USB22: Serratus Anterior Plane Block to Prevent Chronic Postoperative Pan in Breast Cancer

Sponsor
Moroccan Society of Surgery (Other)
Overall Status
Recruiting
CT.gov ID
NCT05494281
Collaborator
(none)
94
1
2
12
7.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Serratus Anterior Plane Block with local anesthetic
  • Procedure: Serratus Anterior Plane Block with saline solution
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
94 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Serratus Anterior Plane Block to Prevent Chronic Pain in Breast Cancer Surgery: A Randomized Controlled Trial
Actual Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Placebo

Procedure: Serratus Anterior Plane Block with saline solution
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

Experimental: Serratus anterior plane block

Procedure: Serratus Anterior Plane Block with local anesthetic
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.

Outcome Measures

Primary Outcome Measures

  1. Chronic postoperative pain at 3 months [3 months after surgery]

    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

  2. chronic postoperative pain intensity [3 months after surgery]

    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

  1. Chronic Pain intensity and quality [3 months after surgery]

    Pain intensity of patients was evaluated by Arabic version of Brief pain inventory

  2. Neuropathic pain screening [3 months after surgery]

    Neuropathic pain will be screened by "Douleur Neuropathique 4" score

  3. Morphine consumption [0-24 hours after operation]

    Morphine rescue dose for extra need of analgesic

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anesthesia & Critical care department - National Institut of Oncology in Rabat. Ibn Sina teaching Hospital. Mohammed V university of Rabat Rabat Morocco 10100

Sponsors and Collaborators

  • Moroccan Society of Surgery

Investigators

  • Study Director: Abdelilah GHANNAM, MD, Mohammed V University in Rabat

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Moroccan Society of Surgery
ClinicalTrials.gov Identifier:
NCT05494281
Other Study ID Numbers:
  • USB_22 Trial
First Posted:
Aug 9, 2022
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 9, 2022