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1.
Qual Life Res ; 27(11): 3013-3020, 2018 Nov.
Article in English | MEDLINE | ID: mdl-30073471

ABSTRACT

PURPOSE: Pain has a negative impact on life satisfaction (LS). Our primary aims were to compare LS in on-opioid and opioid-naïve spine surgery patients and to evaluate whether surgery affects LS during the first 3 weeks after surgery. METHODS: After informed consent 200 patients (99 on-opioid, 101 opioid-naïve; 112 male; aged 23-71 years) having elective spine surgery were enrolled. Their LS was evaluated using a four-item Life Satisfaction Scale (4-20, lower score more satisfied) and pain interference using Brief Pain Inventory (BPI)-questionnaire (0-10, lower score, less interference) before and 21 days after surgery. RESULTS: At baseline LS was lower in the ON-OPIOID-group, mean LS-score 10.6 (SD 3.9), than that in the OPIOID-NAÏVE-group, 9.3 (3.0) (p = .027). At 3 weeks after surgery LS had increased in both groups compared to baseline (p < .001). However, LS was still lower in the ON-OPIOID-group, 9.1 (3.7) than that in the OPIOID-NAÏVE-group, 7.6 (2.7) (p = .005). Patients with lower LS experienced more pain interference pre- and post-operatively (p < .001). At 3 weeks the pain interference had decreased in both groups, in the ON-OPIOID-group from mean BPI-score 5.1 (2.0) to 3.0 (2.0) (p < .001) and in the OPIOID-NAÏVE-group from 4.0 (2.1) to 2.4 (2.3) (p < .001), but BPI-score was still higher in the ON-OPIOID-group (p = .045). CONCLUSION: Life satisfaction increased and pain interference decreased in both groups after spine surgery. However, LS was lower and pain interference was more significant in on-opioid patients than that in opioid-naïve patients.


Subject(s)
Analgesics, Opioid/therapeutic use , Pain Measurement , Pain/drug therapy , Personal Satisfaction , Quality of Life/psychology , Spine/surgery , Acetaminophen/therapeutic use , Adult , Aged , Drug Combinations , Elective Surgical Procedures , Female , Humans , Ketoprofen/analogs & derivatives , Ketoprofen/therapeutic use , Male , Meloxicam/therapeutic use , Middle Aged , Naltrexone/therapeutic use , Oxycodone/therapeutic use , Pain/psychology , Prospective Studies , Surveys and Questionnaires , Tromethamine/therapeutic use , Young Adult
2.
Adv Ther ; 34(1): 236-251, 2017 01.
Article in English | MEDLINE | ID: mdl-27921252

ABSTRACT

INTRODUCTION: Opioids are needed for postoperative pain in spine surgery patients, but opioid-induced constipation is a harmful adverse event. The aim of this clinical trial was to compare the use of a controlled-release oxycodone-naloxone combination product with oxycodone controlled-release tablets in these patients. The main outcome measure was the prevalence of constipation at 7 days postoperatively assessed with a Bowel Function Index questionnaire. A follow-up assessment at 21 days after surgery was also included. METHODS: A total of 180 patients undergoing spine surgery, 91 having preoperative opioids in use and 89 opioid-naïve, were randomized to receive twice-daily oxycodone 10 mg or oxycodone-naloxone 10/5 mg controlled-release tablets for the first 7 postoperative days. Patients were followed-up for 21 days after surgery. RESULTS: At baseline, prevalence of constipation was common both in the opioid-naïve-25/87 (29%) and on-opioid groups 43/90 (48%) (P = 0.009). This increased at 7 days postoperatively with no difference between the groups, 54/89 with oxycodone and 54/88 with oxycodone-naloxone had constipation. At 21 days, constipation was less than in the baseline in both groups, in the opioid-naïve group the prevalence of constipation was 3/43 (7%) in patients with oxycodone-naloxone compared to 9/44 (21%) with oxycodone (effect size 0.68; P = 0.068). Both study compounds provided similar pain relief and were well tolerated. CONCLUSION: In patients presented for back surgery, the prevalence of constipation was significantly higher than that in the community. In opioid-naïve subjects, oxycodone-naloxone was beneficial concerning constipation; but this was not distinguishable in subjects with chronic opioid use. The analgesic efficacy of oxycodone and oxycodone-naloxone was similar. TRIAL REGISTRATION: European Clinical Trials Database (EudraCT no. 2012-001816-42) and ClinicalTrials.gov database (Identifier: NCT02573922).


Subject(s)
Analgesics, Opioid/therapeutic use , Constipation/chemically induced , Constipation/prevention & control , Naloxone/therapeutic use , Oxycodone/therapeutic use , Pain, Postoperative/drug therapy , Adult , Aged , Analgesics, Opioid/administration & dosage , Analgesics, Opioid/adverse effects , Delayed-Action Preparations , Drug Combinations , Female , Humans , Male , Middle Aged , Naloxone/administration & dosage , Naloxone/adverse effects , Neurosurgical Procedures/adverse effects , Outcome Assessment, Health Care , Oxycodone/administration & dosage , Oxycodone/adverse effects , Prospective Studies , Single-Blind Method , Surveys and Questionnaires
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