The Impact of Alvimopan on Return of Bowel Function After Major Spine Surgery – A Prospective, Randomized, Double-Blind Study

Neurosurgery ◽  
2019 ◽  
Vol 85 (2) ◽  
pp. E233-E239
Author(s):  
Lauren K Dunn ◽  
Robert H Thiele ◽  
Michelle C Lin ◽  
Edward C Nemergut ◽  
Marcel E Durieux ◽  
...  
Keyword(s):  
Spine Surgery ◽  
Bowel Movement ◽  
Bowel Function ◽  
Blind Study ◽  
Double Blind Study ◽  
Opioid Use ◽  
Double Blind ◽  
Pain Scores ◽  
Significant Difference ◽  
The Impact

Abstract BACKGROUND Pain management following major spine surgery requires high doses of opioids and is associated with a risk of opioid-induced constipation. Peripheral mu-receptor antagonists decrease the gastrointestinal complications of perioperative systemic opioid administration without antagonizing the analgesic benefits of these drugs. OBJECTIVE To investigate the impact of alvimopan in opioid-naive patients undergoing major spine surgery. METHODS Patients undergoing >3 levels of thoracic and/or lumbar spine surgery were enrolled in this prospective, randomized, double-blind study to receive either alvimopan or placebo prior to and following surgery. Opioid consumption; pain scores; and time of first oral intake, flatus, and bowel movement were recorded. RESULTS A total of 24 patients were assigned to the active group and 25 were assigned to the placebo group. There was no significant difference in demographics between the groups. Postoperatively, the alvimopan group reported earlier time to first solid intake [median (range): alvimopan: 15 h (3-25) vs placebo: 17 h (3-46), P < .001], passing of flatus [median (range): alvimopan: 22 h (7-63) vs placebo: 28 h (10-58), P < .001], and first bowel movement [median (range): alvimopan: 50 h (22-80) vs placebo: 64 h (40-114), P < .001]. The alvimopan group had higher pain scores (maximum, minimum, and median); however, there was no significant difference between the groups with postoperative opioid use. CONCLUSION This study shows that the perioperative use of alvimopan significantly reduced the time to return of bowel function with no increase in postoperative opioid use despite a slight increase in pain scores.

scholarly journals Perioperative Intravenous Low-Dose Ketamine Infusion to Minimize Pain for Septorhinoplasty: A Prospective, Randomized, Double-Blind Study

2020 ◽  
pp. 014556132097486
Author(s):  
Irem Ates ◽  
Muhammed Enes Aydin ◽  
Erkan Cem Celik ◽  
Mustafa Sitki Gozeler ◽  
Ali Ahiskalioglu
Keyword(s):  
Side Effects ◽  
Low Dose ◽  
Blind Study ◽  
Control Group ◽  
Anesthesia Induction ◽  
Double Blind Study ◽  
Double Blind ◽  
Ketamine Infusion ◽  
Pain Scores ◽  
Significant Difference

Objectives: Studies investigating the effects of intravenous (IV) ketamine in pain management after septorhinoplasty is limited. This study aims to evaluate the efficacy of low-dose IV infusion of ketamine on pain scores. Methods: This randomized, prospective, double-blind study was conducted with 48 patients who underwent septorhinoplasty. Intravenous ketamine bolus (0.5 mg/kg) was administered to the ketamine group (group K, n = 24) at anesthesia induction, and ketamine infusion was continued (0.25 mg/kg/h) during the surgery. In the control group (group C, n = 24), the same protocol was administered using saline instead of ketamine. Furthermore, 50-mg dexketoprofen trometamol was administered to both groups 30 minutes before the end of the surgery. Then it was repeated at the 12th and 24th hours postoperatively. Pain scores were evaluated with the visual analogue scale. Consumptions intraoperative of opioid and sevoflurane, rescue opioid requirement, patient satisfaction, and side effects were recorded. Results: Pain scores were significantly lower in group K at all postoperative periods ( P < .05). There was no significant difference between the groups in terms of intraoperative sevoflurane and remifentanil consumptions ( P > .05). Rescue opioid analgesic requirements were significantly lower in group K than group C (0/24 vs 6/24, respectively; P  = .022). Side effects were similar between the groups ( P > .05). Conclusion: We recommend the administration of low-dose ketamine infusion during septorhinoplasty surgery because it reduces the requirement for rescue opioid analgesia and postoperative pain scores.

scholarly journals Influence of catastrophizing, anxiety, and depression on in-hospital opioid consumption, pain, and quality of recovery after adult spine surgery

2018 ◽  
Vol 28 (1) ◽  
pp. 119-126 ◽  
Author(s):  
Lauren K. Dunn ◽  
Marcel E. Durieux ◽  
Lucas G. Fernández ◽  
Siny Tsang ◽  
Emily E. Smith-Straesser ◽  
...  
Keyword(s):  
Spine Surgery ◽  
Rating Scale ◽  
Psychological Intervention ◽  
Opioid Consumption ◽  
Anxiety And Depression ◽  
Opioid Use ◽  
Quality Of Recovery ◽  
Pain Scores ◽  
The Impact

OBJECTIVEPerception of perioperative pain is influenced by various psychological factors. The aim of this study was to determine the impact of catastrophizing, anxiety, and depression on in-hospital opioid consumption, pain scores, and quality of recovery in adults who underwent spine surgery.METHODSPatients undergoing spine surgery were enrolled in this study, and the preoperatively completed questionnaires included the verbal rating scale (VRS), Pain Catastrophizing Scale (PCS), Hospital Anxiety and Depression Scale (HADS), and Oswestry Disability Index (ODI). Quality of recovery was assessed using the 40-item Quality of Recovery questionnaire (QoR40). Opioid consumption and pain scores according to the VRS were recorded daily until discharge.RESULTSOne hundred thirty-nine patients were recruited for the study, and 101 completed the QoR40 assessment postoperatively. Patients with higher catastrophizing scores were more likely to have higher maximum pain scores postoperatively (estimate: 0.03, SE: 0.01, p = 0.02), without increased opioid use (estimate: 0.44, SE: 0.27, p = 0.11). Preoperative anxiety (estimate: 1.18, SE: 0.65, p = 0.07) and depression scores (estimate: 1.06, SE: 0.71, p = 0.14) did not correlate with increased postoperative opioid use; however, patients with higher preoperative depression scores had lower quality of recovery after surgery (estimate: −1.9, SE: 0.56, p < 0.001).CONCLUSIONSCatastrophizing, anxiety, and depression play important roles in modulating postoperative pain. Preoperative evaluation of these factors, utilizing a validated tool, helps to identify patients at risk. This might allow for earlier psychological intervention that could reduce pain severity and improve the quality of recovery.

scholarly journals Role of pre–extubation fentanyl in mastectomy: a randomized, controlled, double–blind study

2021 ◽  
Vol 25 (2) ◽  
Author(s):  
Ahmed Salman ◽  
Norma Osama Zayed ◽  
Ahmed Mansour ◽  
Ramy Howaidi ◽  
Ahmed Gamaleldin Foly ◽  
...  
Keyword(s):  
Short Form ◽  
Cardiovascular Responses ◽  
Blind Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Randomized Controlled ◽  
Arterial Blood ◽  
Extubation Time ◽  
Significant Difference

Background: Both tracheal intubation and extubation are associated with dangerous consequences such as tachycardia, hypertension, myocardial ischemia and arrhythmias. The aim was to evaluate pre–extubation two different doses of fentanyl on hemodynamic stabilization and delayed recovery in mastectomy. Methodology: The randomized controlled double–blind study was conducted on 126 patients aged 16–60 years, with controlled hypertension, receiving chemotherapy before surgery and underwent mastectomy for breast cancer. Patients were randomly allocated into 3 equal groups. Before extubation, patients received 10 ml saline in group (C), 1 µg/kg fentanyl in Group–F1: and 2 µg/kg fentanyl in Group–F2. Mean arterial blood pressure (MAP) and heart rate (HR) were recorded at T1 (after maintenance of anesthesia), T2 (after giving the test drug), T3 (immediately after extubation), T4 (5 min. after extubation) and T5 (15 min after extubation). Results: MAP was significantly lower in fentanyl groups compared to Group–C at T2 and T3 without significant deference between fentanyl groups. HR was significantly lower in fentanyl groups compared to Group–C and in Group–F2 compared to Group–F1 at T3, T4 and T5. Time of extubation was significantly prolonged in Group–F2 compared to Group–F1 and Group–C without a significant difference between Group–F1 and Group–C. Conclusions: Pre–extubation fentanyl 1 µg/kg blunted cardiovascular responses to extubation without respiratory depression or prolonged recovery. Pre–extubation fentanyl 2 µg/kg provide more control in HR but with delay in the extubation time compared to 1 µg/kg of fentanyl. Key words: Pre–Extubation, Fentanyl, Mastectomy, Hemodynamics, Recovery Preregistration: The study was registered in the Ethical Committee of Faculty of Medicine, Cairo University, Cairo, Egypt (approval number: 281) Citation: Salman A, Zayed NO, Mansour A, Howaidi R, Foly AG, ElSharkawy MS, Abdelgalil AS. Role of pre–extubation fentanyl in mastectomy: a randomized, controlled, double–blind study. Anaesth. pain intensive care 2021;25(2):143-149. DOI: 10.35975/apic.v25i2.1462. Abbreviations: CST=Craniosacral therapy; SMT=Sensorimotor training; NCLBP=Nonspecific chronic low back pain; VAS=Visual analogue scale; ODI=Oswestry disability index, BDI-II=Beck depression inventory-II, and SF-36=Short Form-36; CSF=cerebral spinal fluid; CSS=craniosacral system; PRM=primary respiratory movements Received: 27 June 2020, Reviewed: 24 July 2020, Accepted: 27 July 2020

The role of tolvaptan in prevention of hyponatremia in patients undergoing transurethral resection of prostate surgery- A randomized double blind study

2021 ◽  
Vol 8 (2) ◽  
pp. 321-325
Author(s):  
Dinesh Kumar Singh ◽  
B B Baj ◽  
Vipin Goyal
Keyword(s):  
Transurethral Resection ◽  
Blind Study ◽  
Transurethral Resection Of Prostate ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Group A ◽  
The Mean ◽  
Group B

The aim of our study to determine the role of tolvaptan in prevention of hyponatremia in transurethral resection of prostate surgery. This is randomized double-blind study conducted in 60 ASA grade status 1 and 2 patients age group between 45-80 yrs undergoing TURP under spinal anaesthesia in urology operation theatre in Mahatma Gandhi hospital Jaipur after receiving permission from hospital ethical committee. A detailed history, complete physical examination and routine investigation were done for all patients followed by informed written consent was obtained. Patients are randomly divided into 2 groups. In group A -30 patients who received orally tab tolvaptan 15 mg and group B-30 patients who received orally tab multivitamin 2 hrs before surgery after doing electrolytes of the patients in the morning. In both groups age (in yrs), wt (in kg), ASA grade, volume of irrigating fluid (in litres), volume of prostate resected (in gm) and duration of surgery (in minutes) all demographic and surgical details data were compared. Electrolytes were compared in both groups pre and post-operatively and statistical analysis was done.There was significant difference in post-operative sodium level between the two groups (A and B). The mean level of sodium significantly reduced post-operatively in group –B (control grp). The mean level of sodium significantly increased post-operatively in group –A (tolvaptan grp). We conclude single dose of tolvaptan -15 mg found to effective in prevention of hyponatremia in patients undergoing TURP.

scholarly journals Diclofenac in Combination with Opiate Infusion after Joint Replacement Surgery

1991 ◽  
Vol 19 (4) ◽  
pp. 535-538 ◽  
Author(s):  
S. K. Anderson ◽  
B. A. Al Shaikh
Keyword(s):  
Blood Loss ◽  
Joint Replacement ◽  
Blind Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Gastrointestinal Complications ◽  
Visual Analogue Pain ◽  
Joint Replacement Surgery ◽  
Replacement Surgery ◽  
Pain Scores

The effect of intramuscular diclofenac or placebo on analgesia obtained and on opiate and antiemetic requirements was observed in a randomised double-blind study of sixty patients receiving continuous intravenous papaveretum. Those patients receiving diclofenac required less papaveretum (P = 0.001) than those receiving placebo. They also had lower visual analogue pain scores (VAS) at four hours (P < 0.05) and decreased requirement for antiemetics (P < 0.02). No gastrointestinal complications were observed in either group and blood loss did not differ significantly between the two.

A Double-Blind Out-Patient Trial of Indalpine vs Mianserin

1985 ◽  
Vol 147 (3) ◽  
pp. 306-309 ◽  
Author(s):  
G. J. Naylor ◽  
B. Martin
Keyword(s):  
Side Effects ◽  
Treated Group ◽  
Blind Study ◽  
Antidepressant Effect ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference

SummaryIndalpine 150 mg per day and mianserin 60 mg per day were compared in a double-blind study of 65 depressed out-patients: 52 patients completed the 4-week trial. At the end of four weeks there was no significant difference in antidepressant effect between the two drugs; but in the first two weeks, improvement in the mianserin-treated group was significantly greater than that in the indalpine group. The mianserin-treated group reported more side-effects of sedation (eg. drowsiness, clumsiness, heaviness of limbs etc.) and one patient on indalpine developed a mild leucopenia.

scholarly journals Impact of Compliance on Elastic Compression Stockings Efficacy to Prevent Post-Thrombotic Syndrome: A Prespecified Analysis of the Celest Double-Blind Study

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 2127-2127
Author(s):  
Jean philippe Galanaud ◽  
Genty Celine ◽  
Alexa Comte ◽  
Carole Rolland ◽  
Francois Verriere ◽  
...  
Keyword(s):  
Independent Predictor ◽  
Blind Study ◽  
Double Blind Study ◽  
Multivariable Model ◽  
Compression Stockings ◽  
Open Label ◽  
Double Blind ◽  
Tree Algorithm ◽  
The Impact

