Thoracic Paravertebral Block in Pain Management After Renal Surgery

NCT02840526 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2016-07-21

No results posted yet for this study

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.

Conditions

  • Postoperative Pain

Interventions

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)

Sponsors & Collaborators

  • Silesian University of Medicine

    lead OTHER

Principal Investigators

  • Hanna Misiolek, MD PhD · Medical School of Silesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02840526 on ClinicalTrials.gov