Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Thoracic Paravertebral Block in Pain Management After Renal Surgery

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: NCT02840526
Recruitment Status : Completed
First Posted : July 21, 2016
Last Update Posted : July 21, 2016
Sponsor:
Information provided by (Responsible Party):
Maja Copik, Silesian University of Medicine

Brief Summary:

Objective: The objective of the study was to assess the usefulness of ThPVB in postoperative pain management after open renal resection surgery.

Design, setting, participants: It was a prospective, randomised, open label study held in a university hospital between 08.2013-12.2014. 58 Patients enrolled in the study were scheduled for elective open renal surgery (open nephrectomy or open nephron-sparing surgery) and randomised into two groups - group PVB (n=27) and group GEN (n=31).

Interventions: PVB group received preoperative ThPVB with 0,5% bupivacaine followed by general anaesthesia. GEN group received standard general anaesthesia. Both groups were treated postoperatively with oxycodone IV PCA (patient controlled analgesia) combined with non-opioid analgesics as rescue drugs. The investigators recorded pain severity in VAS, oxycodone requirement in time points, total oxycodone requirement, and sedation levels throughout the first 48h. The investigators measured opioid related adverse events 24 and 48 h postoperatively and patients satisfaction 48h postoperatively.


Condition or disease Intervention/treatment Phase
Postoperative Pain Procedure: Paravertebral blockade (PVB) Drug: Sopodorm Drug: Propofol WZF Drug: Nimbex Drug: Fentanyl WZF Drug: Sevorane Device: Intubation Drug: Oxynorm Drug: Paracetamol Kabi Drug: Ketonal Drug: Bupivacaine WZF Not Applicable

Detailed Description:

In PVB group before the induction of general anaesthesia a single shot thoracic paravertebral blockade was performed. ThPVB was performed on Th7-Th10 level, approximately 2,5 - 3 cm lateral from the top of the spinous process with prior ultrasound control of the depth of the transverse process and the pleura. To make the procedure safer the investigators used peripheral nerve stimulation with an isolated 10 cm needle with a start current of 2,5 mA. The needle was inserted until visible muscle activity from intercostal muscles appeared, with a current of 0,5-0,3mA (paravertebral space identification). Next 0,3 ml kg-1 0,5% plain bupivacaine was injected after negative aspiration for air and blood. The efficacy of the blockade was checked after 20 minutes with cold saline.

In both groups, PVB and GEN general anaesthesia was induced with midazolam 0,1 mgkg-1, propofol 2 mgkg-1, cis-atracurium 0,15 mgkg-1 and fentanyl 1,5 µgkg-1. Patients were intubated with a standard single lumen tracheal tube. Anaesthesia was maintained with 1 MAC (Minimal Alveolar Concentration) sevoflurane. For surgical analgesia the investigators used fractional doses of fentanyl 1-3 mg kg-1 if HR (heart rate) or MBP (mean blood pressure) raised above 20% of basal values. Waking up from anaesthesia was in a post-anaesthesia care unit.

Postoperative pain management schedule was identical in both groups. After the surgery, if pain appeared, the patient was given oxycodone i.v. titrated to achieve acceptable analgesia level or until side effects appeared. Every patient received a PCA (Patient controlled analgesia) device with a 1 mgml-1 concentration oxycodone solution with a programmed single bolus dose of 1 mg and a lockout time of 5 minutes. Additionally, patients were given 1g i.v. paracetamol every 6 hours and 100 mg of i.v. ketoprofen every 12 hours.

