The Impact of Local Analgesia for Postoperative Analgesia in Posterior Thoracolumbar Operation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-02-28

Brief Summary

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Posterior thoracolumbar operation always chooses general anesthesia. Due to surgical trauma and rich periosteum and joint capsule innervation, patients after general anesthesia immediately feel acute pain.The use of appropriate postoperative analgesia in patients with thoracolumbar surgery is beneficial to postoperative recovery. Infusions of local anaesthetic via multilumen catheters that deliver directly to wound sites have been used for postoperative analgesia in procedures. Reducing the morbidity from both pain and nausea will make the mode of analgesia a better tolerated and more palatable option for patients. The aim of this study is to examine the effects of using local anaesthetic infusion catheters following posterior thoracolumbar surgery, and compares the outcomes of patients managed using intravenous analgesia pump infusion of systemic opioids.

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Detailed Description

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All 71 adult patients were prospectively included and randomized to either the local (L) group (n=35) or the intravenous (V) group (n=36) by using a random number table: the test group were treated with local analgesia infusion pump of 0.33% ropivacaine through the wound for postoperative analgesia, while the control group were treated with intravenous analgesia pump infusion of flurbiprofen axetil,palonosetron, pentazocine. At 2, 4, 6, 12, 24, 36, 48 hours after operation, postoperative pain visual analogue scale(VAS) scores and sedation Ramsay scores were used to evaluate the level of pain and sedation, and investigators documented the comprehensive evaluation of patients with pain control system, and the incidence of adverse reactions. At 24, 48 hours investigators observed the wound whether inflammation and exudation or not, and the removal of penetration catheter sent to clinical laboratory for bacterial culture. Investigators also recorded the length of time to discharge and called to ask pain conditions at the first 3 months.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Local

This group uses local analgesia infusion pump of 0.33% ropivacaine 250ml through the wound for postoperative analgesia.

Group Type EXPERIMENTAL

local

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Inclusion Criteria

1. ASA Ⅰ \~ Ⅱ patient undergoing elective posterior thoracolumbar operation
2. between 18 and 70 years of age

Exclusion Criteria

1. A history of cardiopulmonary disease, liver and kidney dysfunction, abnormal coagulation
2. Preoperative use of analgesic drugs
3. A allergy history of ropivacaine and polyurethane material

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No