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Completed

NCT Number: NCT02840526

Thoracic Paravertebral Block in Pain Management After Renal Surgery

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samodzielny Publiczny Szpital Kliniczny nr 1 SUM Zabrze

Zabrze, Silesian Voivodeship, 41-800, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paravertebral blockade (PVB)

Procedure

preoperative ThPVB performed unilaterally at Th10 level

Sopodorm

Drug

midazolam 0,1 mgkg-1 intravenously (anesthesia induction)

Propofol WZF

Drug

propofol 2 mgkg-1intravenously (anesthesia induction)

Nimbex

Drug

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

Fentanyl WZF

Drug

fentanyl 1,5 µgkg-1 intravenously (anesthesia induction)

sevorane

Drug

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

Intubation

Device

Intratracheal intubation with a single lumen endotracheal tube

OxyNorm

Drug

1 mgml-1 concentration oxycodone solution intravenously

Paracetamol Kabi

Drug

1g paracetamol intravenously every 6 hours

Ketonal

Drug

100 mg ketoprofen intravenously every 12 hours

Bupivacaine WZF

Drug

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

Primary outcomes

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

    Time frame: 48 hours postoperatively

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Silesian University of Medicine

Other

Registry information

Official study title

Thoracic Paravertebral Block in Postoperative Pain Management After Renal Surgery

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 21, 2016
Registry last updated
Jul 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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