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NCT Number: NCT01872494

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

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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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Guangzhou Military Region General Hospital, Department of Anesthesiology

Guangzhou, Guangdong, 510010, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA Ⅰ ~ Ⅱ patient undergoing elective posterior thoracolumbar operation
  • between 18 and 70 years of age

Exclusion criteria

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

Treatment and study plan

local

Other

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

intravenous

Other

This group is treated with intravenous analgesia pump infusion of flurbiprofen axetil 150mg,palonosetron 0.5mg,pentazocine 240mg.

0.33% ropivacaine 250ml

Drug

flurbiprofen axetil 150mg,palonosetron 0.5mg,pentazocine 240mg.

Drug

Primary outcomes

  1. pain

    Time frame: 48 hours postoperation

    Up to 48 hours after operation,postoperative pain visual analogue scale(VAS) scores are used to evaluate the level of pain.

Secondary outcomes

  1. sedation

    Time frame: 48 hours postoperation

    At 2, 4, 6, 12, 24, 36, 48 hours after operation,sedation Ramsay scores are used to evaluate the level of sedation.

  2. comprehensive evaluation

    Time frame: 48 hours postoperation

    Investigators document the comprehensive evaluation of patients with pain control system,including the incidence of adverse reactions.

Sponsors and collaborators

Lead sponsor

Guangzhou General Hospital of Guangzhou Military Command

Other

Registry information

Official study title

Pain Treatment in Posterior Thoracolumbar Operation a Randomized Study to Assess the Effect of Local Analgesia After Operation

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 7, 2013
Registry last updated
May 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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