Single Path Versus Double Path PECS I and II Blocks as an Efficient Analgesic Choice in Female Breast Surgeries.

NCT04061668 | Completed

• 1 other identifier: FMASU R 04/ 2019
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The patients are allocated by computer generated random number method into 2 groups: single needle path PECS I and II block group, where patients receive induction with pec I and II blocks which are performed under ultrasound guidance , with a linear ultrasound transducer on the same side of surgery. The patients are placed in the supine position where the elbow was flexed and shoulder will be abducted. The probe is placed inferior to the clavicle . A linear probe and a beveled tip needle will be introduced with an in-plane technique . The US probe is initially placed below outer third of the clavicle after skin sterilization showing pectoralis major and minor muscles and the thoraco- acromial artery then moved infero-laterally to locate fourth rib where pectoralis major and pectoralis minor muscles are visualised . The US probe is then moved toward anterior axillary line till pectoralis minor and serratus anterior muscles are identified at 4th rib at the level of thoraco-acromial artery then the needle is inserted in plane with the probe from caudal to cranial using an inclined manner, 15mL of bupivacaine will be put into the potential space between pectoralis minor muscle and serratus muscle (PECS II) then it will be withdrawn to inject another 15 ml of bupivacaine in the plane between pectoralis muscles . The block will be performed with needle introduced in-plane with the ultrasound probe, and the local anesthetic (LA) injection is visualized . In double needle path PECS I and II block group The probe is initially placed below outer third of the clavicle after skin sterilization showing pectoralis major and minor muscles and the thoraco- acromial artery then moved inferolaterally to locate fourth rib where pectoralis major and pectoralis minor muscles are visualised, then the needle is inserted in plane with the probe and 15mL of bupivacaine is put into the potential space between pectoralis muscles. In the second puncture , the probe is moved toward anterior axillary line till pectoralis minor and serratus anterior muscles will be identified at 4th rib at the level of thoraco-acromial artery then the needle will be inserted in plane with the probe from caudal to cranial , 15mL of bupivacaine is put into the potential space between pectoralis minor muscle and serratus muscle (PECS II).

Conditions

Analgesia

Keywords

PECS; bupivacaine

Outcome Measures

Primary Outcomes (1)

• time of performance of each technique

  duration of performance of each technique

  10 to 15 minutes

Secondary Outcomes (1)

• total dose of postoperative fentanyl consumed

  24 hours after the procedure

Study Arms (2)

single needle path PECS I and II block group(

OTHER

The probe is placed inferior to the clavicle . A probe and needle is introduced with in-plane technique . The US is placed below outer third of the clavicle showing pectoralis major and minor muscles then moved infero-laterally to locate fourth rib where pectoralis major and pectoralis minor muscles is visualised . The US probe is moved toward anterior axillary line till pectoralis minor and serratus anterior muscles will be identified at 4th rib at the level of thoraco-acromial artery then the needle is inserted from caudal to cranial using an inclined manner, 15mL of bupivacaine 0.25% is put between pectoralis minor muscle and serratus muscle (PECS II) then it is withdrawn to inject 15 ml of bupivacaine in thel plane between pectoralis muscles . The block will be performed with needle introduced in-plane with the ultrasound probe, and the local anesthetic injection will be visualized .

Other: single needle path PECS I and II block group

double needle path PECS I and II block group

SHAM COMPARATOR

The probe will be placed below outer third of the clavicle showing pectoralis major and minor muscles and the thoraco- acromial artery then moved inferolaterally to locate fourth rib where pectoralis major and pectoralis minor muscles are visualised, then the needle is inserted in plane with probe and 15mL of bupivacaine are put into between pectoralis muscles. In the second puncture , the US probe is moved toward anterior axillary line till pectoralis minor and serratus anterior muscles are identified , the needle will be inserted in plane with the probe from caudal to cranial , 15mL of bupivacaine will be put into the potential space between pectoralis minor muscle and serratus muscle (PECS II).

Other: double needle path PECS I and II block group

Interventions

single needle path PECS I and II block group OTHER

The probe is placed inferior to the clavicle . The US probe is placed below outer third of the clavicle showing pectoralis major and minor muscles and the thoraco- acromial artery then moved infero-laterally to locate fourth rib where pectoralis major and pectoralis minor muscles will be visualised . The probe is moved toward anterior axillary line till pectoralis minor and serratus anterior muscles ise identified at 4th rib at the level of thoraco-acromial artery , the needle is inserted in plane with the probe from caudal to cranial using an inclined manner, 15mL of bupivacaine is put into the potential space between pectoralis minor muscle and serratus muscle (PECS II) then it is withdrawn to inject another 15 ml of bupivacaine in the plane between pectoralis muscles . The block will be performed with needle introduced in-plane with the ultrasound probe, and the local anesthetic injection is visualised.

Also known as: single needle path PECS I and II block

single needle path PECS I and II block group(

double needle path PECS I and II block group OTHER

The US probe will be initially placed below outer third of the clavicle after skin sterilization showing pectoralis major and minor muscles and the thoraco- acromial artery then moved inferolaterally to locate fourth rib where pectoralis major and pectoralis minor muscles will be visualised, then the needle will be inserted in plane with the probe and 15mL of bupivacaine 0.25% after negative aspiration will be put into the potential space between pectoralis muscles. In the second puncture , the US probe will be moved toward anterior axillary line till pectoralis minor and serratus anterior muscles will be identified at 4th rib at the level of thoraco-acromial artery then the needle will be inserted in plane with the probe from caudal to cranial in an inclined way, 15mL of bupivacaine 0.25% after negative aspiration will be put into the potential space between pectoralis minor muscle and serratus muscle (PECS II).

Also known as: double needle path PECS I and II block

double needle path PECS I and II block group

Eligibility Criteria

• Age: 50 Years - 65 Years
• Gender Eligibility Details: recruitment of patients is based on representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female patients aged from 50-65 years old elective breast surgeries ASA I II

You may not qualify if:

• Refusal to participate inability to communicate with the investigators or hospital staff obesity (body mass index\>40 kg/m2) patients undergoing bilateral surgery male patients renal insufficiency (creatinine\>1.5 mg/dL) American Society of Anesthesia (ASA) III-IV patients with incomplete medical records

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams U

Cairo, 11566, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Nahed Effat

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Anesthesia

Study Record Dates

• First Submitted: August 17, 2019
• First Posted: August 20, 2019
• Study Start: November 10, 2019
• Primary Completion: June 30, 2020
• Study Completion: July 2, 2020
• Last Updated: August 3, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 7 months
• Access Criteria: Descriptive statistics will be carried out for numerical parametric data and presented as mean±SD, whereas categorical data will be presented as number and percentage. Variables such as demographic data andcomorbidities will be compared using the χ2-test

Locations

EG (1)