Dexmedetomidine and Morphine as Adjuvants to US Guided Erector Spinae Plane Blocks in Elective Thoracic Surgeries

Dr Kassiani Theodoraki

Status: Not yet enrolling

Conditions: Morphine; Dexmedetomidine; Pain, Acute; Pain, Postoperative; Pain, Chronic; Analgesia

Treatments: Drug: erector spinae plane block with a combination of ropivacaine and morphine; Drug: erector spinae plane block with a combination of ropivacaine and dexmedetomidine; Drug: erector spinae plane block with ropivacaine only

Study type: Interventional

Funder types: Other

Identifiers

NCT05843344

492/15-03-2023

Details and patient eligibility

About

The aim of this study will be to compare the effects of morphine versus dexmedetomidine when used as adjuvants to local anesthetic (Ropivacaine) in Erector Spinae Plane Block under ultrasound guidance. A group without an adjuvant will also be compared to the groups.

Full description

Erector Spinae Plane Block (ESPB) was first introduced in 2016 as a treatment technique for chronic thoracic neuropathic pain, and rapidly became popular in peri-operative medicine due to its relatively simple technique and low complication rate. It has been also used extensively in thoracic surgery. According to a systematic review, ESPB can be used effectively as part of multimodal analgesia in thoracic surgery since, when used, opioid consumption decreases.

The use of adjuvants has been studied to a limited extent in ESPB. Dexmedetomidine and dexamethasone have been tried as adjuvants in ESPB and it has been shown that dexmedetomidine is more effective in block prolongation and post-operative opioid consumption. According to our knowledge, morphine has not been used yet as an adjuvant for ESPB.

Therefore, the investigators will perform a randomized controlled trial in order to compare morphine and dexmedetomidine as adjuvants in ESPB in elective thoracotomies in terms of intraoperative and post-operative opioid consumption. Intraoperative opioid consumption will be guided by vital signs and Nociception-Level Index (NOL) and post-operative opioid consumption will be measured by the amount of morphine consumed by the patient during the first 48 hours post-operatively. Secondary outcomes will also be recorded.

Enrollment: 90 estimated patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients undergoing elective thoracotomy for any cause (ASA I-III)

Exclusion criteria

• known allergy to local anesthetic
• local inflammation
• severe respiratory distress ( breathing dependence on accessory muscles)
• severe spinal deformities
• severe ipsilateral diaphragmatic paresis
• morbid obesity (BMI>35 kg/m2)
• blood coagulation disorder
• known contraindication for administration of dexmedetomidine or morphine
• severe cardiovascular disease
• systematic use of opioids due to chronic pain
• renal or hepatic failure
• patients who refuse to participate.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups

ropivacaine and morphine group

Active Comparator group

Description:

erector spinae plane block with a combination of ropivacaine and morphine

Treatment:

Drug: erector spinae plane block with a combination of ropivacaine and morphine

ropivacaine and dexmedetomidine group

Active Comparator group

Description:

erector spinae plane block with a combination of ropivacaine and dexmedetomidine

Treatment:

Drug: erector spinae plane block with a combination of ropivacaine and dexmedetomidine

ropivacaine group

Active Comparator group

Description:

erector spinae plane block with ropivacaine only

Treatment:

Drug: erector spinae plane block with ropivacaine only