Direct Versus US Guided PECS Block on Controlling Postmastectomy Pain

Postmastectomy Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05825430
• Other study ID #: RC.5.1.2023
• Status: Completed
• Phase: N/A
• Start date: April 15, 2023
• Est. completion date: June 15, 2023

Study information

• Verified date: August 2023
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Postmastectomy Pain

Intervention

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.
• 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.

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.

Locations

Country	Name	City	State
Egypt	Haney Baumey	Banha
Egypt	Neveen Kohaf	Tanta

Sponsors (2)

Lead Sponsor	Collaborator
Al-Azhar University	Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine consumption	the amount of total postoperative morphine consumption	24 hours postoperative
Secondary	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