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

Guangzhou General Hospital of Guangzhou Military Command

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: 0.33% ropivacaine 250ml; Drug: flurbiprofen axetil 150mg,palonosetron 0.5mg,pentazocine 240mg.; Other: intravenous; Other: local

Study type: Interventional

Funder types: Other

Identifiers

NCT01872494

local anaesthetic

Details and patient eligibility

About

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.

Full 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.

Enrollment: 71 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ASA Ⅰ ~ Ⅱ 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

Local

Experimental group

Description:

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

Treatment:

Drug: 0.33% ropivacaine 250ml

Other: local

intravenous

Active Comparator group

Description:

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

Treatment:

Other: intravenous

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