Direct Versus US Guided PECS Block on Controlling Postmastectomy Pain

Direct Versus Ultrasound Guided PECS Block Effect on Controlling Postmastectomy Pain: A Prospective, Randomized, Single Blinded, Controlled Study.

Perioperative analgesia for surgery in carcinoma breast utilizes significant quantities of opioids as compared to cosmetic breast surgeries. Regional anesthesia reduces the need for perioperative opioids and thus may improve the outcome. The investigators decided to perform the modified pectoral nerve block ( Pec II) under vision after resection of tumor, without ultrasound and compare the postoperative analgesic and opioid sparing effects of the nerve block with ultrasound guided modified pectoral nerve block (Pec) in patients undergoing modified radical mastectomy.

Study Overview

• Status: Completed
• Conditions: Postmastectomy Pain
• Intervention / Treatment: Drug: general anaesthetic technique only; Procedure: Direct pecs block; Procedure: Ultrasound guided pecs block

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Banhā, Egypt, 13518
    • Haney Baumey
  • Tanta, Egypt, 11865
    • Neveen Kohaf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 20 - 50 years
• ASA I or II undergo elective simple mastectomy

Exclusion Criteria:

• patients with diabetes mellitus i
• Intradialytic hypotension,
• chronic kidney disease and Bronchial Asthma

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control group; Patients will not receive any block	Drug: general anaesthetic technique only; All patients will receive the same general anaesthetic technique: In the form of iv induction by propofol 2mg /kg ,fentanyl 2 mic/ kg and intubation will be facilitated by atracurium 0.5 mg/kg. Anaesthesia will be maintained by isoflurane 1.5 MAC and incremental doses of atracurium 0.15 mg/kg every 20 min. At the end of surgery neuromuscular blocker reversed by neostigmine 50 micg/kg + atropine 20 micg /kg i.v.
Experimental: Direct pecs block group; Pec I block will be given with 10 ml bupivacaine 0.25% which injected between two pectoral muscles and pecs II block will be given with 20 ml bupivacaine 0.25%.which given between pectoralis minor muscle and serratus muscle. Patients will receive direct pecs block by surgeon after closure of pectoralis muscle under direct vision and before skin closure.	Procedure: Direct pecs block; Patients will receive direct PECS block by surgeon after closure of pectoralis muscle under direct vision and before skin closure. All patients will receive the same general anaesthetic technique: In the form of iv induction by propofol 2mg /kg ,fentanyl 2 mic/ kg and intubation will be facilitated by atracurium 0.5 mg/kg. Anaesthesia will be maintained by isoflurane 1.5 MAC and incremental doses of atracurium 0.15 mg/kg every 20 min. At the end of surgery neuromuscular blocker reversed by neostigmine 50 micg/kg + atropine 20 micg /kg i.v.; Other Names: 10 ml bupivacaine 0.25%
Experimental: Ultrasound guided pecs; Pec I block will be given with 10 ml bupivacaine 0.25% which injected between two pectoral muscles and pecs II block will be given with 20 ml bupivacaine 0.25%.which given between pectoralis minor muscle and serratus muscle. Patients will receive ultrasound guided pecs block done after induction and before skin incision.	Procedure: Ultrasound guided pecs block; Patients will receive ultrasound guided pecs block after induction and before skin incision. All patients will receive the same general anaesthetic technique: In the form of iv induction by propofol 2mg /kg ,fentanyl 2 mic/ kg and intubation will be facilitated by atracurium 0.5 mg/kg. Anaesthesia will be maintained by isoflurane 1.5 MAC and incremental doses of atracurium 0.15 mg/kg every 20 min. At the end of surgery neuromuscular blocker reversed by neostigmine 50 micg/kg + atropine 20 micg /kg i.v.; Other Names: 10 ml bupivacaine 0.25%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total morphine consumption	the amount of total postoperative morphine consumption	24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative visual analogue scale (VAS)	The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 "no pain" and 10 "worst pain.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Collaborators: Benha University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2023
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: April 9, 2023
• First Submitted That Met QC Criteria: April 21, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Ultrasound guided pecs block; Direct pecs
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Local; Anesthetics; Bupivacaine; Anesthetics, General
• Other Study ID Numbers: RC.5.1.2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data could be shared upon a reasonable request from the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No