Clinical Trials Directory

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UnknownNCT02114463

Comparison of Two Kinds of Postoperative Analgesia After Amputation

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

Status
Unknown
Phase
Phase 4
Study type
Interventional
Enrollment
36 (estimated)
Sponsor
Guangzhou General Hospital of Guangzhou Military Command · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURELocal analgesicPatient will be performed under combined lumbar plexus and sciatic nerve block with 0.33% ropivacaine.At the end of surgery,two catheters are left in the wound.One is intraarticular and the other is on the surface of articular cavity.And then a pump elastomeric infusion pump will be connected with the catheters, which runs 5mL every hours.
PROCEDUREIntravenous analgesicPeople in this group will also receive an anesthesia of combined lumbar plexus and sciatic nerve block with 0.33% ropivacaine.An intravenous electronic analgesia pump infusion of flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg will will provide postoperative pain management.The patients will received a 2 mL/h continuous basal infusion and 1 mL boluses with a lockout time of 30 min after a 5 mL Loading dose at the end of the surgery.
DRUGropivacaine0.2% ropivacaine
DRUGflurbiprofenflurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg

Timeline

Start date
2014-03-01
Primary completion
2016-08-01
Completion
2016-08-01
First posted
2014-04-15
Last updated
2015-03-12

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT02114463. Inclusion in this directory is not an endorsement.