Direct Versus US Guided PECS Block on Controlling Postmastectomy Pain

NCT ID: NCT05825430

Last Updated: 2023-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-15
• Study Completion Date: 2023-06-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control group

Patients will not receive any block

Group Type: EXPERIMENTAL

general anaesthetic technique only

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Direct pecs block

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Ultrasound guided pecs block

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Other Intervention Names

10 ml bupivacaine 0.25%; 10 ml bupivacaine 0.25%

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: collaborator

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Neveen Abd El Maksoad Kohaf

Lecturer of Clinical Pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Haney Baumey

Banhā, , Egypt

Neveen Kohaf

Tanta, , Egypt

Countries

Egypt

Other Identifiers

RC.5.1.2023

Identifier Type: -

Identifier Source: org_study_id