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Serratus Anterior Plane Block to Prevent Chronic Postoperative Pain in Breast Cancer (USB22)

Primary Purpose

Breast Neoplasms, Pain, Postoperative, Pain, Chronic

Status
Recruiting
Phase
Not Applicable
Locations
Morocco
Study Type
Interventional
Intervention
Serratus Anterior Plane Block with local anesthetic
Serratus Anterior Plane Block with saline solution
Sponsored by
Moroccan Society of Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Neoplasms

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Having an age greater than or equal to 18 years and less than 70 years
  • Having given written consent for participation in the study and the use of personal and medical data
  • Having a physical status of class I, II or III of the American Society of Anesthesiologists

Exclusion Criteria:

  • Patients who expressed their refusal to participate in the study
  • Patients unable to express their non-objection to participation in the study
  • American Society of Anesthesiologists class > III patients
  • Known allergy to local anesthetics
  • A contraindication to performing a peripheral nerve block (such as an acquired, constitutional or drug clotting disorder or infection at the nerve block injection site)
  • Morbid obesity (body mass index greater than 40 kg/m²)
  • Chronic use of opioids
  • Inability to use the patient controlled analgesia device
  • The existence of preoperative pain
  • History of neuropathy or neurological pathology
  • The existence of catastrophism or anxiety diagnosed preoperatively

Sites / Locations

  • Anesthesia & Critical care department - National Institut of Oncology in Rabat. Ibn Sina teaching Hospital. Mohammed V university of RabatRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Placebo

Serratus anterior plane block

Arm Description

Outcomes

Primary Outcome Measures

Chronic postoperative pain at 3 months
A question will be asked to patients : "Throughout our lives, most have had pain (like headaches, sprains and toothaches). Have you had pain other than these types of pain on a daily basis since your surgery? " The answer "yes" or "no" will determine the outcome
chronic postoperative pain intensity
Pain intensity of patients was evaluated by Numerical Rating Scale, rating from 0 (no pain) to 10 (extreme pain) in order to evaluate the effect of Serratus Anterior Plane Block in preventing chronic pain

Secondary Outcome Measures

Chronic Pain intensity and quality
Pain intensity of patients was evaluated by Arabic version of Brief pain inventory
Neuropathic pain screening
Neuropathic pain will be screened by "Douleur Neuropathique 4" score
Morphine consumption
Morphine rescue dose for extra need of analgesic

Full Information

First Posted
August 6, 2022
Last Updated
September 19, 2022
Sponsor
Moroccan Society of Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT05494281
Brief Title
Serratus Anterior Plane Block to Prevent Chronic Postoperative Pain in Breast Cancer
Acronym
USB22
Official Title
Serratus Anterior Plane Block to Prevent Chronic Pain in Breast Cancer Surgery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Moroccan Society of Surgery

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Chronic postoperative pain (CPP) remains a disturbing and obscure clinical problem. The hypothesis of this trial is that a peripheral block of the serratus anterior plane block type preoperatively after a modified radical mastectomy makes it possible to reduce the intensity and incidence of chronic post-surgical pain in breast cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Pain, Postoperative, Pain, Chronic, Post-Mastectomy Chronic Pain Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Experimental
Arm Title
Serratus anterior plane block
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Serratus Anterior Plane Block with local anesthetic
Intervention Description
A deep analgesic block of the Serratus anterior plane block (SAPB) type by echo-guided lateral approach will be performed by An 8-13 Mhz high frequency linear ultrasound probe witch will be located cranio-caudally, transversely to the 3rd and 4th intercostal space on the mid-axillary line while patients are supine with the ipsilateral upper limb raised to 90°. Once the landmark anatomical structures have been identified (upper rib, lower rib, pleural line, Serratus muscle, superficial structures), the puncture will begin Under aseptic conditions, an 80 mm 22 gauge needle will be inserted into the "in-plane" view of the ultrasound probe. When the needle has reached the plane under Serratus between the Serratus muscle and the intercostal muscle opposite the lower edge of the upper rib, 30 ml of 1% Lidocaine will be administered.
Intervention Type
Procedure
Intervention Name(s)
Serratus Anterior Plane Block with saline solution
Intervention Description
A deep analgesic block of the Serratus anterior plane block (SAPB) type by echo-guided lateral approach will be performed by An 8-13 Mhz high frequency linear ultrasound probe witch will be located cranio-caudally, transversely to the 3rd and 4th intercostal space on the mid-axillary line while patients are supine with the ipsilateral upper limb raised to 90°. Once the landmark anatomical structures have been identified (upper rib, lower rib, pleural line, Serratus muscle, superficial structures), the puncture will begin Under aseptic conditions, an 80 mm 22 gauge needle will be inserted into the "in-plane" view of the ultrasound probe. When the needle has reached the plane under Serratus between the Serratus muscle and the intercostal muscle opposite the lower edge of the upper rib, 30 ml of saline solution
Primary Outcome Measure Information:
Title
Chronic postoperative pain at 3 months
Description
A question will be asked to patients : "Throughout our lives, most have had pain (like headaches, sprains and toothaches). Have you had pain other than these types of pain on a daily basis since your surgery? " The answer "yes" or "no" will determine the outcome
Time Frame
3 months after surgery
Title
chronic postoperative pain intensity
Description
Pain intensity of patients was evaluated by Numerical Rating Scale, rating from 0 (no pain) to 10 (extreme pain) in order to evaluate the effect of Serratus Anterior Plane Block in preventing chronic pain
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
Chronic Pain intensity and quality
Description
Pain intensity of patients was evaluated by Arabic version of Brief pain inventory
Time Frame
3 months after surgery
Title
Neuropathic pain screening
Description
Neuropathic pain will be screened by "Douleur Neuropathique 4" score
Time Frame
3 months after surgery
Title
Morphine consumption
Description
Morphine rescue dose for extra need of analgesic
Time Frame
0-24 hours after operation

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women Having to undergo an elective unilateral modified total mastectomy with dissection of the axillary lymph nodes (modified Patey procedure) for curative purposes for oncological pathology of the breast, performed in the operating room of the Gyneco-mammary center of INO, without breast reconstruction
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having an age greater than or equal to 18 years and less than 70 years Having given written consent for participation in the study and the use of personal and medical data Having a physical status of class I, II or III of the American Society of Anesthesiologists Exclusion Criteria: Patients who expressed their refusal to participate in the study Patients unable to express their non-objection to participation in the study American Society of Anesthesiologists class > III patients Known allergy to local anesthetics A contraindication to performing a peripheral nerve block (such as an acquired, constitutional or drug clotting disorder or infection at the nerve block injection site) Morbid obesity (body mass index greater than 40 kg/m²) Chronic use of opioids Inability to use the patient controlled analgesia device The existence of preoperative pain History of neuropathy or neurological pathology The existence of catastrophism or anxiety diagnosed preoperatively
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdelilah GHANNAM, MD
Phone
+212661382585
Email
a.ghannam@um5r.ac.ma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdelilah GHANNAM, MD
Organizational Affiliation
Mohammed V University in Rabat
Official's Role
Study Director
Facility Information:
Facility Name
Anesthesia & Critical care department - National Institut of Oncology in Rabat. Ibn Sina teaching Hospital. Mohammed V university of Rabat
City
Rabat
ZIP/Postal Code
10100
Country
Morocco
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdelilah GHANNAM, MD
Phone
+212661382585
Email
a.ghannam@um5r.ac.ma

12. IPD Sharing Statement

Plan to Share IPD
No

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Serratus Anterior Plane Block to Prevent Chronic Postoperative Pain in Breast Cancer

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