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

Tracking Information
First Submitted Date  ICMJE November 22, 2013
First Posted Date  ICMJE July 21, 2016
Last Update Posted Date July 21, 2016
Study Start Date  ICMJE May 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2016)
Difference in total amount of oxycodone needed in 48 hours after surgery [ Time Frame: 48 hours postoperatively ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2016)
  • Difference in prevalence of opioid related adverse events in OBAS scale [ Time Frame: 24 hours, 48 hours after surgery ]
  • Difference in pain level in VAS scale [ Time Frame: 48 hours postoperatively ]
  • Difference in level of sedation assessed in Ramsay scale [ Time Frame: 48 hours after surgery ]
  • Difference in patient satisfaction level assessed in Likert scale [ Time Frame: 48 hours after surgery ]
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 Thoracic Paravertebral Block in Pain Management After Renal Surgery
Official Title  ICMJE Thoracic Paravertebral Block in Postoperative Pain Management After Renal Surgery
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • Experimental: PVB group
    Thoracic paravertebral blockade PVB (preoperatively) Bupivacaine WZF Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi
    Interventions:
    • 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
  • GEN group
    Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi
    Interventions:
    • Drug: Sopodorm
    • Drug: Propofol WZF
    • Drug: Nimbex
    • Drug: Fentanyl WZF
    • Drug: Sevorane
    • Device: Intubation
    • Drug: Oxynorm
    • Drug: Paracetamol Kabi
    • Drug: Ketonal
Publications * Copik M, Bialka S, Daszkiewicz A, Misiolek H. Thoracic paravertebral block for postoperative pain management after renal surgery: A randomised controlled trial. Eur J Anaesthesiol. 2017 Sep;34(9):596-601. doi: 10.1097/EJA.0000000000000673.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2016)
58
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 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 Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02840526
Other Study ID Numbers  ICMJE SUM-PSK-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Maja Copik, Silesian University of Medicine
Study Sponsor  ICMJE Silesian University of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Hanna Misiolek, MD PhD Medical School of Silesia
PRS Account Silesian University of Medicine
Verification Date July 2016

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