Clinical trial NCT04375111: Serratus Anterior Plane (SAP) Block vs SAP Block Combined With Transverus Thoracic Plane (TTP) Block, for Post-mastectomy Pain Control.
Official title: Comparison Between Serratus Anterior Plane Block, and Transversus Thoracic Plane Block Combined With Serratus Anterior Plane Block, for the Management of Post-mastecomy Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: serratus anterior plane block
transversus thoracic plane block
post-mastectomy pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 54
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: a comparison shall be conducted between Serratus anterior plane block, on one hand, and transversus thoracic plane block combined with Serratus anterior plane block, on the other hand for management of post-mastectomy pain. VAS "Visual Analogue Scale" score will be compared in both case, and control groups.

Detailed description: Breast cancer is one of the most common cancers in women all over the world. In the united states, according to the CDC "Center of Disease Control", it's the second most common cancer occurring in women. Perioperative pain after breast surgeries remains to be taken lightly due to the minimal invasiveness of breast surgeries. However, it is estimated that 25-60% of patients undergoing breast cancer related surgeries develop chronic pain. Acute post-operative pain remains an important risk factor in developing chronic post-mastectomy pain; about 40% of women will have acute post-operative pain, on the other hand, 50% will have chronic pain. Different regional anaesthesia techniques have achieved better management of post-breast surgery acute pain and subsequently less frequent chronic pain. Add to that, effective regional anaesthesia will decrease both the surgical stress response and the requirements of general anaesthetics and opioids, which will keep the function of the immune system intact. A lot of regional anaesthesia techniques have been used to control anterior chest wall pain as the pectoral nerves (PECs) block, paravertebral block, intercostal nerve blocks, thoracic epidural analgesia, serratus anterior plane block. The breast receives its innervation through the anterior and lateral cutaneous branches of the 2nd to the 6th intercostal nerves. Targeting the serratus plane is a safer and a simpler procedure than multiple intercostal or paravertebral blocks. As a setback for the serratus anterior plane block, it only blocks the lateral cutaneous branches of the intercostal nerves with minimal if any effect on the anterior cutaneous branches. The serratus anterior plane block, being unable to block the anterior cutaneous branches of the intercostal nerves, have to be combined with another technique, transversus thoracic plane block, which can block them. The investigators here are trying to measure the efficacy of the combined serratus anterior plane block and tranversus thoracic plane block on the management of post-mastectomy pain.

Eligibility criteria: Inclusion Criteria:

* Adult female patients \> 30 years old, ASA "American Society of Anaesthesiologists" physical status I or II undergoing any unilateral mastectomy.

Exclusion Criteria:

* Patient's refusal.
* Known contraindications to regional blocks, including local skin infections,and coagulopathy.
* Allergies to the local anaesthetics used.

Primary outcomes:
measure: Total sum of used IV additional opioid analgesia.
timeFrame: 24 hours post-operatively
Secondary outcomes:
measure: Post-operative pain score
timeFrame: 24 hours post-operatively
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: South Egypt Cancer Institute, Assiut University
Study officials:
affiliation: Assiut University Hospitals
name: Zein El-Abdeen Z Hassan, Professor
role: STUDY_CHAIR
affiliation: South Egypt Cancer Institute, Assiut University Hospitals.
name: Montasser A Mohamed, A.Professor
role: STUDY_DIRECTOR
affiliation: South Egypt Cancer Institute, Assiut University Hospitals.
name: Ahmed H Othman, A.Professor
role: STUDY_DIRECTOR
affiliation: South Egypt Cancer Institute, Assiut University Hospitals.
name: Ahmed W Mohamed Shamsedine, MBBCH
role: PRINCIPAL_INVESTIGATOR
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