Direct Versus US Guided PECS Block on Controlling Postmastectomy Pain

NCT05825430 | Completed DMC

• 1 other identifier: RC.5.1.2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Postmastectomy Pain

Keywords

Ultrasound guided pecs block; Direct pecs

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

  the amount of total postoperative morphine consumption

  24 hours postoperative

Secondary Outcomes (1)

• postoperative visual analogue scale (VAS)

  24 hours postoperatively

Study Arms (3)

Control group

EXPERIMENTAL

Patients will not receive any block

Drug: general anaesthetic technique only

Direct pecs block group

EXPERIMENTAL

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

Ultrasound guided pecs

EXPERIMENTAL

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

Interventions

Direct pecs block PROCEDURE

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.

Also known as: 10 ml bupivacaine 0.25%

Direct pecs block group

Ultrasound guided pecs block PROCEDURE

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.

Also known as: 10 ml bupivacaine 0.25%

Ultrasound guided pecs

general anaesthetic technique only DRUG

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.

Control group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years
• ASA I or II undergo elective simple mastectomy

You may not qualify if:

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

Sponsors & Collaborators

• Al-Azhar University: lead
• Benha University: collaborator

Study Sites (2)

Haney Baumey

Banhā, 13518, Egypt

Location

Neveen Kohaf

Tanta, 11865, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy

Study Record Dates

• First Submitted: April 9, 2023
• First Posted: April 24, 2023
• Study Start: April 15, 2023
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: August 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

EG (2)