Skip to main content
OpenTrials
Completed

NCT Number: NCT04375111

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

South Egypt Cancer Institute, Assiut University

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Serratus Anterior Plane Block

Procedure

•Serratus anterior plane block will be carried out with the patient lying in the lateral position. After skin disinfection, the ultrasound probe will be applied parallel to and between the 5th and 6th ribs in the mid axillary region, for identification of the superficial latissimus dorsi muscles and deep anterior serratus muscles. Then, 25 ml of isobaric bupivacaine 0.25% will be injected above the serratus anterior muscle.

Other names: SAP block

Transversus Thoracic Plane Block

Procedure

•Transversus thoracic plane block will be carried out with the patient lying in the supine position. After skin disinfection, the ultrasound probe will be applied parallel to and between the 4th and 5th ribs connecting at the sternum. Then, 15 ml of isobaric bupivacaine 0.25% will be injected between the transversus thoracic muscle and the internal intercosatal muscle.

Other names: TTP block

Primary outcomes

  1. Total sum of used IV additional opioid analgesia.

    Time frame: 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 outcomes

  1. Post-operative pain score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 5, 2020
Registry last updated
Jun 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.