Ultrasound-guided Deep Versus Superficial Continuous Serratus Anterior Plane Block for Pain Management in Patients With Multiple Rib Fractures

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04575272
Collaborator
(none)
62
2
23

Study Details

Study Description

Brief Summary

The present clinical study will be undertaken to evaluate the effect of Ultrasound-guided Deep versus Superficial continuous Serratus Anterior Plane Block for pain management in patients with multiple rib fractures.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Ultrasound-guided continuous serratus anterior plane block
N/A

Detailed Description

Thoracic blunt trauma, especially when multiple rib fractures are associated, is challenging to manage and causes significant morbidity due to the severe pain implied.

Patients can present with respiratory compromise as their capacity to expand the thorax is limited by pain. As a result, they are at high risk to develop atelectasis and pneumonia.

the key goal of management is adequate analgesia and pulmonary volume expansion Various strategies to treat such pain have been utilized, including regional analgesia (intrapleural, intercostal paravertebral nerve blockade), and neuraxial analgesia (thoracic epidural analgesia (TEA), intrathecal opioids).

The use of neuraxial analgesia in polytrauma is frequently limited by the need for aggressive venous thromboembolic (VTE) prophylaxis, and positioning of the patient for a neuraxial approach may be impossible.

There is a growing interest in exploring treatments that are less invasive than EA and can be performed on patients who have contraindications to neuraxial analgesia. Ultrasound-guided Serratus Anterior Plane (SAP) block is a recent technique, first described by Blanco et al. in 2013, that provides analgesia for the thoracic wall by blocking the lateral branches of the intercostal nerves from T2 to L2. It is a safe, simple to perform block with no significant contraindications or side effects. he described 2 potential spaces, one superficial and another deep to serratus. The SAPB has been used effectively for the management of pain in the context of rib fractures, thoracoscopic surgery, thoracotomy, breast surgery, and post-mastectomy pain syndrome, few studies compared the two approaches, and the difference between them has not yet been studied in patients with multiple rib fractures.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
neither the patient or the investigator included in data collection will be aware of the type of block performed or the group allocation
Primary Purpose:
Treatment
Official Title:
Ultrasound-guided Deep Versus Superficial Continuous Serratus Anterior Plane Block for Pain Management in Patients With Multiple Rib Fractures: Randomized Double-blind Clinical Trial
Anticipated Study Start Date :
Jan 10, 2021
Anticipated Primary Completion Date :
Oct 10, 2022
Anticipated Study Completion Date :
Dec 10, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Continuous Deep Serratus Anterior Plane Block group

at the level of the fifth rib in the mid-axillary line. After anaesthetizing the skin with 2 mL of lidocaine 2%, an 18-gauge Touhy needle was introduced in-plane, under direct visualization, to the plane immediately deep to the serratus anterior muscle. After negative aspiration, 35 mL of bupivacaine 0.25% will be injected. Afterwards, a 20-gauge peripheral nerve catheter will be threaded into the space. then bupivacaine 0.125% infusion at a rate of 5 ml/h by an Infusion Syringe Pump will be started.

Procedure: Ultrasound-guided continuous serratus anterior plane block
Local anesthetic infusion though a peripheral nerve catheter placed related to the serratus anterior muscle at the level of the 5th rib

Active Comparator: Continuous Superficial Serratus Anterior Plane Block group

at the level of the fifth rib in the mid-axillary line. After anaesthetizing the skin with 2 mL of lidocaine 2%, an 18-gauge Touhy needle was introduced in-plane, under direct visualization, to the plane immediately superficial to the serratus anterior muscle. After negative aspiration, 35 mL of bupivacaine 0.25% will be injected. Afterwards, a 20-gauge peripheral nerve catheter will be threaded into the space. then bupivacaine 0.125% infusion at a rate of 5 ml/h by an Infusion Syringe Pump will be started.

Procedure: Ultrasound-guided continuous serratus anterior plane block
Local anesthetic infusion though a peripheral nerve catheter placed related to the serratus anterior muscle at the level of the 5th rib

Outcome Measures

Primary Outcome Measures

  1. Change in pain score [before and after the block at "30 minutes", "2hours", "4hours", "6hours", "12hours", "24hours", "36hours", "48 hours" & "72hours"]

    patient report numerical rating scale (NRS) 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable"

Secondary Outcome Measures

  1. Change in inspiratory volumes (mL) [before and after block at "90 minutes" then every "12hours" for 3 days]

    Maximum inspiratory respiratory volume (measured in ml) recorded on single use of incentive spirometer device

  2. The time of the first rescue analgesic and the total analgesic consuption [day 0, day 1, day 2, day 3]

    when NRS is over 4, 30 mg of i.v ketorlac will be given and its time will be recorded the total dose through 24 hr will be recorded for 3 days

  3. change in Serum beta-endorphin level [before procedure and at 24 hours post procedure]

    We will use radioimmunoassays to measure plasma beta-endorphin level

  4. Lung Ultrasound Score (LUSS) [before and after block at "90 minutes" then every "24 hours" for 3 days]

    We will use a techniques based on the international evidence-based recommendations for point-of-care lung ultrasound that recommended using a complete eight-zone lung ultrasound ,The worst ultrasound pattern observed in each zone was recorded and used to calculate the sum of the scores (total score = 24).

  5. hospital stay [day for discharge, assessed up to 14 days]

    time to fill the discharge criteria

  6. mean arterial blood pressure [before and after the block every "2hours" for 3 days]

    mean arterial blood pressure by non invaisive blood pressure monitoring

  7. heart rate [before and after the block every "2hours" for 3 days]

    heart rate by EKG monitor

  8. peripheral arterial oxygen saturation (SpO2) [before and after the block every "2hours" for 3 days]

    measured by Pulse oximetry

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adult patients of either sex, having three or more unilateral fracture ribs and admitted to the trauma ICU, Rib fractures were confirmed by X-ray and CT scan reads.
Exclusion Criteria:
  • significant head injury and unconsciousness (GCS less than 14)

  • Patients with significant pain from other injuries

  • pathological obesity (body mass index ≥35)

  • history of drug allergy local anesthetics

  • local infection at the injection site

  • inability to obtain consent from patient or surrogate, and patient refusal

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mohammed mamdouh mohammed mahmoud, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT04575272
Other Study ID Numbers:
  • Serratus Plane Block and MFRs
First Posted:
Oct 5, 2020
Last Update Posted:
Dec 10, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mohammed mamdouh mohammed mahmoud, Principal Investigator, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 10, 2020