Morphine Versus Ketamine as Adjuvants in Paravertebral Blocks

NCT04852484 | Unknown

• 1 other identifier: 307/26-03-2021
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study will be to compare the effects of morphine versus ketamine when they are used as adjuvants to the local anesthetic in paravertebral nerve blocks performed with the aid of ultrasound. Furthermore, a group of local anesthetic without an adjuvant, will also be compared to the two groups

Conditions

Pain, Postoperative; Pain, Acute; Pain, Chronic; Pain, Neuropathic; Morphine; Ketamine; Analgesia

Outcome Measures

Primary Outcomes (1)

• morphine consumption in the first 48 hours

  patients will be followed for cumulative morphine consumption through patient-controlled analgesia device for 48 hours postoperatively

  48 hours postoperatively

Secondary Outcomes (16)

• morphine consumption in Post-Anesthesia Care Unit (PACU)

  24 hours postoperatively

• pain score on arrival to Post-Anesthesia Care Unit (PACU)

  immediately postoperatively

• pain score 6 hours postoperatively

  6 hours postoperatively

• pain score 12 hours postoperatively

  12 hours postoperatively

• pain score 24 hours postoperatively

  24 hours postoperatively

Study Arms (3)

local anesthetic and morphine group

ACTIVE COMPARATOR

paravertebral block with local anesthetic and morphine, followed by a continuous infusion of local anesthetic and morphine in the paravertebral space

Drug: local anesthetic-morphine

local anesthetic and ketamine group

ACTIVE COMPARATOR

paravertebral block with local anesthetic and ketamine, followed by a continuous infusion of local anesthetic and ketamine in the paravertebral space

Drug: local anesthetic-ketamine

local anesthetic group

ACTIVE COMPARATOR

paravertebral block with local anesthetic only, followed by a continuous infusion of local anesthetic only in the paravertebral space

Drug: local anesthetic

Interventions

local anesthetic-morphine DRUG

Before the operation, 19 mL of 0.5% Ropivacaine + 2 mg of morphine (20 mL in total) will be injected in the paravertebral space. Afterwards, there will be a pump of 500 ml of 0.2 % ropivacaine + 6 mg of morphine connected to the catheter after the end of the surgery, administered continuously at a rate of 10 mL/hr

Also known as: local anesthetic and morphine administered paravertebrally

local anesthetic and morphine group

local anesthetic-ketamine DRUG

Before the operation, 19 mL of 0.5% Ropivacaine + 50 mg of ketamine (20 mL in total) will be injected in the paravertebral space. Afterwards, there will be a pump of 500 ml of 0.2 % ropivacaine + 200 mg of ketamine connected to the catheter after the end of the surgery, administered continuously at a rate of 10 mL/hr

Also known as: local anesthetic and ketamine administered paravertebrally

local anesthetic and ketamine group

local anesthetic DRUG

Before the operation, 19 mL of 0.5% Ropivacaine + 1 mL of normal saline (20 mL in total) will be injected in the paravertebral space. Afterwards, there will be a pump of 500 ml of 0.2 % ropivacaine connected to the catheter after the end of the surgery, administered continuously at a rate of 10 mL/hr

Also known as: local anesthetic administered paravertebrally

local anesthetic group

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing elective thoracotomy for any cause
• American Society of Anesthesiologists class I-III (ASA I-III)

You may not qualify if:

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

Sponsors & Collaborators

• Aretaieion University Hospital: lead
• KAT General Hospital: collaborator

Study Sites (2)

Aretaieion University Hospital

Athens, 115 28, Greece

Location

KAT General Hospital of Athens

Athens, Greece

Location

Related Publications (7)

• Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007.

  PMID: 18456219 BACKGROUND

• D'Ercole F, Arora H, Kumar PA. Paravertebral Block for Thoracic Surgery. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):915-927. doi: 10.1053/j.jvca.2017.10.003. Epub 2017 Oct 4.

  PMID: 29169795 BACKGROUND

• El Mourad MB, Amer AF. Effects of adding dexamethasone or ketamine to bupivacaine for ultrasound-guided thoracic paravertebral block in patients undergoing modified radical mastectomy: A prospective randomized controlled study. Indian J Anaesth. 2018 Apr;62(4):285-291. doi: 10.4103/ija.IJA_791_17.

  PMID: 29720754 BACKGROUND

• Ahmed MJ, Ur Rehman A, Arshad RM, Amjad MWA, Khan Z, Furqan A. Efficacy of Dexmedetomidine vs Morphine as an Adjunct in a Paravertebral Block with Bupivacaine in Postoperative Analgesia Following Modified Radical Mastectomy. Cureus. 2020 May 22;12(5):e8231. doi: 10.7759/cureus.8231.

  PMID: 32582491 BACKGROUND

• Mao Y, Zuo Y, Mei B, Chen L, Liu X, Zhang Z, Gu E. Efficacy of perineural dexamethasone with ropivacaine in thoracic paravertebral block for postoperative analgesia in elective thoracotomy: a randomized, double-blind, placebo-controlled trial. J Pain Res. 2018 Sep 11;11:1811-1819. doi: 10.2147/JPR.S164225. eCollection 2018.

  PMID: 30254483 BACKGROUND

• Maruyama Y, Shimoji K, Shimizu H, Sato Y, Kuribayashi H, Kaieda R. Effects of morphine of human spinal cord and peripheral nervous activities. Pain. 1980 Feb;8(1):63-73. doi: 10.1016/0304-3959(80)90090-1.

  PMID: 7367037 BACKGROUND

• Kathirvel S, Sadhasivam S, Saxena A, Kannan TR, Ganjoo P. Effects of intrathecal ketamine added to bupivacaine for spinal anaesthesia. Anaesthesia. 2000 Sep;55(9):899-904. doi: 10.1046/j.1365-2044.2000.01472.x.

  PMID: 10947756 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain; Chronic Pain; Neuralgia; Agnosia

Interventions

Anesthetics, Local

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Perceptual Disorders; Neurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Kassiani Theodoraki, PhD, DESA

  Aretaieion University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 21, 2021
• Study Start: April 16, 2021
• Primary Completion: April 16, 2024
• Study Completion: April 16, 2024
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)