Clinical trial

Morphine Versus Ketamine as Adjuvants in Ultrasound-guided Paravertebral Thoracic Blocks in Elective Thoracic Surgery

Name

307/26-03-2021

Description

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

Trial arms

Trial start

2021-04-16

Estimated PCD

2024-04-16

Trial end

2024-04-16

Status

Active (not recruiting)

Treatment

local anesthetic-morphine

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

Arms:

local anesthetic and morphine group

Other names:

local anesthetic and morphine administered paravertebrally

local anesthetic-ketamine

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

Arms:

local anesthetic and ketamine group

Other names:

local anesthetic and ketamine administered paravertebrally

local anesthetic

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

Arms:

local anesthetic group

Other names:

local anesthetic administered paravertebrally

Size

Primary endpoint

morphine consumption in the first 48 hours

48 hours postoperatively

Eligibility criteria

Inclusion Criteria: * patients undergoing elective thoracotomy for any cause * American Society of Anesthesiologists class I-III (ASA I-III) Exclusion Criteria: * 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}

Updated at

2023-05-06

1 organization

2 products

1 drug

8 indications

Organization

Aretaieion University Hospital

Product

Local anesthetic-morphine

Indication

Pain