Evaluation of analgesic action of morphine given in peripheral tissues in patients undergoing major spine surgery.
Not Applicable
Recruiting
- Conditions
- Health Condition 1: null- Patient with or without mild systemic disease (ASA I and II),undergoing major spine surgery with surgical duration upto 4 hours
- Registration Number
- CTRI/2014/12/005315
- Lead Sponsor
- Department of Anaesthesiology Pain and Perioperative Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1.ASA I/II
2.Age 20-65 years
3.Weight of >45 kg to < 75 kg
4.Major Spine surgery 2 to 4 levels,with or without fixation.
Exclusion Criteria
1.Consent refusal
2.Body-weight: <45 or >75 kg
3.Allergic to opioids/local anaesthetics
4.Any decompensating systemic illness (renal, hepatic, cardiac, respiratory, etc.)
5.Coagulation disorder
6.Neurologic/psychiatric disorder/drug dependence/substance abuse
7.ASA physical status: III/IV
8.Inadvertent dural-rent during surgery
9.Blood loss necessitating transfusion
10.Prolonged surgical duration (>=4-hours)
11.Perioperative ionotrope/vasopressor use
12.Need for elective postoperative ventilation
13. History of previous spine surgery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Peripheral morphine analgesia assessment <br/ ><br>2.Time-to-first rescue analgesia <br/ ><br>3.The requirement of postoperative intravenous patient-controlled analgesia (IV-PCA) <br/ ><br>Timepoint: Extubation to 72 hours after the procedure
- Secondary Outcome Measures
Name Time Method 1.Total IV-PCA fentanyl consumption <br/ ><br>2.Side effects (respiratory distress, nausea, vomiting, etc.) specific to morphine infiltration <br/ ><br>3.Patient satisfaction <br/ ><br>Timepoint: Extubation to 72 hours after the procedure