Erector Spinae Plane Block vs Paravertebral Block for Pain Management in Fractured Ribs

NCT03883958 | Unknown

• 1 other identifier: ESPB vs. TPVB in Rib Fractures
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Rib fractures pose a significant healthcare burden with its associated morbidity, long term disability, and mortality. Pulmonary morbidity is increased in these patients as a result of diminished gas exchange from fracture induced pulmonary injury and from inadequate analgesia compromising both ventilation and pulmonary mechanics. Adequate analgesia is paramount in enhancing pulmonary hygiene aimed at preventing atelectasis and pneumonia. Numbing the nerves to the fractured ribs by injecting local anaesthetic (LA) improves breathing and reduces the risk of complications. Two techniques of regional anesthesia (erector spinae plane block (ESPB) and paravertebral block (PVB)) will be compared regarding their efficacy for treating pain caused by rib fractures. The LA is injected near nerves at two different locations. The PVB is immediately adjacent to the vertebrae, whereas the ESPB is slightly further away from the midline. Both techniques use ultrasound to ensure the LA is directed to the intended place. Adult patients with \> 3 consecutive fractured ribs will be consented, then randomised to receive either a ESPB or a PVB. It is expected that both groups will significantly improve in terms of pain score, opioids need, and breathing ability, however it is unclear which technique will provide better results and less complications.

Conditions

Rib Fracture Multiple

Outcome Measures

Primary Outcomes (2)

• Change in visual pain score

  0 meaning no pain at all, and 10 described as the worst pain experienced.

  Immediatly before and after intervention, 30 minutes after intervention, 3 hours after intervention, 6 hours after intervention and 24 hours after intervention

• Change in Diaphragmatic excursion

  Normal diaphragmatic excursion should be 3-5 cm, but can be increased in well-conditioned persons to 7-8 cm. This measures the contraction of the diaphragm. It is performed by asking the patient to exhale and hold it. The provider then percusses down their back in the intercostal margins (bone will be dull), starting below the scapula, until sounds change from resonant to dull (lungs are resonant, solid organs should be dull). That is where the provider marks the spot. Then the patient takes a deep breath in and holds it as the provider percusses down again, marking the spot where the sound changes from resonant to dull again. Then the provider will measure the distance between the two spots.

  Immediatly before and after intervention, 30 minutes after intervention, 3 hours after intervention, 6 hours after intervention and 24 hours after intervention.

Secondary Outcomes (1)

• Opioid dose used for 24-hour period after the procedure.

  24 hour after intervention

Study Arms (2)

TPVB

ACTIVE COMPARATOR

Procedure: Paravertebral Block

ESPB

EXPERIMENTAL

Procedure: Erector Spinae Plane Block

Interventions

Erector Spinae Plane Block PROCEDURE

ESPB will be performed in sitting or lateral decubitus position. The target vertebral level will be correspond to the approximate mid-point of the extent of fractured ribs. The tip of the transverse process of the target vertebra will be identified using the high-frequency linear placed in cephalocaudal orientation about 3 cm to the spinous process. The skin and subcutaneous tissue will be infiltrated with 2-3 ml of 2% lignocaine. With the transducer fixed over the targeted TP, a 22-gauge 88-mm needle (Spinocan, B. Braun, Germany) will be advanced in-plane to the ultrasound beam in a cephalo-caudal direction to contact the TP. Correct needle tip position will be confirmed by doing alternating aspiration to confirm lack of inadvertent vascular puncture with injection of 1-2 ml of saline and visualizing linear fluid spread deep to erector spinae muscle, separating it from the TP. A bolus dose (2ml/segment) of plain bupivacaine 0.5% plus 4mg of Dexamethasone will be injected.

ESPB

Paravertebral Block PROCEDURE

TPVB will be performed at a spinal level midway between the uppermost and the lowest fractured rib with the patient in sitting or lateral decubitus position (with patients lying on their unaffected side). The ultrasound-guided technique will be used. A high-frequency linear transducer will be used to confirm the levels of the fractured ribs. The most cephalad and most caudad fractured ribs will be identified first. The fractured rib in the middle will be then identified, and the rib will be then traced back medially. After skin and subcutaneous tissue infiltration with 2-3 ml of 2% lignocaine, a 22-gauge 88-mm needle (Spinocan, B. Braun, Germany) will be inserted in a lateral-to-medial direction until the needle tip entered the paravertebral space. 1-2 ml of Saline will be injected into the paravertebral space while observing the pleura being moved deeply. A bolus dose (2ml/segment) of plain bupivacaine 0.5% plus 4mg of Dexamethasone will be injected.

TPVB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients aged 18 years old or more.
• Rib Fracture Score 7 or more.
• American Society of Anesthesiologist's physiologic state II-III patients.
• consecutive fractured ribs.

You may not qualify if:

• Patients who are unable to communicate effectively.
• Sternal fractures.
• Bilateral rib fractures.
• VAS score \< 7.
• Preexisting spinal deformity.
• Local sepsis at site of injection.
• Coagulopathy.
• Known allergy to the local anesthetic used in the study.
• Patients having significant trauma outside the chest wall e.g., acute spine or pelvic fracture, severe traumatic brain or spinal cord injury, or abdominal visceral injuries.

Sponsors & Collaborators

• Assiut University: lead

Study Officials

• Mohamed Ahmed

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Ahmed

CONTACT

+201141987289; mohamed0youssefahmed91@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 21, 2019
• Study Start: December 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: March 21, 2019

Record last verified: 2019-03