Clinical trial NCT01529190: Pregabalin on Interleukin-6 Levels in Living Donor Kidney
Official title: Effect of Preoperative Pregabalin on Pain Intensity and Interleukin-6 Levels in Living Donor Kidney
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: pregabalin
postoperative pain control
interleukin-6
acute pain
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2012-02-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pregabalin, a ligand for alfa2delta subunits of voltage-gated calcium channels, has been shown to be an effective adjuvant therapy for acute postoperative pain, by inhibiting central sensitization. The IL-6, is detectable 60 minutes after surgical incision, persisting for until 10 days, with maximal plasmatic level in 4 and 6 hours. The objective of this study is evaluating the analgesic effect of pregabalin and its repercussion on serum levels of IL6.

Detailed description: After approved by the Ethical Committee and signed informed consent, 40 patients aged from 18 until 60 years undergoing nephrectomy will be randomized in two groups. Group 1 patients will receive a single dose of 300 mg pregabalin, 1 hour before the surgical incision; group 2 patients will receive a placebo dose. Pain intensity will be assessed with the numeric rating scale. The consumption of tramadol in 24 hours after surgery and the time for the first complementation dose will be registered. Blood samples will be collected by 6 hours and 24 hours after surgical incision, for IL-6 dosage, and maintained at -70 celsus degree. The IL-6 dosages will be performed by the ELISA (enzyme-linked immunosorbent assay) method. The number of patients was calculated by Instat Graph® program. To detect difference in pain intensity of 3 between the groups by NRS, with 95% of power (estimated SD= 2.0), when the alpha level is set at 0.05, the sample should be of 20. Statistical analyses will be performed with parametric and nonparametric tests, considering the variety studied. The statistical program that will be utilized is Instat Graph®.

Eligibility criteria: Inclusion Criteria:

* living donor kidney

Exclusion Criteria:

* myocardial ischemia
* psychiatric disease
* absence of chronic pain
* absence of drugs dependency
* don´t use of opioid medication 1 week before surgery

Primary outcomes:
measure: Effect of preoperative pregabalin on pain intensity in living donor kidney
timeFrame: first 24 hours after surgery
Secondary outcomes:
measure: Effect of preoperative pregabalin on interleukin-6 levels in living donor kidney
timeFrame: first 24 hours after surgery
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Rioko K Sakata
role: STUDY_CHAIR
References:
citation: Taylor CP. Mechanisms of analgesia by gabapentin and pregabalin--calcium channel alpha2-delta [Cavalpha2-delta] ligands. Pain. 2009 Mar;142(1-2):13-6. doi: 10.1016/j.pain.2008.11.019. Epub 2009 Jan 6. No abstract available.
citation: Gray P, Kirby J, Smith MT, Cabot PJ, Williams B, Doecke J, Cramond T. Pregabalin in severe burn injury pain: a double-blind, randomised placebo-controlled trial. Pain. 2011 Jun;152(6):1279-1288. doi: 10.1016/j.pain.2011.01.055. Epub 2011 Mar 12.
citation: Baidya DK, Agarwal A, Khanna P, Arora MK. Pregabalin in acute and chronic pain. J Anaesthesiol Clin Pharmacol. 2011 Jul;27(3):307-14. doi: 10.4103/0970-9185.83672.