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Clinical Trials/NCT07362472
NCT07362472
Completed
Not Applicable

Comparison of Efficacy of Erector Spinae Plane Block Vs Combined Serratus Anterior Plane Block and Pecto-intercostal Fascial Plane Block in Patients Undergoing Breast Cancer Surgery

Shaukat Khanum Memorial Cancer Hospital & Research Centre1 site in 1 country60 target enrollmentStarted: November 7, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Shaukat Khanum Memorial Cancer Hospital & Research Centre
Enrollment
60
Locations
1
Primary Endpoint
mean morphine consumption

Overview

Brief Summary

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.

Detailed 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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Masking Description

Interventional regional blocks were provided by consultants with privileges of nerve blocks. Patients, investigators and nursing staff accessing pain score were blinded from the intervention.

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Erecter spinae plane block

Active Comparator

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

Intervention: Regional nerve blocks (Procedure)

serratous anterior plane block and pecto-intercoastal facial plane block

Active Comparator

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

Intervention: Regional nerve blocks (Procedure)

Outcomes

Primary Outcomes

mean morphine consumption

Time Frame: 24 hours

We calculated and compared mean morphine consumption in first 24 hours post operatively among the 2 groups.

Secondary Outcomes

  • Pain score(24 hours)

Investigators

Sponsor
Shaukat Khanum Memorial Cancer Hospital & Research Centre
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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