Abstract Introduction: Elastic compression stockings (ECS) are commonly used for the prevention of post-thrombotic syndrome (PTS) after deep venous thrombosis (DVT). However, their efficacy is controversial. While two open-label studies reported a 50% risk reduction of PTS in the ECS vs. no-ECS groups, a large double-blind study didn't find any benefit of ECS vs. placebo-ECS to prevent PTS. These opposite results could be explained either by a placebo effect in the open-label studies or to a lack of compliance to study ECS in the double-blind study. Additional data on the impact of compliance on ECS efficacy, obtained in a double-blind way, are therefore needed. Methods: We analyzed data from the French, CELEST, multicentre double-blind trial comparing 25mmHg ECS vs. 35mmHg ECS to prevent PTS at 2 years after a first symptomatic ipsilateral proximal DVT (NCT01578122). All CELEST patients who had complete data for primary outcome (i.e. PTS, defined as a Villalta score ≥5 on the DVT affected leg at the one- or 2-year follow up visit) were included. The objectives of this predefined analysis were to: i) compare the incidences of PTS at 2 years according to compliance to ECS (irrespective of allocated treatment group) during the first 3 months of treatment and during the 2-year follow-up; ii) assess independent predictors of PTS using a stepwise multivariable model including all of the following variables (baseline patients' and DVT characteristics, anticoagulant treatment and compliance to ECS) if they achieved a p value of 0.2 or less in univariate analysis as well as ECS strength allocation group; iii) build an induction tree algorithm to measure the impact in terms of incidence of PTS of each of the independent predictor of PTS. Compliance to ECS was defined as reasonable and optimal if the patient had worn the study ECS more than 50% and more than 80% of the time respectively and had a modified GIRERD score of 0-2. Results: 249 patients were eligible for this analysis. Mean baseline age was 57 years, 70% (n=174) were men, 20% (n=50) were obese, 21% (n=52) had previous VTE event, 7% (n=18) had a baseline Villalta score ≥5 and the most proximal extent of DVT was the iliac vein in 15% (n=37) of cases. In 80% (n=179) of cases patients were treated with anticoagulation for more than 6 months after DVT and a direct oral anticoagulant (DOAC) was used in 69% (n=164) of cases. 32 % (n=80) of patients developed PTS at 2 years. When patients wore study ECS&gt;80% of the time (i.e optimal compliance), incidence of PTS over 2 years was 26.1% (n=31). Incidence of PTS was 25.0% (n=10) and 40.5% (n=34) in those patients who wore ECS 50-80% and &lt;50% of the time, p=0.06. When comparing patients who never wore study ECS (compliance&lt;50% during the whole study follow-up) to those who were reasonably compliant during the whole study follow-up, incidence of PTS was respectively 46.4% (n=13) vs. 25.3% (n=38), p=0.02. Results of the univariate and multivariate analyses are presented in Table 1 and induction tree algorithm is provided in Figure 1. Conclusions: In our double bling study assessing 25mmHg vs. 35mmHg ECS to prevent PTS, compliance to ECS was a significant independent predictor of PTS in our multivariable model. Impact of ECS use became apparent when patient used ECS at least 50% of the time without any strong benefit beyond. Wearing study ECS&gt;50% of the time was associated with 2-fold decreased risk of developing PTS, which is consistent with the results from previous 'positive' open-label studies. It suggests that use of ECS influences the risk of developing PTS. Our induction tree algorithm evidences that being compliant with ECS seems particularly beneficial in - non-obese - patients with extensive DVT. Figure 1 Figure 1. Disclosures Verriere: Laboratoires Innothera: Current Employment.

Double-Blind Study of Dothiepin versus Placebo in the Treatment of Primary Fibromyalgia Syndrome

1987 ◽  
Vol 15 (3) ◽  
pp. 154-159 ◽  
Author(s):  
I. Caruso ◽  
P. C. Sarzi Puttini ◽  
L. Boccassini ◽  
S. Santandrea ◽  
M. Locati ◽  
...  
Keyword(s):  
Side Effects ◽  
Fibromyalgia Syndrome ◽  
Blind Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Clinical Variables ◽  
Primary Fibromyalgia ◽  
Significant Difference ◽  
Primary Fibromyalgia Syndrome

A double-blind study comparing the efficacy and tolerability of dothiepin with that of placebo in the treatment of primary fibromyalgia syndrome was carried out. Dothiepin was shown to improve significantly the condition of patients with primary fibromyalgia syndrome and there was a significant difference between dothiepin and placebo in all the clinical variables measured. Only mild and transient side-effects were reported. Further controlled studies are required to define the effects of dothiepin on fibromyalgia.

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