Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Erector Spinae Plane Block: a Novel Technique for Postoperative Analgesia in Breast Cancer Surgery (erectspinae)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03769428
Recruitment Status : Completed
First Posted : December 7, 2018
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Ben marzouk Sofiene, University Tunis El Manar

Brief Summary:

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

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Ultrasound-guided Erector Spinae Plane Block: a Novel Technique for Postoperative Analgesia in Breast Cancer Surgery
Actual Study Start Date : December 17, 2018
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)

  • An intravenous patient controlled analgesia device will be given to the patients postoperatively
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


  5. 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.


  6. Postoperative nausea and vomiting [ Time Frame: within 24 hours postoperative ]
    Incidence of postoperative nausea and vomiting will be recorded.

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 25-65 years old
  • ASA I-II
  • Undergoing unilateral breast cancer surgery

Exclusion Criteria:

  • obesity (body mass index >40 kg/m2)
  • Preoperative chronic dependence upon opioid and NSAID medications
  • History of psychiatric or neurological disease
  • Patients with chronic pain syndromes
  • allergy to local anaesthetics
  • other contraindications to peripheral nerve blocks
  • Patients' refusal to participate

Information from the National Library of Medicine

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


Locations
Layout table for location information
Tunisia
Tunis maternity and neonatology center,
Tunis, Tunisia, 1007
Sponsors and Collaborators
Ben marzouk Sofiene
Investigators
Layout table for investigator information
Study Chair: Hayen Maghrebi, PROFESSOR UNIVERSITY OF TUNIS EL MANAR

Layout table for additonal information
Responsible Party: Ben marzouk Sofiene, clinical associate professor, University Tunis El Manar
ClinicalTrials.gov Identifier: NCT03769428     History of Changes
Other Study ID Numbers: erector-spinae
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ben marzouk Sofiene, University Tunis El Manar:
opioid consumption
erector spinae plane block
breast surgery
analgesia
PCA morphine
Locoregional anesthesia
breast cancer surgery

Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Agnosia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms