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Effect of Blocking a nerve in the neck and arm on inflammation in shoulder surgery. Comparative study

Effect of Interscalene Block on the inflammatory response in Shoulder surgery. Comparative study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8bn3y2
Enrollment
Unknown
Registered
2018-07-26
Start date
2014-04-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Rotator cuff lesions, adhesive capsulitis, glenohumeral instability and subacromial impingement.

Interventions

Procedure/surgery
20 patients were randomly assigned using a computer-generated random number in a 1:1 relation. Control group: 10 patients were assigned to balanced general anesthesia (BGA). Experimental group: 10 pa

Sponsors

Instituto Nacional de Rehabilitación
Lead Sponsor
Instituto Nacional de Rehabilitación
Collaborator

Eligibility

Age
35 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients scheduled for arthroscopic surgery of the shoulder; Patients of both genders; Patients from 35 to 70 years age Patients with American Society Anesthesiologists (ASA) physical status classification I or II; Patients who agree to participate in the study; Patients with leukocyte count within normal (count among 4 x 103/mm3 and 11 x 103/mm3)

Exclusion criteria

Exclusion criteria: Patients with obesity (body mass index higher 30 Kg/m2); Patients with malnutrition; diabetes mellitus; metabolic syndrome; pre-existing coagulopathy; acute or chronic focus of infection; congenital or acquired immunological disease; collagen disease; local or systemic inflammatory disease; endocrine disease; oncological disease; psychiatric illness; organ failure; chronic pain in another bodily region; use of steroids or immunomodulators; chronic use of non-steroidal anti-inflammatory drugs; chronic use of alpha2-adrenergic agonists; previous surgery of the same shoulder and airway difficulties.

Design outcomes

Primary

MeasureTime frame
On the basis of previous studies of the influence of anesthetic techniques on the release of proinflammatory cytokines (TNF, IL-6 and IL-1) in several surgical procedures, a sample size calculation was made to compare paired measurements (one baseline and another after the intervention) in two study groups. The Sample Size Calculator of Statulator beta (http://statulator.com/SampleSize/ss2PM.html) was used taking the difference of the baseline and final IL-6 average in each study group (3.89) and the variance of the two differences (7.56), with a beta value of 0.80 and an alpha level of 0.05, estimating that at least 8 patients would be required to demonstrate statistically significant differences. By adding 20% of possible losses during the study, a final n of 10 patients was obtained for each study group. With a minimum of 8 hours fasting, quantification of Interleukin (IL) -1a, IL-1b, IL-1RA, IL-2, sIL-2RA, IL-6, IL-10, IL-12p40, IL-17, interferon gamma-induced protein 10 kDa (IP-10), monocyte chemoattractant protein (MCP) -1, macrophage inflammatory protein (MIP) -1a, MIP-1b, tumor necrosis factor (TNF) -a, vascular endothelial growth factor (VEGF) and eotaxin, erythrocyte sedimentation rate (ESR), high sensitivity C-reactive protein (CRP) and leukocyte concentration (WBC) from 9 ml of venous blood on three occasions: pre-anesthesia, immediate postoperative and 24 hours postoperative was performed for each patient.;ESR, CRP and leukocytes increased significantly at 24 h after surgery, however, the increase in ESR (p = 0.002) and CRP (p = 0.000) was lower in the SDIB group. There was a significant increase in sIL-2RA (p = 0.041) and IL-12p40 (p = 0.018) in the immediate postoperative period in the SDIB group.

Secondary

MeasureTime frame
Presence and intensity of postoperative pain assessments were performed three times (immediate, 12 and 24 hours postoperative).;Immediate postoperative pain showed a significant increase (p = 0.000) in the BGA group.

Countries

Mexico

Contacts

Public ContactGabriel Mejía-Terrazas

Hospital Ángeles México

gisibyg@yahoo.com.mx+52 55 21097872

Outcome results

None listed

Source: REBEC (via WHO ICTRP)