Direct Versus US Guided PECS Block on Controlling Postmastectomy Pain

Sponsor

Al-Azhar University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05825430

Collaborator

Benha University (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postmastectomy Pain	Procedure: Direct pecs block Procedure: Ultrasound guided pecs block Drug: general anaesthetic technique only	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Apr 15, 2023

Anticipated Primary Completion Date :

Jun 15, 2023

Anticipated Study Completion Date :

Jun 15, 2023

Arms and Interventions

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%

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%

Outcome Measures

Primary Outcome Measures

Total morphine consumption [24 hours postoperative]
the amount of total postoperative morphine consumption

Secondary Outcome Measures

postoperative visual analogue scale (VAS) [24 hours postoperatively]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Haney Baumey	Banhā		Egypt	13518
2	Neveen Kohaf	Tanta		Egypt	11865

Sponsors and Collaborators

Al-Azhar University
Benha University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Neveen Abd El Maksoad Kohaf, Lecturer of Clinical Pharmacy, Al-Azhar University

ClinicalTrials.gov Identifier:

NCT05825430

Other Study ID Numbers:

RC.5.1.2023

First Posted:

Apr 24, 2023

Last Update Posted:

Apr 24, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Neveen Abd El Maksoad Kohaf, Lecturer of Clinical Pharmacy, Al-Azhar University

Ultrasound guided pecs block

Direct pecs

Additional relevant MeSH terms:

Bupivacaine

Anesthetics

Anesthetics, General

Study Results

No Results Posted as of Apr 24, 2023