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Completed

NCT Number: NCT04108715

Erector Spina Plane Block Versus Deep Serratus Anterior Plane Block for Post Mastectomy Analgesia

Breast cancer surgery like Mastectomy and modified radical mastectomy are associated with significant postoperative pain, and management depends largely on patient controlled analgesia with intravenous Morphine or other opioids equivalents. Respiratory depression, Ileus, sedation, nausea and vomiting are some of the potential side effect of opioid treatment which prolonged hospital length of stay and increase the coast. Recent advance in ultrasound guided regional anesthesia has led to the development of two novel regional anesthesia techniques specific to chest wall analgesia; Erector spina plain block and Serratus anterior plain block, with its potential to reduce or eliminate the need for opioids to manage post-operative pain.

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Key information

Conditions

Mastectomy

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

King Saud University

Riyadh, P.o.Box 7805, 11472, Saudi Arabia

About this study

Experimental: erector spinae plain block After giving general anesthesia, patient is positioned in lateral decubitus with the surgical side up, and prepping para-spinous area with antiseptic solution. Ultrasound high frequency linear transducer is positioned in a para-sagittal plane at the level of fifth thoracic vertebra. Scanning of interested structures from superficial to deep planes, Trapezius muscle, Rhomboid major muscle, Erector spina muscle and transverse process of fifth thoracic vertebra.

Comparator: serratus anterior plane block After giving general anesthesia, patient is positioned in lateral decubitus, with the surgical side up. The upper arm is abducted and elevated above the head level. Under sterile aseptic technique, a linear ultrasound transducer (6-15 MHz) is placed in a sagittal oblique plane over the fourth and fifth ribs at the mid-axillary line. The following muscles are identified overlying the fourth/ fifth rib: the latissimus dorsi (superficial) and serratus anterior muscle (deep) overlying the ribs.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA I-III patients age 18 to 75 years undergoing unilateral breast surgery

Exclusion criteria

  • Patients refusal
  • History of amide local anesthetics allergy
  • Alcohol or drug abuse
  • Chronic opioid intake
  • Language barriers
  • Patient with psychiatric disorders
  • Contraindications for regional anesthesia
  • BMI > 40 Kg/m2
  • Obstructive sleep apnea that preclude PCA opioids

Treatment and study plan

Erector spina plain block for mastectomy analgesia

Procedure

After giving general anesthesia, patient is positioned in lateral decubitus with the surgical side up, An erector Spina plain block is performed with inserting block needle (Pajunk, Geisingen, Germany) in-plane under ultrasound control until needle tip hits the transverse process, a volume of 0.3 ml/kg of bupivacaine 0.25% (Marcaine, Astra Zeneca Pharmaceuticals) is injected. Pain management assessment and analgesic consumption will be provided through patient-controlled analgesia (PCA) for 24 hours. The PCA pump is programmed to deliver 1 mg morphine bolus per press with a lockout interval of 10 min. Pain scores will be measured using eleven points numerical rating scale NRS (0 to 10) and opioids consumption will be documented at 0, 1, 4, 8 and 24 hours. Time of admission to post-anesthesia care unit PACU is considered 0 hours. Any opioid equivalents given during the first 24 hours to manage breakthrough pain will be documented

Deep serratus anterior plane block

Procedure

After giving general anesthesia, the patient is positioned in lateral decubitus, with the surgical side up. The upper arm is abducted and elevated above the head level. A block needle is introduced in-plane, targeting the plane deep to the serratus anterior muscle, and a bolus of 0.3 ml/kg bupivacaine 0.25% is injected through ultrasound guidance. Pain management assessment and analgesic consumption will be provided through patient-controlled analgesia PCA for 24 hours. The PCA pump is programmed to deliver 1 mg morphine bolus per press with a lockout interval of 10 min. Pain scores will be measured using eleven points numerical rating scale NRS (0 to 10), and opioids consumption will be documented at 0, 1, 4, 8 and 24 hours. Time of admission to PACU is considered 0 hours. Any opioid equivalents given during the first 24 hours to manage breakthrough pain will be documented

Primary outcomes

  1. Cumulative Opioid consumption in the first 24 hours.

    Time frame: 0 hours post- operative( 0 time is considered time to admission to post anesthesia care unit)

    Post- operative morphine consumption measured from patient controlled analgesia pump (PCA machine)

  2. Cumulative Opioid consumption in the first 24 hours.

    Time frame: 1 hour post-operative

    Post- operative morphine consumption measured from patient controlled analgesia pump (PCA machine)

  3. Cumulative Opioid consumption in the first 24 hours.

    Time frame: 4 hours post-operative

    Post- operative morphine consumption measured from patient controlled analgesia pump (PCA machine)

  4. Cumulative Opioid consumption in the first 24 hours.

    Time frame: 8 hours post-operative

    Post- operative morphine consumption measured from patient controlled analgesia pump (PCA machine)

  5. Cumulative Opioid consumption in the first 24 hours.

    Time frame: 24 hours post-operative

    Post- operative morphine consumption measured from patient controlled analgesia pump (PCA machine)

  6. Post-operative pain intensity

    Time frame: pain at 0 hour, 0 time is considered time to admission to post anesthesia care unit

    pain intensity is measured by ( 11 point numerical scale from 0 to 10), where 0 is considered no pain, 10 is the worst pain

  7. Post-operative pain intensity

    Time frame: pain at 1 hour post operative

    pain intensity is measured by ( 11 point numerical scale from 0 to 10), where 0 is considered no pain, 10 is the worst pain

  8. Post-operative pain intensity

    Time frame: pain at 4 hours post operative

    pain intensity is measured by ( 11 point numerical scale from 0 to 10), where 0 is considered no pain, 10 is the worst pain

  9. Post-operative pain intensity

    Time frame: pain at 8 hours post operative

    pain intensity is measured by ( 11 point numerical scale from 0 to 10), where 0 is considered no pain, 10 is the worst pain

  10. Post-operative pain intensity

    Time frame: pain at 24 hours post operative

    pain intensity is measured by ( 11 point numerical scale from 0 to 10), where 0 is considered no pain, 10 is the worst pain

Secondary outcomes

  1. Time to patient mobilization

    Time frame: First 24 hours post operative( 0 time is considered time to admission to post anesthesia care unit)

    Recording first time patient is able to mobilize without assistance

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 30, 2019
Registry last updated
Mar 3, 2020

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

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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.

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