The Influence of Peripheral Nerve Blocks in Patients Undergoing Limb Orthopedic Surgery

Not Applicable

Completed

• Conditions: Change; Circulatory; Surgical Injury; Pain, Postoperative
• Interventions: Procedure: 0.25% bupivacaine

• Registration Number: NCT03913650
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

To investigate pre-op peripheral nerve block in reducing peri-op IL-6 level and post-op pain

Detailed Description

In orthopedic surgery, peripheral nerve block can be used as an anesthesia adjuvant prior to surgery. In this study, we hypothesized that peripheral nerve blocks may alleviate inflammatory response and reduce the analgesics requirement. Sixty patients undergoing limb orthopedic surgery will be enrolled. Peripheral nerve block was injected with 0.25% bupivacaine under ultrasound guidance. 30 patients (Study group) underwent surgery with nerve blocks and another 30 patients (Control group) underwent surgery with morphine. The anesthetic protocol was standardized for both groups by experienced anesthesiologists. Surgical stress was assessed by blood pressure fluctuation and proinflammatory cytokine. Pain intensity was measured by numeric rating scale (NRS) score for 24 hours

Study Timeline

• Study Start: 2017-05-15
• Study First Submitted: 2017-09-17
• Primary Completion: 2018-11-30
• Study Completion: 2018-12-31
• Study First Submitted QC: 2019-04-11
• Study First Posted: 2019-04-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-15
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• diagnosis of limb fracture
• must receiving orthopedic surgery

Exclusion Criteria

• With the comorbidity of chronic heart, lung, liver and renal disease, Chronic alcoholism, Allergy to bupivacaine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nerve block(+)	0.25% bupivacaine	patient accept nerve block for post-op pain control
Morphine	0.25% bupivacaine	patient received morphine for post-op pain control

Primary Outcome Measures

Name	Time	Method
peak pain intensity in the postoperative care unit	2 hours	pain score evaluated by pain score

Secondary Outcome Measures

Name	Time	Method
change of perioperative IL-6 level	up to 6 hours	blood samples assessed by ELISA

Trial Locations

Locations (2)

Kaohsiung Municipal Siaogang Hospital; 🇨🇳 Kaohsiung, Taiwan

I-Cheng Lu; 🇨🇳 Kaohsiung, Taiwan