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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01872494
• Other study ID #: local anaesthetic
• Status: Completed
• Phase: Phase 4
• First received: May 24, 2013
• Last updated: May 1, 2014
• Start date: May 2013
• Est. completion date: February 2014

Study information

• Verified date: May 2014
• Source: Guangzhou General Hospital of Guangzhou Military Command
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. ASA ? ~ ? 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• local
This group uses local analgesia infusion pump of 0.33% ropivacaine 250ml through the wound for postoperative analgesia.
• intravenous
This group is treated with intravenous analgesia pump infusion of flurbiprofen axetil 150mg,palonosetron 0.5mg,pentazocine 240mg.

Drug:
• 0.33% ropivacaine 250ml

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

Locations

Country	Name	City	State
China	Guangzhou Military Region General Hospital, Department of Anesthesiology	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou General Hospital of Guangzhou Military Command

Country where clinical trial is conducted

China, 

References & Publications (3)

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. Erratum in: Anesth Analg. 2013 Jun;116(6):1394. — View Citation

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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	sedation	At 2, 4, 6, 12, 24, 36, 48 hours after operation,sedation Ramsay scores are used to evaluate the level of sedation.	48 hours postoperation	No
Secondary	comprehensive evaluation	Investigators document the comprehensive evaluation of patients with pain control system,including the incidence of adverse reactions.	48 hours postoperation	No