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Clinical Trials/NCT02114463
NCT02114463
Unknown
Phase 4

Comparison of Two Kinds of Postoperative Analgesia After Amputation:a Randomized Clinical Trial

Guangzhou General Hospital of Guangzhou Military Command1 site in 1 country36 target enrollmentMarch 2014

Overview

Phase
Phase 4
Intervention
Local analgesic
Conditions
Pain
Sponsor
Guangzhou General Hospital of Guangzhou Military Command
Enrollment
36
Locations
1
Primary Endpoint
pain
Last Updated
11 years ago

Overview

Brief Summary

Pain after amputation is a significant problem among amputees. Phantom limb pain may appear in up to 85% of patients and is usually resistant to a wide variety of treatments.It is believed that regional anesthesia, by preventing the establishment of central sensitization, may play a role in reducing the incidence of acute and chronic pain. Therefore the investigators will compare two methods of postoperative analgesic after after amputation by their efficiency and complication.

Detailed Description

Peripheral nerve transection results in an afferent nociceptive barrage that initiates spinal cord hyperexcitability with expansion of the receptive fields of dorsal horn neurons that respond to the nearest intact afferents. These neuroplastic changes are believed to be responsible for the development of postsurgical chronic pain syndromes, including phantom limb and stump pain.At present, there are no randomized studies with sample sizes that ensure power, or blinded for end-point assessment,to support the evidence on pharmacological and non-pharmacological treatments of Pain after amputation. Consequently, our study was designed to arrive at clear conclusions about treatment efficacy and to give stronger recommendations for clinical practice.

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
August 2016
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Guangzhou General Hospital of Guangzhou Military Command
Responsible Party
Principal Investigator
Principal Investigator

bo xu

associate chief physician

Guangzhou General Hospital of Guangzhou Military Command

Eligibility Criteria

Inclusion Criteria

  • Patients of American Association of anesthetists(ASA)Grade 1 or 2
  • Aged between 18 and 65 years
  • Undergoing elective total knee replacement

Exclusion Criteria

  • Mental illness can not match
  • Nerve block, epidural anesthesia contraindicated
  • People who have Slow-type arrhythmias
  • History of chronic headaches and long-term use of analgesic drugs
  • People who were postoperative consciousness, language or hearing impaired

Arms & Interventions

Local analgesic

This group uses local analgesia infusion pump of 0.2% ropivacaine 360ml through periarticular infiltration for postoperative analgesia.

Intervention: Local analgesic

Local analgesic

This group uses local analgesia infusion pump of 0.2% ropivacaine 360ml through periarticular infiltration for postoperative analgesia.

Intervention: ropivacaine

Intravenous analgesic

This group is treated with intravenous electronic analgesia pump infusion of flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg.

Intervention: Intravenous analgesic

Intravenous analgesic

This group is treated with intravenous electronic analgesia pump infusion of flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg.

Intervention: flurbiprofen

Outcomes

Primary Outcomes

pain

Time Frame: 72 hours postoperation

Up to 72 hours after operation,postoperative pain visual analogue scale(VAS) scores are used to evaluate the level of pain.

Secondary Outcomes

  • Phantom pain(three months postoperation)
  • complication(72 hours postoperation)

Study Sites (1)

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