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Clinical Trials/NCT02840526
NCT02840526
Completed
N/A

Thoracic Paravertebral Block in Postoperative Pain Management After Renal Surgery

Silesian University of Medicine1 site in 1 country58 target enrollmentMay 2013

Overview

Phase
N/A
Intervention
Paravertebral blockade (PVB)
Conditions
Postoperative Pain
Sponsor
Silesian University of Medicine
Enrollment
58
Locations
1
Primary Endpoint
Difference in total amount of oxycodone needed in 48 hours after surgery
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
December 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Silesian University of Medicine
Responsible Party
Principal Investigator
Principal Investigator

Maja Copik

M.D.

Silesian University of Medicine

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

PVB group

Thoracic paravertebral blockade PVB (preoperatively) Bupivacaine WZF Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi

Intervention: Paravertebral blockade (PVB)

PVB group

Thoracic paravertebral blockade PVB (preoperatively) Bupivacaine WZF Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi

Intervention: Sopodorm

PVB group

Thoracic paravertebral blockade PVB (preoperatively) Bupivacaine WZF Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi

Intervention: Propofol WZF

PVB group

Thoracic paravertebral blockade PVB (preoperatively) Bupivacaine WZF Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi

Intervention: Nimbex

PVB group

Thoracic paravertebral blockade PVB (preoperatively) Bupivacaine WZF Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi

Intervention: Fentanyl WZF

PVB group

Thoracic paravertebral blockade PVB (preoperatively) Bupivacaine WZF Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi

Intervention: Sevorane

PVB group

Thoracic paravertebral blockade PVB (preoperatively) Bupivacaine WZF Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi

Intervention: Intubation

PVB group

Thoracic paravertebral blockade PVB (preoperatively) Bupivacaine WZF Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi

Intervention: Oxynorm

PVB group

Thoracic paravertebral blockade PVB (preoperatively) Bupivacaine WZF Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi

Intervention: Paracetamol Kabi

PVB group

Thoracic paravertebral blockade PVB (preoperatively) Bupivacaine WZF Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi

Intervention: Ketonal

PVB group

Thoracic paravertebral blockade PVB (preoperatively) Bupivacaine WZF Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi

Intervention: Bupivacaine WZF

GEN group

Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi

Intervention: Sopodorm

GEN group

Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi

Intervention: Propofol WZF

GEN group

Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi

Intervention: Nimbex

GEN group

Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi

Intervention: Fentanyl WZF

GEN group

Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi

Intervention: Sevorane

GEN group

Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi

Intervention: Intubation

GEN group

Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi

Intervention: Oxynorm

GEN group

Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi

Intervention: Paracetamol Kabi

GEN group

Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi

Intervention: Ketonal

Outcomes

Primary Outcomes

Difference in total amount of oxycodone needed in 48 hours after surgery

Time Frame: 48 hours postoperatively

Secondary Outcomes

  • Difference in pain level in VAS scale(48 hours postoperatively)
  • Difference in prevalence of opioid related adverse events in OBAS scale(24 hours, 48 hours after surgery)
  • Difference in level of sedation assessed in Ramsay scale(48 hours after surgery)
  • Difference in patient satisfaction level assessed in Likert scale(48 hours after surgery)

Study Sites (1)

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