None listed
Conditions
Brief summary
Low back pain is one of the leading cause of disability in an adult, working-active population representing a serious socioeconomic problem. Lumbar discectomy is the gold standard in symptomatic herniated disk treatment. Despite the advances in medicine, pharmacology and technology, postoperative pain frequency is still high. Hypothesis of this study was that opioid analgesia delivered by patient controlled pump is more effective in pain reduction compared to opioid intermittent analgesia and nonopioid analgesia after lumbar discectomy. The objectives were to determine the efficacy of two analgesics applied in different ways comparing the most effective method of analgesia. The study included 200 patients treated at the Department of Neurosurgery Sestre milosrdnice University Hospital Center, during 14 months period.
Interventions
This prospective clinical study was conducted with the participation of 200 patients who underwent elective lumbar discectomy of the intervertebral disc extrusion at level LIV – LV. After being hospitalised for lumbar discectomy, patients were introduced to the possibility of participating in the study. Patients who agreed of their own free will, based on full awareness on the research being carried out, gave their informed consent.
Patients who used PCA pump were given verbal instructions, as
This prospective clinical study was conducted with the participation of 200 patients who underwent elective lumbar discectomy of the intervertebral disc extrusion at level LIV – LV. After being hospitalised for lumbar discectomy, patients were introduced to the possibility of participating in the study. Patients who agreed of their own free will, based on full awareness on the research being carried out, gave their informed consent. Patients who used PCA pump were given verbal instructions, as well as written materials accompanied by skills and knowledge demonstration. Anaesthesiologist and a nurse with MNS degree, conducted this education. For the purpose of detailed comparison in regard to the success of different methods of analgesia administration, two analgesics are used in the research (derivate of opioid (INN) tramadol, and non-opioid (INN) paracetamol). Both analgesics were administered intermittently and by PCA pump, with schematics of daily intravenous application on the zero, first and second postoperative day. Schematics of daily tramadol application on the zero, first and second postoperative day by PCA pump: Drug concentrate: 12 mg/ml Dilution volume: 50 ml Dose unit: mg/h Soft limit (limit that can be crossed, but the device warns of high dose, recommended drug dose): 600 mg/ 24 h Device type (Infusomat/ Perfusor): Perfusor Time period for the dose: 24 h Set limits for the dose: 600 mg Bolus quantity (bolus which a patient can administer in a specific time period): 20 mg Lock time (time interval after which a patient can reapply bolus): 120 minutes Initial bolus (therapy starts with bolus): 20 mg Basal flow (continued flow during therapy): 1.38 ml/h Schematics of daily paracetamol application on the zero, first and second postoperative day by PCA pump: Drug concentrate: 10 mg/ml Dilution volume: 600 ml Dose unit: mg/h Soft limit (limit that can be crossed, but the device warns of high dose, recommended drug dose): 6000 mg/ 24 h Device type (Infusomat/ Perfusor): Infusomat Time period for the dose: 24 h Set limits for the dose: 6000 mg Bolus quantity (bolus which a patient can administer in a specific time period): 166 mg Lock time (time interval after which a patient can reapply bolus): 120 minutes Initial bolus (therapy starts with bolus): 166 mg Basal flow (continued flow during therapy): 16.6 ml/h Schematics of daily intermittent tramadol application on the zero, first and second postoperative day: 0 hours: 150 mg 6 hours: 150 mg 12 hours: 150 mg 18 hours: 150 mg Schematics of daily intermittent paracetamol application on the zero, first and second postoperative day: 0 hours: 1500 mg 6 hours: 1500 mg 12 hours: 1500 mg 18 hours: 1500 mg Pain was assessed in equal time intervals (7 PM, 7 AM, 7 PM, 7 AM, 7 PM) on the zero, first and second postoperative day) using short form of the McGill pain questionnaire (SF-MPQ) in the Croatian language.
Sponsors
Biljana Kurtovic
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The sample included 100 patients who underwent elective lumbar discectomy of intervertebral disc extrusion on level LIV – LV, diagnosed by magnetic resonance of the lumbosacral spine. Inclusive criteria for participation in the study were age (over 18), first elective surgical procedure on level LIV - LV, no analgesic allergies, no malignant and liver diseases, mental capacity to give an informed consent and the ability to use a PCA pump.
Exclusion criteria
The exclusion criteria for participation in the research were age (under 18), emergency surgery, reoperation, known analgesic allergy, malignant disease, liver conditions, immunosuppressant therapy, mental incapacity for giving informed consent, inability to use PCA pump, difficulty communicating, drug addiction. The exclusion criteria during the research was the occurrence of side-effects of administered drugs.
Outcome results
None listed