct 4, 2019Actual

Enrollment

50Estimated

Phase

Phase 4

Conditions

Breast Cancer

Interventions

PECS block
Local infiltration

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2019Estimated

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Jun 30, 2021Estimated

First Submitted Date

Oct 2, 2019

First Submission Date that Met QC Criteria

Oct 3, 2019

First Posted Date

Oct 4, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2019

Last Update Posted Date

Oct 4, 2019Actual

Name	Class
University of Lausanne Hospitals	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PECS block	Active Comparator	Ultrasound-guided pectoral nerve block with bupivacaine 0.5 % 30 mL before surgical incision	Other: PECS block
Wound infiltration	Active Comparator	Wound infiltration with bupivacaine 0.5 % 30 mL at the end of surgery	Other: Local infiltration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PECS block	Other	Ultrasound-guided PECS block before surgical incision with 30 mL bupivacaine 0.5 %	PECS block

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sina Grape, MD	Contact	0041276038759		sina.grape@hopitalvs.ch
Eric Albrecht, MD	Contact	0041763281145		eric.albrecht@chuv.ch

Overall Officials

Name	Affiliation	Role
Sina Grape	Hopital du Valais	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000772	Anesthesia, Local

Ancestor Terms

ID	Term
D000765	Anesthesia, Conduction
D000758	Anesthesia
D000760	Anesthesia and Analgesia

Browse Leaves

Not provided

Browse Branches

Not provided