Thoracic Paravertebral Blocks in Open Nephrectomy

Asklepieion Voulas General Hospital

Status and phase: Completed; Phase 2

Conditions: Nephrectomy; Analgesia

Treatments: Drug: Morphine; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03428633

AsklepieionVGH

Details and patient eligibility

About

60 patients ASA I-III, undergoing open nephrectomy will be randomly assigned into one of two groups, namely group A (n=30), where a thoracic paravertebral block will be performed preoperatively and a paravertebral catheter for continuous and patient controlled bolus local anesthetic (ropivacaine) doses will be inserted and group B (n=30) where morphine IV will be administered at the beginning and the end of operation and postoperatively through patient controlled IV doses. NRS scores in static and dynamic conditions, complications, patient satisfaction, oxidative stress (through lactic acid, superoxide dismutase, malondialdehyde) and NGAL pre- and postoperatively, will be recorded.

Enrollment: 60 patients

Sex: All

Ages: 14 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Physical status according to American Society of Anesthesiologists (ASA) I-III
• Patients scheduled for open nephrectomy

Exclusion criteria

• Previous operation on same kidney
• Contraindication of paravertebral block or any of the agents used in the protocol
• BMI above 32
• Any concurrent malignancy not cured
• Serious psychiatric, mental and cognitive disorders
• Block failure
• Chronic pain
• Severe kidney disfunction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

60 participants in 2 patient groups

Group A

Active Comparator group

Description:

Thoracic paravertebral block using ropivacaine

Treatment:

Drug: Ropivacaine

Group B

Active Comparator group

Description:

Morphine IV

Treatment:

Drug: Morphine