Ultrasound- Guided Continuous Serratus Anterior Plane Block Versus Ultrasound- Guided Continuous Thoracic Paravertebral Block in Multiple Traumatic Rib Fractures.

Sponsor
Tanta University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04710823
Collaborator
(none)
70
1
2
3.4
20.5

Study Details

Study Description

Brief Summary

The aim of this study is to compare the analgesic efficacy of ultrasound guided continuous SAP block and ultrasound guided continuous TPVB in patients with multiple traumatic rib fractures.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Thoracic paravertebral block
  • Procedure: Serratus anterior plane block
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Ultrasound- Guided Continuous Serratus Anterior Plane Block Versus Ultrasound- Guided Continuous Thoracic Paravertebral Block For Analgesia in Multiple Traumatic Rib Fractures.
Actual Study Start Date :
Jan 16, 2021
Anticipated Primary Completion Date :
Apr 25, 2021
Anticipated Study Completion Date :
Apr 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Thoracic paravertebral block

Patients will receive ultrasound-guided continuous thoracic paravertebral blockusing bupivacaine 0.25% for 4 days.

Procedure: Thoracic paravertebral block
A bolus dose of 0.25% bupivacaine (0.3 ml/kg) will be injected slowly over 3-5 minutes. At 30 minutes after injection of the loading dose, the dermatomal loss of sensation to pinprick was tested. Patients who reported pain to pinprick will be considered to have a failed block and were excluded from the study. The block will be maintained by continuous infusion of bupivacaine 0.25% at a rate of 0.1 ml/kg/h via a syringe pump. The infusion will be continued for 4 days.

Experimental: Serratus anterior plane block

Patients will receive ultrasound-guided continuous SAP block using bupivacaine 0.25% for 4 days.

Procedure: Serratus anterior plane block
A bolus of 30 ml of 0.25% bupivacaine will be injected slowly over 3-5 minutes between latissmus dorsi muscle and serratus anterior muscle (Figure 15). Then a catheter was inserted through the Tuohy needle and advanced 3cm into the space and secured in place. At 30 minutes after injection of a loading dose, the dermatomal loss of sensation to pinprick will be tested. Patients who reported pain to pinprick will be considered to have a failed block and were excluded from the study. The block will be maintained by continuous infusion of bupivacaine 0.25% at a rate of 0.1 ml/kg/h via a syringe pump. The infusion was continued for 4 days.

Outcome Measures

Primary Outcome Measures

  1. Degree of pain scores [Four days after the block]

    Pain will be assessed at rest and on coughing using the VAS on a scale from 0 (no pain) to 100 (worst pain) before the block, 30 minutes, 60 minutes after the block, and then every six hours for 4 days. But in order not to interrupt the sleeping pattern of patients, patients will be considered pain free (VAS= 0) if they will be at sleep with no tachypnea, tachycardia, or hypertension.

Secondary Outcome Measures

  1. Total consumption of morphine [Four days after the block]

    Rescue analgesia will be provided with morphine (0.05 mg/kg) intravenously if visual analogue score (VAS) ≥ 40.

  2. Changes of forced vital capacity (FVC) [Four days after the block]

    Forced vital capacity (FVC) will be assessed using bedside spirometry before the block, 30 minutes, 60 minutes after the blocks, and then every eight hours for 4 days

  3. Changes of forced expiratory volume in one second (FEV1) [Four days after the block]

    Forced expiratory volume in one second (FEV1) will be assessed using bedside spirometry before the block, 30 minutes, 60 minutes after the blocks, and then every eight hours for 4 days

  4. Changes of forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) [Four days after the block]

    FEV1/FVC ratio will be assessed using bedside spirometry before the block, 30 minutes, 60 minutes after the blocks, and then every eight hours for 4 days

  5. Length of ICU stay [Four days after the block]

    Length of ICU stay, defined as the time from admission to ICU to time of transfer to the surgical ward.

  6. Length of hospital stay [Four days after the block]

  7. Incidence of complications [Four days after the block]

    Incidence of respiratory complications and mechanical ventilation

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients of either gender aged between 22-65 years with unilateral traumatic multiple fracture ribs (≥ 3 fractured ribs).
Exclusion Criteria:
  • • Contraindications to regional block such as patient's refusal, coagulopathy, local infection at the site of the block, known allergy to local anesthetic drugs and spinal deformity.

  • Patients suffer from severe cardiovascular disease, hepatic or renal disease and patients with history of psychiatric illness.

  • Patients had indications for mechanical ventilation on admission or during the study period.

  • Patients had indications for immediate surgery for other associated injuries.

  • Patients with hemodynamic instability.

  • Patients having spine or pelvic fracture, traumatic brain injury, altered conscious level or spinal cord injury.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tanta University Hospitals Tanta ElGharbiaa Egypt 31527

Sponsors and Collaborators

  • Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Osama Rehab, Principal Investigator; Assistant lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Tanta University
ClinicalTrials.gov Identifier:
NCT04710823
Other Study ID Numbers:
  • 32596/09/18
First Posted:
Jan 15, 2021
Last Update Posted:
Jan 20, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 20, 2021