Clinical trial NCT05843344: Dexmedetomidine and Morphine as Adjuvants to US Guided Erector Spinae Plane Blocks in Elective Thoracic Surgeries
Official title: Dexmedetomidine and Morphine as Adjuvants to US Guided Erector Spinae Plane Blocks in Elective Thoracic Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Pain, Acute
Pain, Chronic
Morphine
Dexmedetomidine
Analgesia
Lead sponsor: Aretaieion University Hospital
Sponsor class: OTHER
Collaborators: name: Sotiria General Hospital
First posted: 2023-05-06
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intravenous morphine consumption in the first 48 hours post-operatively
timeFrame: 48 hours post-operatively
Secondary outcomes:
measure: IV morphine consumption in the first 6 hours
timeFrame: 6 hours post-operatively
measure: IV morphine consumption in the first 12 hours
timeFrame: 12 hours post-operatively
measure: IV morphine consumption in the first 24 hours
timeFrame: 24 hours post-operatively
measure: Intraoperative remifentanil consumption
timeFrame: Duration of operation
measure: Intraoperative morphine consumption
timeFrame: Duration of operation
measure: Pain score after surgery (PACU)
timeFrame: immediately post-operatively
measure: Pain score 6 hours post-operatively
timeFrame: 6 hours post-operatively
measure: Pain score 12 hours post-operatively
timeFrame: 12 hours post-operatively
measure: Pain score 24 hours post-operatively
timeFrame: 24 hours post-operatively
measure: Pain score 48 hours post-operatively
timeFrame: 48 hours post-operatively
measure: side effects post-operatively
timeFrame: 48 hours post-operatively
measure: satisfaction from post-operative analgesia
timeFrame: 48 hours post-operatively
measure: time to first request of analgesia
timeFrame: 48 hours post-operatively
measure: Patient agitation- sedation status post-operatively (PACU)
timeFrame: Immediately post-operatively
measure: Patient agitation- sedation status in the first 6 hours
timeFrame: 6 hours post-operatively
measure: Patient agitation- sedation status in the first 12 hours
timeFrame: 12 hours post-operatively
measure: Patient agitation- sedation status in the first 24 hours
timeFrame: 24 hours post-operatively
measure: Patient agitation- sedation status in the first 48 hours
timeFrame: 48 hours post-operatively
measure: Nausea and vomiting
timeFrame: 24 hours post-operatively
measure: Chronic pain 3 months after operation
timeFrame: 3 months post-operatively
measure: Chronic pain 6 months after operation
timeFrame: 6 months post-operatively
measure: Post-operative cognitive disorder (POCD)
timeFrame: 48hours post-operatively
measure: Post-operative Delirium (POD) Incidence
timeFrame: 48 hours post-operatively
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Sotiria Thoracic Diseases Hospital
city: Athens
country: Greece
facility: Aretaieion University Hospital
Study officials:
affiliation: Aretaieion UNiversity Hospital, National and Kapodistrin University of Athens, Greece
name: Kassiani Theodoraki, PhD, DESA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007.
citation: A Mesbah, MB BCh FCAI FRCA, J Yeung, MB ChB FRCA PhD FFICM, F Gao, MB BS PhD MPhil FRCA MD FFICM, Pain after thoracotomy, BJA Education, Volume 16, Issue 1, January 2016, Pages 1-7, https://doi.org/10.1093/bjaceaccp/mkv005
citation: Mazo V, Sabate S, Canet J, Gallart L, de Abreu MG, Belda J, Langeron O, Hoeft A, Pelosi P. Prospective external validation of a predictive score for postoperative pulmonary complications. Anesthesiology. 2014 Aug;121(2):219-31. doi: 10.1097/ALN.0000000000000334.
citation: Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.
citation: Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
citation: Kot P, Rodriguez P, Granell M, Cano B, Rovira L, Morales J, Broseta A, Andres J. The erector spinae plane block: a narrative review. Korean J Anesthesiol. 2019 Jun;72(3):209-220. doi: 10.4097/kja.d.19.00012. Epub 2019 Mar 19.
citation: Hassan ME, Wadod MAA. Serratus anterior plane block and erector spinae plane block in postoperative analgesia in thoracotomy: A randomised controlled study. Indian J Anaesth. 2022 Feb;66(2):119-125. doi: 10.4103/ija.ija_257_21. Epub 2022 Feb 24.
citation: Hamed MA, Fargaly OS, Abdelghaffar RA, Moussa MA, Algyar MF. The role of dexmedetomidine as an adjuvant for high-thoracic erector spinae plane block for analgesia in shoulder arthroscopy; a randomized controlled study. BMC Anesthesiol. 2023 Feb 15;23(1):53. doi: 10.1186/s12871-023-02014-2.
citation: Gao Z, Xiao Y, Wang Q, Li Y. Comparison of dexmedetomidine and dexamethasone as adjuvant for ropivacaine in ultrasound-guided erector spinae plane block for video-assisted thoracoscopic lobectomy surgery: a randomized, double-blind, placebo-controlled trial. Ann Transl Med. 2019 Nov;7(22):668. doi: 10.21037/atm.2019.10.74.
citation: Ling L, Yang TX, Lee SWK. Effect of Anaesthesia Depth on Postoperative Delirium and Postoperative Cognitive Dysfunction in High-Risk Patients: A Systematic Review and Meta-Analysis. Cureus. 2022 Oct 10;14(10):e30120. doi: 10.7759/cureus.30120. eCollection 2022 Oct.
citation: Suraarunsumrit P, Pathonsmith C, Srinonprasert V, Sangarunakul N, Jiraphorncharas C, Siriussawakul A. Postoperative cognitive dysfunction in older surgical patients associated with increased healthcare utilization: a prospective study from an upper-middle-income country. BMC Geriatr. 2022 Mar 16;22(1):213. doi: 10.1186/s12877-022-02873-3.