For 48 h postoperatively, the investigators monitored HR, SBP (systolic blood pressure) , DBP (diastolic blood pressure), sedation level in Ramsay scale, pain intensity at rest in VAS (visual analogue score) scale, oxycodone requirement in pre-selected time points and total oxycodone requirement. The investigators also recorded opioid-related adverse events 24 and 48 h postoperatively in OBAS scale and patients' satisfaction regarding postoperative analgesia 48 h postoperatively in Likert scale.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Thoracic Paravertebral Block in Postoperative Pain Management After Renal Surgery
Study Start Date : May 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PVB group
Thoracic paravertebral blockade PVB (preoperatively) Bupivacaine WZF Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi
Procedure: Paravertebral blockade (PVB)
preoperative ThPVB performed unilaterally at Th10 level

Drug: Sopodorm
midazolam 0,1 mgkg-1 intravenously (anesthesia induction)

Drug: Propofol WZF
propofol 2 mgkg-1intravenously (anesthesia induction)

Drug: Nimbex
cis-atracurium 0,15 mgkg-1 intravenously (anesthesia induction)

Drug: Fentanyl WZF
fentanyl 1,5 µgkg-1 intravenously (anesthesia induction)

Drug: Sevorane
sevoflurane in 1 MAC (Minimal Alveolar Concentration) - anesthesia maintenance

Device: Intubation
Intratracheal intubation with a single lumen endotracheal tube

Drug: Oxynorm
1 mgml-1 concentration oxycodone solution intravenously

Drug: Paracetamol Kabi
1g paracetamol intravenously every 6 hours

Drug: Ketonal
100 mg ketoprofen intravenously every 12 hours

Drug: Bupivacaine WZF
0,3 ml kg-1 0,5% plain bupivacaine (regional anesthesia - paravertebral blockade)

GEN group
Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi
Drug: Sopodorm
midazolam 0,1 mgkg-1 intravenously (anesthesia induction)

Drug: Propofol WZF
propofol 2 mgkg-1intravenously (anesthesia induction)

Drug: Nimbex
cis-atracurium 0,15 mgkg-1 intravenously (anesthesia induction)

Drug: Fentanyl WZF
fentanyl 1,5 µgkg-1 intravenously (anesthesia induction)

Drug: Sevorane
sevoflurane in 1 MAC (Minimal Alveolar Concentration) - anesthesia maintenance

Device: Intubation
Intratracheal intubation with a single lumen endotracheal tube

Drug: Oxynorm
1 mgml-1 concentration oxycodone solution intravenously

Drug: Paracetamol Kabi
1g paracetamol intravenously every 6 hours

Drug: Ketonal
100 mg ketoprofen intravenously every 12 hours




Primary Outcome Measures :
  1. Difference in total amount of oxycodone needed in 48 hours after surgery [ Time Frame: 48 hours postoperatively ]

Secondary Outcome Measures :
  1. Difference in prevalence of opioid related adverse events in OBAS scale [ Time Frame: 24 hours, 48 hours after surgery ]
  2. Difference in pain level in VAS scale [ Time Frame: 48 hours postoperatively ]
  3. Difference in level of sedation assessed in Ramsay scale [ Time Frame: 48 hours after surgery ]
  4. Difference in patient satisfaction level assessed in Likert scale [ Time Frame: 48 hours after surgery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Age 18-75
  • Scheduled for elective open nephrectomy or NSS
  • Gave written consent
  • BMI 19-30
  • ASA status I-III

Exclusion criteria:

  • Presence of chronic pain
  • Chronic mental conditions (depression)
  • Contraindications for PVB
  • Chest or spine deformations
  • Infection in planned site of PVB
  • Allergies for drugs used in the study
  • Cancer invading chest wall

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840526


Locations
Layout table for location information
Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 SUM Zabrze
Zabrze, Slaskie, Poland, 41-800
Sponsors and Collaborators
Silesian University of Medicine
Investigators
Layout table for investigator information
Study Chair: Hanna Misiolek, MD PhD Medical School of Silesia
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Maja Copik, M.D., Silesian University of Medicine
ClinicalTrials.gov Identifier: NCT02840526    
Other Study ID Numbers: SUM-PSK-1
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: July 21, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Maja Copik, Silesian University of Medicine:
PVB
PCA
nephrectomy
postoperative pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Acetaminophen
Fentanyl
Bupivacaine
Propofol
Sevoflurane
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Analgesics, Non-Narcotic
Antipyretics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation