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

NCT01872494 | Completed Phase 4

• 1 other identifier: local anaesthetic
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

Local analgesia system; Ropivacaine; Analgesic efficacy after operation; Postoperative

Outcome Measures

Primary Outcomes (1)

• pain

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

  48 hours postoperation

Secondary Outcomes (2)

• sedation

  48 hours postoperation

• comprehensive evaluation

  48 hours postoperation

Study Arms (2)

Local

EXPERIMENTAL

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

Other: local; Drug: 0.33% ropivacaine 250ml

intravenous

ACTIVE COMPARATOR

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

Other: intravenous; Drug: flurbiprofen axetil 150mg,palonosetron 0.5mg,pentazocine 240mg.

Interventions

local OTHER

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

Local

intravenous OTHER

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

intravenous

0.33% ropivacaine 250ml DRUG

Local

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

intravenous

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Guangzhou General Hospital of Guangzhou Military Command: lead

Study Sites (1)

Guangzhou Military Region General Hospital, Department of Anesthesiology

Guangzhou, Guangdong, 510010, China

Location

Related Publications (3)

• Jirarattanaphochai K, Jung S, Thienthong S, Krisanaprakornkit W, Sumananont C. Peridural methylprednisolone and wound infiltration with bupivacaine for postoperative pain control after posterior lumbar spine surgery: a randomized double-blinded placebo-controlled trial. Spine (Phila Pa 1976). 2007 Mar 15;32(6):609-16; discussion 617. doi: 10.1097/01.brs.0000257541.91728.a1.

  PMID: 17413463 BACKGROUND

• Mekawy N M, Badawy S S I, Sakr S A. Role of postoperative continuous subfascial bupivacaine infusion after posterior cervical laminectomy: Randomized control study. Egyptian J Anaesth, 2012, 28(1): 83-88.

  BACKGROUND

• Aguirre J, Baulig B, Dora C, Ekatodramis G, Votta-Velis G, Ruland P, Borgeat A. Continuous epicapsular ropivacaine 0.3% infusion after minimally invasive hip arthroplasty: a prospective, randomized, double-blinded, placebo-controlled study comparing continuous wound infusion with morphine patient-controlled analgesia. Anesth Analg. 2012 Feb;114(2):456-61. doi: 10.1213/ANE.0b013e318239dc64. Epub 2011 Nov 10.

  PMID: 22075018 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Ropivacaine; flurbiprofen axetil; Palonosetron; Pentazocine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzomorphans; Morphinans; Opiate Alkaloids; Alkaloids; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: June 7, 2013
• Study Start: May 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: May 2, 2014

Record last verified: 2014-05

Locations

CN (1)