Postoperative Analgesia in Breast Cancer Surgery: Safety and Efficiency of Ultrasound Guided Erector Spinae Plane Block (erectspinae)
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|ClinicalTrials.gov Identifier: NCT03769428|
Recruitment Status : Completed
First Posted : December 7, 2018
Last Update Posted : December 24, 2019
Breast cancer surgery is one of the most common surgeries, due to the high incidence of breast cancer. Unfortunately, patients experience significant postoperative acute pain, placing them at risk for increased clinical morbidity and the development of disabling chronic pain which may rich up to 55% . The intensity of perioperative pain experienced by the patient is one of the best predictors of chronic pain.
However, postoperative analgesia in breast cancer surgery is difficult due to the extensive nature of the surgery and the complex innervation of the breast.
Several newly described regional anesthesia techniques exist to control perioperative pain, including the Paravertebral block (PVB) which has been proved to be the most effective one. The anatomic proximity of the pleura and central neuraxial system makes it a particularly challenging technique and carrying a risk of pneumothorax.
The Erector Spinae Plane Block (ESPB) is a novel interfascial plane block described by Forero et al in September 2016. Local anesthetic injection is performed beneath the erector spinae muscle. Local anesthetic (LA) expected to achieve paravertebral spread of three vertebral levels cranially and four levels caudally, blocking the dorsal and ventral rami of the spinal nerves.The easy, fast and safe execution of ESPB makes it a promising technique in the context of surgical pain during breast cancer surgery.
There is no sufficient randomized controlled trials that assess the effectiveness of ESPB in controlling post-operative breast surgery pain.
The main purpose of this study is to evaluate the postoperative analgesic effect of Ultrasound-guided ESPB in patients undergoing breast cancer surgery.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Surgery Postoperative Analgesia||Procedure: erector spinae plane block Procedure: sham erector spinae plane block||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Postoperative Analgesia in Breast Cancer Surgery: Safety and Efficiency of Ultrasound Guided Erector Spinae Plane Block, a Randomized Controlled Double Blinded Trial|
|Actual Study Start Date :||December 17, 2018|
|Actual Primary Completion Date :||June 30, 2019|
|Actual Study Completion Date :||June 30, 2019|
Active Comparator: group B:ESP block
Patients in the experimental arm will receive an erector spinae plane block prior to induction of general anesthetic :- 150 mg of Ropivacaine : 40cc of Ropivacaine (3.75mg/cc)
Procedure: erector spinae plane block
The ESPB will be done in a sitting position using linear ultrasound probe (L10) of MySonoU6 machine. The blocks will be performed at the T4-T5 level of the spine using an in-plane approach. A linear probe will be placed 2-3 cm laterally to the spine using a sagittal approach. Three muscles will be identified superficial to the transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. Local anesthetic (LA) is injected between the erector spinae muscle and transverse process. Following confirmation of the correct position of the needle tip with administration of 0.5-1 ml of the fluid. Then 40cc of Ropivacaine (3.75mg/cc) will be injected .The distribution will be observed in both cranial and caudal directions.
Placebo Comparator: group P: Sham ESP block
Patients allocated to the placebo-control arm will receive a sham erector spinae plane block .they will receive a placebo injection of normal saline in a fashion almost identical to that of the ESP block:- 40 cc of normal saline will be injected
-An intravenous patient controlled analgesia device will be given to the patients postoperatively
Procedure: sham erector spinae plane block
The sham ESPB will be done in a sitting position using linear ultrasound probe (L10) of MySonoU6 machine. The blocks will be performed at the T4-T5 level of the spine using an in-plane approach. A linear probe will be placed 2-3 cm laterally to the spine using a sagittal approach. Three muscles will be identified superficial to the transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. Following confirmation of the correct position of the needle tip with administration of 0.5-1 ml of the fluid a total of 40 mL of fluid will be injected next between the erector spinae muscle and transverse process. Then 40cc of normal saline will be injected.The distribution will be observed in both cranial and caudal directions.
- Comparing morphine consumption rates within 24h postoperative [ Time Frame: The first 24 hours postoperative ]All patients will be provided with IV morphine PCA and morphine consumption within 24 hour postoperatively will be recorded for both groups.
- Assessment of pain in postoperative period via visual analogue scales (VAS) . [ Time Frame: The first 24 hours postoperative ]Postoperative pain will be assessed using a VAS ranging from 0 (no pain) to 10 (worst imaginable pain).The VAS will be recorded at 1,2,4,8 6, 12 ,16,20 and 24 h postoperatively.
- Total morphine demand [ Time Frame: During 24 hours postoperative ]The investigators will compare total morphine demand in both groups during the first 24h after surgery.
- Time to first request for morphine [ Time Frame: During 24 hours postoperative ]The investigators will compare the timing of the first request for morphine in both groups during the first 24h after surgery.
- Requirement of rescue analgesia [ Time Frame: During 24 hours postoperative ]
The investigators will record and compare the timing of first rescue analgesia and total rescue analgesia requirement.
If 6<VAS<8: paracetamol 1g iv will be administered If VAS>8:paracetamol 1g iv associated to ketoprofen100mg IM will be administered.
- Total intraoperative consumption of Fentanyl. [ Time Frame: Intraoperative period ]
The investigators will record the total dose of Fentanyl (µg) required during surgery.
Fentanyl will be given intraoperatively either when heart rate or Non-Invasive Blood Pressure (NIBP) report an increase by more than 20% of the basal records.
- Postoperative nausea and vomiting [ Time Frame: within 24 hours postoperative ]Incidence of postoperative nausea and vomiting will be recorded.
- Morphine related side effects [ Time Frame: During 24 hours postoperative ]The occurence of morphine related side effects such as pruritus,urinary retention,hypotension,respiratory distress and sedation will be recorded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769428
|Tunis maternity and neonatology center,|
|Tunis, Tunisia, 1007|
|Study Chair:||Hayen Maghrebi, PROFESSOR||UNIVERSITY OF TUNIS EL MANAR|