Comparison of Efficacy of Regional Blocks in Breast Surgeries.

Shaukat Khanum Memorial Cancer Hospital & Research Centre

Status: Completed

Conditions: Pain Score; Morphine Consumption

Treatments: Procedure: Regional nerve blocks

Study type: Interventional

Funder types: Other

Identifiers

NCT07362472

IRB-23-11

Details and patient eligibility

About

After Standardized anesthetic induction patients were randomly given regional blocks. Group A recieved erecter spinae plane block & group B recieved combined serratous anterior and pecto-intercoatal facial plane block. Their mean morphine consumption were followed for the next 24 hours.

Full description

Subjects who are fulfilling the inclusion criteria will be included in the study after taking informed consent once approved by scientific review committee and Institutional review board.Subjects will be randomly divided into two groups by using a computer generated table using website Research Randomizer which will allocate the subjects randomly in two groups.Non probability consecutive sampling technique will used.Day cases are not included and major breast surgeries with post operative admission are included in study.Procedure will be done by the consultant having privilege to perform the block.Group A will be receiving ultrasound guided Erector spinae plane block before surgical incision with bupivacaine (maximum dose 2mg/kg) having total volume of 30ml. Group B will receive ultrasound guided combined serratus anterior plane block( in which local anesthetic is injected between the serratus anterior and latissimus dorsi muscles at level of 5th rib in mid to posterior axillary line)and pecto-intercostal plane block(in which local anesthetic is injected between the pectoral and intercostal muscle layer in 4th rib pecto-sternal region)before surgical procedure with same dose of bupivacaine (maximum dose 2mg/kg) with total volume of 30ml.Induction of anesthesia will be done before block using 2-3mg/kg Propofol, 0.5mg/kg Atracurium and placement of supraglottic airway device will be done in each group as part of standardization(5). Maintenance of anesthesia will be done with inhalational Sevoflurane, oxygen and air mixture. Every patient will be given Paracetamol 1g and Diclofenac 75mg for analgesia and dexamethasone 8mg if not contraindicated intraoperatively. Rescue analgesia with 0.05-0.1mg/kg Morphine will be administered intraoperatively in a titrated fashion to all those patients for pain with 20% increase in Heart rate and blood pressure from base line.Ondansetron(0.1mg/kg) IV as antiemetic and neostigmine/glycopyrrolate as a reversal agent will be used.Pain score will be assessed by RN registered nurse during first hour post operatively, at discharge from PACU using Numeric Rating Scale(NRS)and at 24 hours postoperatively on IPD using NRS and will be recorded in electronic record system of hospital. Any patient with a score of more than 3 will be administered IV morphine (0.1mg/kg). Post operative analgesic plan is multimodal with Paracetamol (1gm IV TID) and IV diclofenac 50mg BID (if no contraindication) along with opioid on PRN basis. All data will be recorded on a Performa from electronic record system (attached at the end).

Enrollment: 60 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female patients undergoing major breast cancer surgeries (modified radical mastectomy, breast reconstruction with implants).
• American society of anesthesiologist Grade 1 & 2
• Age between 18 to 45 years

Exclusion criteria

• Patient's refusal
• Emergency cases
• Patients having uncontrolled diseases like asthma, COPD or other lung diseases
• History of allergy from the drugs being used during the study
• Pregnant patients
• Patients with coagulopathies/bleeding disorders
• Patients undergoing bilateral major breast cancer surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Erecter spinae plane block

Active Comparator group

Description:

Ultrasound guided 30ml erecter spinae plane block was provided with standard bupivacaine (2mg/kg)

Treatment:

Procedure: Regional nerve blocks

serratous anterior plane block and pecto-intercoastal facial plane block

Active Comparator group

Description:

Ultrasound guided 30ml serratous anterior plane block and pecto-intercoastal facial plane block was provided with standard bupivacaine (2mg/kg)

Treatment:

Procedure: Regional nerve blocks