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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04908878
Other study ID # 33972/7/20
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date June 2, 2022

Study information

Verified date November 2022
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate the analgesic efficacy of combined ultrasound (US)-guided pectoral nerve (PECS) block II and transversus thoracic plane (TTP) block versus US-guided serratus anterior plane (SAP) block in female patients undergoing modified radical mastectomy.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date June 2, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 21 Years to 60 Years
Eligibility Inclusion Criteria: - Female patients - Aged 21-60 years - ASA physical status I, II - Scheduled for unilateral modified radical mastectomy Exclusion Criteria: 1. Patient refusal. 2. Known hypersensitivity to local anesthetics. 3. Body mass index > 35 kg /m2. 4. Uncooperative or psychiatric patients. 5. Infection at the injection site. 6. Coagulation disorder.

Study Design


Intervention

Procedure:
Pectoral nerve (PECS) block -transversus thoracic plane (TTP) block
Patients will receive unilateral US-guided PECS II block and TTP block on the side of the operation after induction of general anesthesia.
Serratus anterior plane (SAP) block
Patients will receive US-guided SAP block after induction of general anesthesia.

Locations

Country Name City State
Egypt Faculty of Medicine Tanta University Tanta Elgharbia

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary The total amount rescue analgesic consumption (morphine) in the first 24 hours postoperatively. Rescue analgesia in the form of morphine (3mg IV) will be given if the VAS is = 40, repeated with lock out interval of 5 min guided with the occurrence of complications till the VAS is decreased to less than 40. First 24 hours postoperatively.
Secondary The degree of postoperative pain Postoperative pain will be assessed by Visual Analog scale (VAS) on admission to Post-Anesthesia Care unit (PACU) and at 30 minutes and then 1,2,4,6,12,18 and 24 hours postoperative.
VAS (0-100; where 0 represents no pain and 100 represents the worst pain).
First 24 hours postoperatively.
Secondary Time to first rescue analgesia request. Rescue analgesia in the form of morphine (3mg IV) will be given if the VAS is = 40, repeated with lock out interval of 5 min guided with the occurrence of complications till the VAS is decreased to less than 40. First 24 hours postoperatively.
Secondary Intraoperative fentanyl consumption. Additional boluses of fentanyl 0.5 µg /kg will be administered in case of inadequate analgesia that defined as increase of heart rate (HR) and /or mean arterial blood pressure (MAP) more than 20 % from baseline Intraoperative
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