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Postoperative Analgesia in Breast Cancer Surgery: Safety and Efficiency of Ultrasound Guided Erector Spinae Plane Block (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 : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Ben marzouk Sofiene, University Tunis El Manar

Tracking Information
First Submitted Date  ICMJE November 27, 2018
First Posted Date  ICMJE December 7, 2018
Last Update Posted Date December 24, 2019
Actual Study Start Date  ICMJE December 17, 2018
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
  • 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 ]
    We 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 ]
    We 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 ]
    We will record and compare the timing of first rescue analgesia and total rescue analgesia requirement. If 6<VAS<8: paracetamol 1g iv will be administred If VAS>8:paracetamol 1g iv associated to ketoprofen100mg IM will be administred.
  • Total intraoperative consumption of Fentanyl. [ Time Frame: Intraoperative period ]
    We 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 occurance of morphine related side effects such as pruritus,urinary retention,hypotension,respiratory distress and sedation will be recorded.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Postoperative Analgesia in Breast Cancer Surgery: Safety and Efficiency of Ultrasound Guided Erector Spinae Plane Block
Official Title  ICMJE Postoperative Analgesia in Breast Cancer Surgery: Safety and Efficiency of Ultrasound Guided Erector Spinae Plane Block, a Randomized Controlled Double Blinded Trial
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.

Detailed Description

It is a prospective double blind trial. Sixty female patient aged between 20-65 years old with American Society of Anesthesiologists (ASA) physical status I-II and scheduled for elective surgery for breast cancer were included in the study. Only unilateral surgical procedures will be included. The patients will be randomized into two groups:

Group B (ESP block): Patients in the experimental arm will receive an ESPB prior to induction of general anesthetic.

Group P: (sham ESP block): Patients allocated to the placebo-control arm will receive a placebo injection of normal saline in almost identical fashion to that of the ESP block.

Intravenous access will be obtained with an 18-gauge intravenous (IV) cannula in the contralateral upper limb of the surgical site and monitors (pulse oximeter, electrocardiography, non-invasive blood pressure (NIBP) will be applied.

All blocks will be performed before induction of general anesthesia.

ESPB technique:

The ESPB will be done in the 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 a total of 40 mL of fluid will be injected next. The distribution will be observed in both cranial and caudal directions.

  • Group B (ESP block) will receive 150 mg of Ropivacaine : 40cc of Ropivacaine (3.75mg/cc).
  • Group P (Sham ESP block) will receive 40 cc of normal saline.

General Anesthesia:

All patients will receive pre-oxygenation with 100% O2 for 3 min. Anesthesia will be induced by using fentanyl 2μg/kg, Propofol 2-3 mg/kg and Atracurium 0.5 mg/kg. During anesthesia maintenance, monitoring will include Pulse Oximetry, an Electrocardiogram, Non-Invasive Blood Pressure (NIBP), end-tidal Carbon Dioxide, End-Tidal Sevoflurane, and Fraction of Inspired Oxygen.

The reinjection of 0.5μg/kg of 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.

Paracetamol 1 g IV and Ketoprofen 100 mg intramuscular (IM) will be administered for postoperative analgesia at the end of surgery. Anesthesia will be discontinued and tracheal extubation will be done once patient fulfilled the extubation criteria. In the recovery room, all patients will be given a patient-controlled analgesia device (PCA) containing morphine 1 mg/ml-1 ,set to deliver a 1 mg bolus dose of morphine, with an 5 min lockout time and 12mg 1 h limit. Postoperative pain will be assessed using a visual analogue scales (VAS) scores ranging from zero (no pain) to 10 (worst imaginable pain). The VAS scores will be recorded at 1,2,4,8 6, 12, 16, 20 and 24 h postoperatively.If VAS scores are superior to 6 the investigators will resort to rescue analgesia as following: If 6<VAS<8: paracetamol 1g IV will be administered and if VAS>8: paracetamol 1g IV associated to ketoprofen100mg IM.

Incidence of nausea and vomiting, and total morphine consumption during the 24-h postoperative period will be recorded.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer Surgery
  • Postoperative Analgesia
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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
    Intervention: Procedure: erector spinae plane block
  • 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

    Intervention: Procedure: sham erector spinae plane block
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 6, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 30, 2019
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tunisia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03769428
Other Study ID Numbers  ICMJE erector-spinae
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ben marzouk Sofiene, University Tunis El Manar
Study Sponsor  ICMJE Ben marzouk Sofiene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Hayen Maghrebi, PROFESSOR UNIVERSITY OF TUNIS EL MANAR
PRS Account University Tunis El Manar
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP