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Thoracic Paravertebral Block in Pain Management After Renal Surgery

Thoracic Paravertebral Block in Postoperative Pain Management After Renal Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02840526
Enrollment
58
Registered
2016-07-21
Start date
2013-05-31
Completion date
2014-12-31
Last updated
2016-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

PVB, PCA, nephrectomy, postoperative pain

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.

Interventions

PROCEDUREParavertebral blockade (PVB)

preoperative ThPVB performed unilaterally at Th10 level

DRUGSopodorm

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

DRUGPropofol WZF

propofol 2 mgkg-1intravenously (anesthesia induction)

DRUGNimbex

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

DRUGFentanyl WZF

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

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

DEVICEIntubation

Intratracheal intubation with a single lumen endotracheal tube

1 mgml-1 concentration oxycodone solution intravenously

DRUGParacetamol Kabi

1g paracetamol intravenously every 6 hours

DRUGKetonal

100 mg ketoprofen intravenously every 12 hours

DRUGBupivacaine WZF

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

Sponsors

Silesian University of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Difference in total amount of oxycodone needed in 48 hours after surgery48 hours postoperatively

Secondary

MeasureTime frame
Difference in prevalence of opioid related adverse events in OBAS scale24 hours, 48 hours after surgery
Difference in pain level in VAS scale48 hours postoperatively
Difference in level of sedation assessed in Ramsay scale48 hours after surgery
Difference in patient satisfaction level assessed in Likert scale48 hours after surgery

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026