Pre-emptive analgesia of intrapleural and serratus plane blocks for breast surgeries: A randomized prospective clinical trial

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000034538
• Date of registration: 19/01/2015
• Prospective Registration: No
• Primary sponsor: Hoda Al Said Ahmed Ezz
• Public title: Pre-emptive analgesia of intrapleural and serratus plane blocks for breast surgeries: A randomized prospective clinical trial
• Scientific title: Pre-emptive Analgesia of intrapleural and serratus plane blocks on intra and post-operative analgesia for breast surgery patients
• Date of first enrolment: 16/08/2014
• Target sample size: 60
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000034538.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Phase 4

Countries of recruitment

Egypt

Contacts

• Name: Prof Abd El Reheem M. Dowidar

• Name: Prof Abd El Reheem M. Dowidar

Key inclusion & exclusion criteria

Inclusion criteria: Female patients with ASA clinical status I and II scheduled for breast surgery for any indication, e.g. breast cancer, cosmetic surgery, etc in the General Surgery Department, Tanta University Hospital, Egypt.
Exclusion criteria: Patients with pulmonary disease (empyema, chronic obstructive pulmonary disease, Pulmonary disease, or previous cardio-thoracic surgery), allergy to the local anesthetic, uncooperative patients, and patients with bleeding abnormalities.

Age minimum: 20 Years
Age maximum: 70 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Anaesthesiology - Pain management

Breast surgeries for any indication, e.g. breast cancer, cosmetic surgery, etc. ;
Breast surgeries for any indication, e.g. breast cancer, cosmetic surgery, etc.

Intervention(s)

30 patients in each group will be randomized using closed envelops and a computer generated random numbers into 2 groups (30 patients each). Each block will be performed just after induction of anesthesia. Group I (intrapleural block): While the patient is in the supine position, the block will be performed using number 18 Touhy needle at the 5th intercostal space in the anterior midaxillary line. The needle will be introduced while the patient is disconnected from the ventilator to avoid lung injury or pneumothorax. Loss of resistance technique will be used to identify the intrapleural space. After negative aspiration test 40 ml of 0.25% levobupivacaine will be injected in the intrapleural space.
Group II (serratus plane block):
The patients will be in the supine position, and the ultrasound probe will be in the sagital plane over the mid clavicular region , then we will go inferiorly and laterally till we identify the 5th rib in the mid axillary line to identify the latissimus dorsi, teres major and serratus muscles. 22G needle will be introduced in-plane in relation to the ultrasound probe, then 0.4 ml/kg levobupivacaine 0.25% will be injected in the potential space superficial to the serratus anterior muscle. In the intra-operative period; if signs of sympathetic stimulation (increase in heart rate and mean arterial blood pressure more than 20 % from the baseline values despite adequate level of anesthesia) treated with iv bolus doses of fentanyl 0.5 micogram /Kg.
In the post-operative period: Visual Analogue Score (VAS). 0 = no pain, to 10 = the most severe pain, 0-3 = mild pain , 4-6 = moderate pain, >6 = severe pain
Patients with moderate or severe pain will receive diclofenac sodium 75 mg intramuscular injection.
(VAS) will be record

Primary Outcome(s)

The quality of block
[ Will be assessed as follows:
Complete block: Patients who will not need fentanyl intra-operatively or diclofenac sodium injection 4 hours postoperatively.
Partial block: Patients who will need either fentanyl intra-operatively or diclofenac sodium injection 4 hours postoperatively.
Failed block: Patients who will need fentanyl intra-operatively and diclofenac sodium injection 4 hours postoperatively.
]

The duration of analgesia measured from the time of injection of the local anesthetic to the time of first request for analgesia (the first time the patient feels moderate or severe pain).[In the post-operative period: Visual Analogue Score (VAS). 0 = no pain, to 10 = the most severe pain, 0-3 = mild pain , 4-6 = moderate pain, >6 = severe pain.
(VAS) will be recorded at 1, 2, 4, 8, 12, 18,and 24 hours postoperatively.
]

Secondary Outcome(s)

Analgesic consumption[Dose of fentanyl and diclofenac sodium is assessed from the time of injection of the local anesthetic until 4 hours post-operatively.]

The occurrence of any complication related to the technique e.g pneumo-thorax, hemo-thorax.....etc will be recorded. [During performing the technique and the first 24 hours ]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Hoda Alsaid Ahmed Ezz

Secondary Sponsor(s)

Ahmed Abd El-Aziz Shama

Ethics review

Status: Approved
Approval date:
Contact:

Research Ethics Committee of the faculty of medicine ,Tanta Univerisity, Egypt.