Serratus Anterior Plane (SAP) Block vs SAP Block Combined With Transverus Thoracic Plane (TTP) Block, for Post-mastectomy Pain Control.

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Procedure: Serratus anterior plane block; Procedure: Transversus thoracic plane block

• Registration Number: NCT04375111
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2020-05-01
• Study First Submitted QC: 2020-05-04
• Study First Posted: 2020-05-05
• Study Start: 2021-06-15
• Primary Completion: 2022-03-15
• Study Completion: 2022-04-30
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-01
• Last Update Posted: 2022-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SAP block for management of post-mastectomy pain	Serratus anterior plane block	the patients in this group shall undergo Serraturs anterior plane block for management of post-mastectomy pain.
TTP block combined with SAP block for post-mastectomy pain	Serratus anterior plane block	the patients in this group shall undergo combined Serraturs anterior plane block, and Transversus thoracic plane block for management of post-mastectomy pain.
TTP block combined with SAP block for post-mastectomy pain	Transversus thoracic plane block	the patients in this group shall undergo combined Serraturs anterior plane block, and Transversus thoracic plane block for management of post-mastectomy pain.

Primary Outcome Measures

Name	Time	Method
Total sum of used IV additional opioid analgesia.	24 hours post-operatively	If the patient experiences a pain of \> 3, IV morphine will be given at a dose of 2.5-5 mg per dose, with a maximum dose of 10 mg, aiming for a pain score of ≤ 3. the total morphine dose for the post-operative 24 hours will be compared between the case and control group, in order to determine which technique provided more analgesia.

Secondary Outcome Measures

Name	Time	Method
Post-operative pain score	24 hours post-operatively	VAS (Visual Analogue Scale, 0-100 mm; where 0 = no pain, and 100 = worst imaginable pain) will be assessed, at rest, per hour for 24 hours post operatively. Moreover, VAS will also be assessed at 12 and 24 hours post-operatively while abducting the ipsilateral arm. If the patient experiences a pain of \> 3, IV morphine will be given at a dose of 2.5-5 mg per dose, with a maximum dose of 10 mg, aiming for a pain score of ≤ 3.

Trial Locations

Locations (1)

South Egypt Cancer Institute, Assiut University; 🇪🇬 Assiut, Egypt