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Morphine Versus Ketamine as Adjuvants in Paravertebral Blocks (Annie-Dimitr)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04852484
Recruitment Status : Active, not recruiting
First Posted : April 21, 2021
Last Update Posted : April 22, 2021
Sponsor:
Collaborator:
KAT General Hospital
Information provided by (Responsible Party):
Dr Kassiani Theodoraki, Aretaieion University Hospital

Tracking Information
First Submitted Date  ICMJE April 16, 2021
First Posted Date  ICMJE April 21, 2021
Last Update Posted Date April 22, 2021
Actual Study Start Date  ICMJE April 16, 2021
Estimated Primary Completion Date April 16, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2021)
morphine consumption in the first 48 hours [ Time Frame: 48 hours postoperatively ]
patients will be followed for cumulative morphine consumption through patient-controlled analgesia device for 48 hours postoperatively
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2021)
  • morphine consumption in Post-Anesthesia Care Unit (PACU) [ Time Frame: 24 hours postoperatively ]
    mg of morphine requested during patient PACU stay
  • pain score on arrival to Post-Anesthesia Care Unit (PACU) [ Time Frame: immediately postoperatively ]
    pain score by the use of Numeric Rating Scale (NRS) on arrival to PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
  • pain score 6 hours postoperatively [ Time Frame: 6 hours postoperatively ]
    pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
  • pain score 12 hours postoperatively [ Time Frame: 12 hours postoperatively ]
    pain score by the use of Numeric Rating Scale (NRS) 12 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
  • pain score 24 hours postoperatively [ Time Frame: 24 hours postoperatively ]
    pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
  • pain score 48 hours postoperatively [ Time Frame: 48 hours postoperatively ]
    pain score by the use of Numeric Rating Scale (NRS) 48 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
  • morphine consumption in the first 6 hours [ Time Frame: 6 hours postoperatively ]
    patients will be followed for cumulative morphine consumption through patient-controlled analgesia device for 6 hours postoperatively
  • morphine consumption in the first 12 hours [ Time Frame: 12 hours postoperatively ]
    patients will be followed for cumulative morphine consumption through patient-controlled analgesia device for 12 hours postoperatively
  • morphine consumption in the first 24 hours [ Time Frame: 24 hours postoperatively ]
    patients will be followed for cumulative morphine consumption through patient-controlled analgesia device for 24 hours postoperatively
  • side effects postoperatively [ Time Frame: 96 hours postoperatively ]
    patients will be monitored for side-effects of the administered agents postoperatively
  • satisfaction from postoperative analgesia [ Time Frame: 48 hours postoperatively ]
    satisfaction from postoperative analgesia on a four-point Likert scale with 1 marked as minimal satisfaction and 4 as maximal satisfaction
  • morphine requirement during surgery [ Time Frame: intraoperatively ]
    dose of required morphine administered intraoperatively
  • time to first request for analgesia [ Time Frame: during stay in Post-Anesthesia Care Unit, 24 hours postoperatively ]
    the time for the first patient request for analgesia will be noted
  • hospitalization time [ Time Frame: 7 days postoperatively ]
    duration of hospital stay after surgery in days
  • incidence of chronic pain 3 months after surgery [ Time Frame: 3 months after surgery ]
    occurrence of chronic pain at the site of the operation 3 months after surgery, with the use of the Numeric Rating Scale (NRS), at rest and during movement
  • incidence of chronic pain 6 months after surgery [ Time Frame: 6 months after surgery ]
    occurrence of chronic pain at the site of the operation 6 months after surgery, with the use of the Numeric Rating Scale (NRS), at rest and during movement
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Morphine Versus Ketamine as Adjuvants in Paravertebral Blocks
Official Title  ICMJE Morphine Versus Ketamine as Adjuvants in Ultrasound-guided Paravertebral Thoracic Blocks in Elective Thoracic Surgery
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
Detailed Description

Elective thoracotomies are usually performed for removal of pathological masses in the mediastinum, lung parenchyma and upper gastrointestinal system. They are considered to be painful operations, related to both acute and chronic pain (post- thoracotomy pain syndrome), the latter lasting for a minimum period of 2 months.

Post-operative thoracic pain is associated often with diaphragmatic dysfunction, which can also lead to atelectasis and pneumonia and post-operative pulmonary complications in general.

Several techniques have been tried in order to minimize such events. Thoracic epidural analgesia, intravenous analgesia, intercostal blocks, local infiltration of local anesthetics by the surgeon are some of them.

Paravertebral thoracic blocks have become increasingly popular in recent years since they are less likely to cause neurologic complications than thoracic epidural analgesia. Moreover, bleeding disorders, and use of anti-coagulant and anti- thrombotic medications, which are considered as contraindications to an epidural procedure, are not strict contraindications in the performance of paravertebral blocks, especially when they are performed under ultrasonographic guidance.

Ropivacaine and Levobupivacaine are the most popular local anesthetics that have been used. Moreover, several adjuvants have been added to them in order to enhance the effects of those blocks. Dexamethasone, Morphine, Dexmedetomidine, Clonidine, Ketamine, Magnesium Sulphate are some of them. Results are variable.

The rationale behind adjuvants used to enhance effects of local anesthetics is the fact that some seem to act directly in the spinal cord receptors and the central nervous system. The effect of morphine on the dorsal horns of the spinal cord has been extensively studied in the past. Due to its limited lipophilicity, it is assumed that administering the specific drug to the paravertebral space could lead to its transfer and action on the dorsal horns.

On the other hand, the action of ketamine seems to be by blocking N-Methyl-D-Aspartate (NMDA) receptors in the spinal cord. It is also considered to have an effect on voltage sensitive Ca2+ channels, opioid receptors, and monoaminergic receptors. Therefore, it is considered overall to affect nociception.

Overall, it is assumed that morphine might have an effect on the dorsal horns of the spinal cord, and ketamine on NMDA receptors at "higher pain centers". It is also assumed that there will be some degree of systemic absorption due to the rich vascular supply of the specific area. The investigators aim to compare the effects of those two 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Pain, Postoperative
  • Pain, Acute
  • Pain, Chronic
  • Pain, Neuropathic
  • Morphine
  • Ketamine
  • Analgesia
Intervention  ICMJE
  • Drug: 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
    Other Name: local anesthetic and morphine administered paravertebrally
  • Drug: 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
    Other Name: local anesthetic and ketamine administered paravertebrally
  • Drug: 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
    Other Name: local anesthetic administered paravertebrally
Study Arms  ICMJE
  • Active Comparator: local anesthetic and morphine group
    paravertebral block with local anesthetic and morphine, followed by a continuous infusion of local anesthetic and morphine in the paravertebral space
    Intervention: Drug: local anesthetic-morphine
  • Active Comparator: local anesthetic and ketamine group
    paravertebral block with local anesthetic and ketamine, followed by a continuous infusion of local anesthetic and ketamine in the paravertebral space
    Intervention: Drug: local anesthetic-ketamine
  • Active Comparator: local anesthetic group
    paravertebral block with local anesthetic only, followed by a continuous infusion of local anesthetic only in the paravertebral space
    Intervention: Drug: local anesthetic
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 16, 2021)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 16, 2023
Estimated Primary Completion Date April 16, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04852484
Other Study ID Numbers  ICMJE 307/26-03-2021
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr Kassiani Theodoraki, Aretaieion University Hospital
Study Sponsor  ICMJE Aretaieion University Hospital
Collaborators  ICMJE KAT General Hospital
Investigators  ICMJE
Principal Investigator: Kassiani Theodoraki, PhD, DESA Aretaieion University Hospital
PRS Account Aretaieion University Hospital
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP