scholarly journals Perioperative Anxiolytic and Analgesic Effects of Pregabalin in Vitreo-Retinal Surgery: A randomized, double-blind study

2021 ◽  
Vol 11 (4) ◽  
Author(s):  
Ayman Elrashidy ◽  
Ahmed Metwally Khattab ◽  
Zeinab Ahmed Elseify ◽  
Mohamed E Oriby
Keyword(s):  
Placebo Group ◽  
Controlled Trial ◽  
Needle Insertion ◽  
Anxiety Score ◽  
Control Group ◽  
Double Blind Study ◽  
Double Blind ◽  
Analgesic Effects ◽  
Peribulbar Block ◽  
American Society

Objectives: This study was done to examine the effect of a single, one-time pregabalin dose on postoperative pain, anxiety, and analgesic consumption after vitrectomy performed under the peribulbar block and to assess the satisfaction of the patients as well as the surgeons. Methods: This randomized, double-blinded, placebo-controlled trial was conducted at Magrabi Eye, ENT and Dental Center, Doha, Qatar on 58 adult patients aged 37 - 75 years, who met status I and II of the American Society of Anesthesiologists (ASA) and scheduled for elective vitrectomy, under the peribulbar block (PB). Of the total participants, 30 cases were randomized to receive pregabalin, while the remaining received placebo 90 minutes before surgery. Pain was assessed using a Verbal Analog Scale (VAS) score, and the levels of anxiety were gauged by verbal anxiety score. Results: Patients who received pregabalin had a significantly higher sedation score (3 ± 0 vs. & 2 ± 0.65; P < 0.05), and a significantly less anxiety score (3 ± 1.3 vs. 5 ± 1.6; P < 0.001) compared to the control group. During needle insertion for PB, patients in the pregabalin group experienced less pain compared to the control group (32 ± 15 vs. 44 ± 15; P < 0.05). Pregabalin group showed a significantly higher cooperation rate and patient satisfaction scores (3.2 ± 0.7 and 3.8 ± 0.4, respectively), compared to the placebo group (2.8 ± 0.7 and 3.4 ± 0.5, respectively). The placebo group required intraoperative midazolam more in comparison to the pregabalin group (19 vs. 5; P < 0.001). Moreover, the need for postoperative analgesia was more in the placebo group two hours postoperatively. Conclusions: Pregabalin is a potent premedication in controlling post-surgical pain and anxiety in patients undergoing vitrectomy under the PB.

Effects of the Preoperative Administration of Dexketoprofen Trometamol on Pain and Swelling After Implant Surgery: A Randomized, Double-Blind Controlled Trial

2018 ◽  
Vol 44 (2) ◽  
pp. 122-129
Author(s):  
Arturo Sánchez-Pérez ◽  
Jesús Muñoz-Peñalver ◽  
María José Moya-Villaescusa ◽  
Carmen Sánchez-Matás
Keyword(s):  
Placebo Group ◽  
Postoperative Pain ◽  
Controlled Trial ◽  
Test Group ◽  
Control Group ◽  
Double Blind ◽  
Implant Surgery ◽  
Lower Pain ◽  
Dexketoprofen Trometamol ◽  
Group A

The fear of postoperative pain is often mentioned by patients as one of the factors that is most frequently associated with dental implants. To reduce this factor, a single oral dose of 25 mg dexketoprofen trometamol (DKT) or placebo was administered 15 minutes before implant surgery. One hundred patients who required single-implant treatments were randomly assigned to 1 of 2 blinded groups. The patients in the test group were given 25 mg DKT (DKT group), and those in the control group were given 500 mg vitamin C as a placebo (PLACEBO group). A subjective visual analogue scale of 100 mm in length was used to evaluate pain. Inflammation and complications were assessed using a 5-point Likert scale. An analysis of variance, t-tests, and a Mann-Whitney U test were performed. Among the 100 patients, 83 completed the study (there were 8 dropouts in the PLACEBO group and 9 in the DKT group). The patients who received DKT reported a lower pain intensity during the immediate postoperative period. The inflammatory response was weaker in the DKT group than the control group at 48 hours, but bleeding was greater. There were no other complications in either of the groups. In conclusion, the preemptive use of 25 mg soluble DKT administered orally 15 minutes before implant surgery can reduce the severity of immediate postoperative pain.

Effects of synbiotic supplementation and lifestyle modifications on women with polycystic ovary syndrome

2021 ◽  
Author(s):  
Izabela Chudzicka-Strugała ◽  
Anna Kubiak ◽  
Beata Banaszewska ◽  
Barbara Zwozdziak ◽  
Martyna Siakowska ◽  
...  
Keyword(s):  
Placebo Group ◽  
Polycystic Ovary Syndrome ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Reproductive Age ◽  
Control Group ◽  
Lifestyle Modifications ◽  
Ovary Syndrome ◽  
Double Blind ◽  
Synbiotic Supplementation

Abstract Context Polycystic ovary syndrome (PCOS) is the most common endocrinopathy affecting women of reproductive age. Objective This study was designed to evaluate effects of lifestyle modifications and synbiotic supplementation on PCOS. Design A randomized (1:1) double-blind, placebo-controlled trial. Setting Academic hospital. Patients or Other Participants Overweight and obese women with PCOS were identified according to the Rotterdam criteria. Evaluations were performed at baseline and repeated after 3 months of treatment. Intervention Lifestyle modifications in combination with synbiotic supplementation or placebo. Main Outcome Measures Change in BMI and testosterone level. Results In the Placebo Group, a 5% decrease in BMI was accompanied by significant decreases of the waist, hip, and thigh circumferences. The Synbiotic Group experienced an 8% decrease in BMI, which was significantly greater than that in the Control Group (P=0.03) and was accompanied by decreases in the waist, hip, and thigh circumferences. Testosterone did not decrease significantly in the Placebo Group (decrease of 6%), while in the Synbiotic Group it decreased by 32% (P&lt;0.0001). The decrease of testosterone was significantly greater in the Synbiotic Group than in the Placebo Group (P=0.016). Conclusions Synbiotic supplementation potentiated effects of lifestyle modifications on weight loss and led to significant reduction of serum testosterone.

scholarly journals Comparison of bolus administration effects of lidocaine on preventing tourniquet-induced hypertension in patients undergoing general anesthesia: a randomized controlled trial

2021 ◽  
Author(s):  
Ji WooK Kim ◽  
A Ran Lee ◽  
Eun Sun Park ◽  
Min Su Yun ◽  
Sung Won Ryu ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Controlled Trial ◽  
Control Group ◽  
Double Blind Study ◽  
Bolus Administration ◽  
Double Blind ◽  
Single Bolus ◽  
Randomized Controlled ◽  
Induced Hypertension ◽  
Tourniquet Inflation

Background: This study assessed the effect of a single bolus administration of lidocaine on the prevention of tourniquet-induced hypertension (TIH) and compared the effect of lidocaine to that of ketamine in patients undergoing general anesthesia.Methods: This randomized, controlled, double-blind study included 75 patients who underwent lower limb surgery using a tourniquet. The patients were administered lidocaine (1.5 mg/kg, n = 25), ketamine (0.2 mg/kg, n = 25) or placebo (n = 25). The study drugs were administered intravenously 10 min before tourniquet inflation. Systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR) were measured before tourniquet inflation, after tourniquet inflation for 60 min at 10 min intervals, and immediately after tourniquet deflation. The incidence of TIH, defined as an increase of 30% or more in SBP or DBP during tourniquet inflation, was also recorded.Results: SBP, DBP, and HR increased significantly over time in the control group compared to those in the lidocaine and ketamine groups for 60 min after tourniquet inflation (P < 0.001, P < 0.001, and P = 0.007, respectively). The incidence of TIH was significantly lower in the lidocaine (n = 4, 16%) and ketamine (n = 3, 12%) group than in the control group (n = 14, 56%) (P = 0.001). Conclusion: Single-bolus lidocaine effectively attenuated blood pressure increase due to tourniquet inflation, with an effect comparable to that of bolus ketamine.

Intravenous Immunoglobulin Therapy for Prevention of Infection in High-Risk Premature Infants: Report of a Multicenter, Double-Blind Study

PEDIATRICS ◽  
1991 ◽  
Vol 88 (3) ◽  
pp. 437-443
Author(s):  
Jean-François Magny ◽  
Clothilde Bremard-Oury ◽  
Dominique Brault ◽  
Claudie Menguy ◽  
Marcel Voyer ◽  
...  
Keyword(s):  
Placebo Group ◽  
High Risk ◽  
Deleterious Effect ◽  
Controlled Trial ◽  
Immunoglobulin Therapy ◽  
Double Blind Study ◽  
Double Blind ◽  
Intravenous Immunoglobulin Therapy ◽  
Probable Infection ◽  
And Control

The effectiveness of intravenously administered immunoglobulin (Ig) therapy for prophylaxis of infection was evaluated in high-risk preterm infants. Two hundred thirty-five premature newborns were randomly assigned, in a double-blind controlled trial, to treatment and placebo groups. Thirty-five infants (29%) of the Ig group and 29 (25%) of the placebo group had one or more episodes of certain infection. Thirty infants (25%) of the Ig group and 18 (16%) of the placebo group had one or more episodes of probable infection. No significant differences were observed in the incidence of certain or probable infection in treated and control infants. Nevertheless, among the infants who had one or more certain or probable episodes of infection, more of them belonged to the Ig group than to the placebo group. The possible deleterious effect of the administration of large amounts of polyspecific Ig is discussed.

Hemostasis in Patients Undergoing Extracorporeal Circulation: The Effect of Aprotinin (Trasylol)

1991 ◽  
Vol 66 (06) ◽  
pp. 633-637 ◽  
Author(s):  
He Lu ◽  
Claudine Soria ◽  
Pierre-Louis Commin ◽  
Jeannette Soria ◽  
Armand Piwnica ◽  
...  
Keyword(s):  
Placebo Group ◽  
Blood Coagulation ◽  
Extracorporeal Circulation ◽  
Degradation Products ◽  
Artery Bypass ◽  
Platelet Glycoprotein ◽  
Control Group ◽  
High Dose ◽  
Double Blind Study ◽  
Double Blind

SummaryThe administration of aprotinin during extracorporeal circulation (ECC) reduces blood loss. To explore the mechanism of this effect, a placebo-controlled double-blind study was performed in 20 patients (10 were administered with a high dose of aprotinin, 10 with placebo) undergoing a primary, elective operation of coronary artery bypass grafting (CABG) with ECC. Biological tests were performed at 4 different time points during the operation.A marked reduction in the placebo group of ristocetin-induced platelet agglutination (binding of von Willebrand factor [vWF] to platelet glycoprotein [GP] Ib) was shown during ECC and at the end of surgery, but not in the aprotinin group. This abnormality is not related to the hydrolysis of vWF or GP Ib, since washed platelets were resuspended in pooled normal plasma which provided a constant amount of vWF in this test and since the plasma concentration of the fragment of GP Ib (glycocalicin) did not correlate with this abnormality.Despite a high concentration of heparin (5-7 IU/ml) in patient's plasma during bypass, activation of blood coagulation in both groups was evidenced by an increase in ATm (thrombin-modified antithrombin III) level. The level of ATm in the placebo group reached a maximum at the end of ECC during rewarming, while in the aprotinin group, ATm level at this time point was significantly lower than in the control group. In comparison to the placebo group, the generation of the fibrin degradation products (DDE complexes) was inhibited by aprotinin during ECC, but the level of DDE complexes in the aprotinin group was slightly elevated after ECC, although much less than in the placebo group. Other parameters measured did not show significant differences between the two groups.These results indicate that the hemostatic defect in patients during and after ECC may result, at least in part, from the impairment of GP Ib-dependent platelet adhesion. Therefore, the administration of aprotinin in ECC may improve hemostasis by abrogating this impairment, in addition to the protective effect of aprotinin on hemostatic plug. Activation of blood coagulation occurs during cardiopulmonary bypass despite heparin therapy and this activation seems to be partially inhibited by aprotinin administration.

Possible Intraoperative Anesthetic-Sparing Effect of Parenteral Ketorolac

1992 ◽  
Vol 26 (7-8) ◽  
pp. 922-924 ◽  
Author(s):  
Jeffrey T. Moss ◽  
Curtis L. Baysinger ◽  
Garry W. Boswell ◽  
Samual Sayson
Keyword(s):  
Medical Center ◽  
Antiinflammatory Drug ◽  
Control Group ◽  
Narcotic Analgesics ◽  
Double Blind ◽  
Time Curve ◽  
Convenience Sample ◽  
Analgesic Effects ◽  
American Society ◽  
End Tidal

OBJECTIVE: Because the analgesic effects of ketorolac are equivalent to those of narcotic analgesics, we investigated the possibility that this non-steroidal antiinflammatory drug might also exhibit anesthetic-sparing properties similar to those described for narcotic agents. DESIGN: A nonrandomized, double-blind convenience sample. The treatment group received a preoperative dose of ketorolac 60 mg im 45 minutes prior to the induction of anesthesia. All other preoperative medications were identical. SETTING: Brooke Army Medical Center, a primary care setting. PARTICIPANTS: Six women requiring vaginal hysterectomies from American Society of Anesthesiologists class I/II, all of similar age, weight, and body surface area. OUTCOME MEASURES: End-tidal concentrations of the anesthetic gas were measured at five-minute intervals using a gas analyzer. A mean percent end-tidal concentration versus time curve was generated for each group. RESULTS: The area under the concentration curves for the anesthetic gas in the ketorolac and control group were 15.9 ± 5.1 and 52.3 ± 13.4, respectively (p=0.006). CONCLUSIONS: Ketorolac exhibits an anesthetic-sparing quality similar to that observed with narcotic analgesics.

Analgesic Effects of Gabapentin after Spinal Surgery

2004 ◽  
Vol 100 (4) ◽  
pp. 935-938 ◽  
Author(s):  
Alparslan Turan ◽  
Beyhan Karamanlıoğlu ◽  
Dilek Memiş ◽  
Mustafa Kemal Hamamcıoglu ◽  
Barış Tükenmez ◽  
...  
Keyword(s):  
Placebo Group ◽  
Side Effects ◽  
Spinal Surgery ◽  
Early Postoperative Period ◽  
Morphine Consumption ◽  
Control Group ◽  
Double Blind Study ◽  
Double Blind ◽  
Pain Scores ◽  
Incremental Dose

Background A combination of opioid and nonopioid analgesic drugs may improve the quality of postoperative analgesia as well as reduce opioid requirements and their associated side effects. Studies have shown synergism between gabapentin and morphine in animal and human experiments and in the treatment of incisional pain. Therefore, the authors investigated, in a randomized, placebo-controlled, double-blind study, the effects of gabapentin on acute postoperative pain and morphine consumption in patients undergoing spinal surgery. Methods After standard premedication, 25 patients in the control group received oral placebo, and 25 patients in the gabapentin group received 1,200 mg of gabapentin, 1 h before surgery in a randomized fashion. Anesthesia was induced with propofol and cisatracurium and was maintained with sevoflurane and remifentanil. The total intraoperative remifentanil consumption by each patient was noted. All patients postoperatively received patient-controlled analgesia with morphine (1 mg/ml) with an incremental dose of 2 mg, a lockout interval of 10 min, and a 4-h limit of 40 mg. The incremental dose was increased to 3 mg, and the 4-h limit to 50 mg, if analgesia was inadequate after 1 h. Patients were questioned for the first 1 h in the PACU and were later evaluated in the ward at 1, 2, 4, 6, 12, and 24 h. Pain scores, heart rate, oxygen saturation measured by pulse oximetry, mean blood pressure, respiratory rate, sedation, morphine use, and total dose of morphine were recorded. Results Overall, pain scores at 1, 2, and 4 h were significantly lower in the gabapentin group when compared with the placebo group. Total morphine consumption in the gabapentin group was 16.3 +/- 8.9 mg (mean +/- SD) versus 42.8 +/- 10.9 mg in the placebo patients. The incidence of vomiting and urinary retention was significantly (P &lt; 0.05) higher in the placebo group, but there was no difference in incidence of other adverse effects between the groups. Conclusions Preoperative oral gabapentin decreased pain scores in the early postoperative period and postoperative morphine consumption in spinal surgery patients while decreasing some morphine-associated side effects.

Differential analgesic effects of subanesthetic concentrations of lidocaine on spontaneous and evoked pain in human painful neuroma: A randomized, double blind study

2015 ◽  
Vol 8 (1) ◽  
pp. 37-44 ◽  
Author(s):  
Adriana Miclescu ◽  
Martin Schmelz ◽  
Torsten Gordh
Keyword(s):  
Neuropathic Pain ◽  
Nerve Injury ◽  
Control Level ◽  
Sensory Loss ◽  
Control Group ◽  
Spontaneous Pain ◽  
Double Blind Study ◽  
Post Injection ◽  
Double Blind ◽  
Analgesic Effects

AbstractBackgroundBoth peripheral nerve injury and neuroma pain are the result of changes in sodium channel expression. Lidocaine selectively inhibits the spontaneous ectopic activity by binding to sodium channels. Subanesthetics concentrations of lidocaine are able to produce a differential block of the ectopic discharges, but not propagation of impulses, suppressing differentially the associated neuropathic pain symptoms. The aim of this study was to investigate the differences between the analgesic effects of lidocaine 0.5% and a control group of lidocaine 0.1% on several neuroma related pain modalities.MethodsSixteen patients with neuropathic pain due to painful neuromas caused by nerve injury participated in this randomized, double-blind experiment. The patterns of sensory changes were compared before and after injection of 1ml lidocaine 0.5% and 0.1% close to the neuroma, the sessions being 1–2 weeks apart. Spontaneous and evoked pains were assessed using a visual analogue scale (VAS), quantitative and qualitative sensory testing. The primary end-point measure was defined as the change in pain score measured from baseline until 60min after injection. Assessments of spontaneous pain and evoked pain were done post injection at 15s, 30s, 1min, and at 5-min intervals for the first 30-min post injection and then every 10-min to 1 hr post injection. The assessments of pain were performed between the limbs in the following order: spontaneous pain, then assessment of dynamic mechanical allodynia and then hyperalgesia.ResultsLidocaine dose-dependently reduced spontaneous and evoked pain scores by more than 80% with maximum effects between 1 and 5min for evoked pain and between 3 and 15min for spontaneous pain. While evoked pain normalized rapidly reaching about 50% of the control level 20min after the injection, spontaneous pain levels continue to be lower in comparison with baseline values for more than 60min. When comparing the time course of analgesia between spontaneous and evoked pain, lidocaine-induced a greater reduction of evoked pain, but with shorter duration than spontaneous pain. The differences between evoked pain and spontaneous pain were statistically significant in both groups (lidocaine 0.5% group; p = 0.02 and lidocaine 0.1% group; p = 0.01). Reproducibility was high for all assessed variables. Surprisingly, both lidocaine concentrations produced a sensory loss within the area with hyperalgesia and allodynia: hypoesthesia occurred earlier and lasted longer with lidocaine 0.5% (between 30s and 5min) in comparison with lidocaine 0.1% (p = 0.018).ConclusionDifferential analgesic effects of subanesthetic concentrations of local lidocaineon evoked and spontaneous pain in human neuroma suggest that different mechanisms underlie these two key clinical symptoms. Spontaneous pain and evoked pain need an ongoing peripheral drive and any possible CNS amplification change is temporally closely related to this peripheral input.ImplicationsPainful neuroma represents a clinical model of peripheral neuropathic pain that could lead to a significant step forward in the understanding of pain pathophysiology providing the opportunity to study spontaneous and evoked pain and the underlying mechanisms of neuropathic pain. The proposed model of neuropathic pain allows testing new substances by administration of analgesics directly where the pain is generated.

scholarly journals Effects and Safety of Gyejibongnyeong-Hwan on Dysmenorrhea Caused by Blood Stagnation: A Randomized Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
Jeong-Su Park ◽  
Sunju Park ◽  
Chun-Hoo Cheon ◽  
Seong-Cheon Jo ◽  
Han Baek Cho ◽  
...  
Keyword(s):  
Placebo Group ◽  
Controlled Trial ◽  
Control Group ◽  
Menstrual Pain ◽  
Double Blind ◽  
Menstrual Cycles ◽  
Intention To Treat ◽  
Investigational Drugs ◽  
Significant Difference ◽  
Vas Scores

Objective. This study was a multicenter, randomized, double-blind, and controlled trial with two parallel arms: the GJBNH group and the placebo group. This trial recruited 100 women aging 18 to 35 years with primary dysmenorrhea caused by blood stagnation. The investigational drugs, GJBNH or placebo, were administered for two menstrual periods (8 weeks) to the participants three times per day. The participants were followed up for two menstrual cycles after the administration.Results. The results were analyzed by the intention-to-treat (ITT) dataset and the per-protocol (PP) dataset. In the ITT dataset, the change of the average menstrual pain VAS score in the GJBNH group was statistically significantly lower than that in the control group. Significant difference was not observed in the SF-MPQ score change between the GJBNH group and the placebo group. No significant difference was observed in the PP analyses. In the follow-up phase, the VAS scores of the average menstrual pain and the maximum menstrual pain continually decreased in the placebo group, but they increased in the GJBNH group.Conclusion. GJBNH treatment for eight weeks improved the pain of the dysmenorrhea caused by blood stagnation, but it should be successively administered for more than two menstrual cycles.Trial Registration. This trial is registered with Current Controlled Trials no.ISRCTN30426947.

Effects of Astaxanthin Supplementation on Lipid Peroxidation

2007 ◽  
Vol 77 (1) ◽  
pp. 3-11 ◽  
Author(s):  
Karppi ◽  
Rissanen ◽  
Nyyssönen ◽  
Kaikkonen ◽  
Olsson ◽  
...  
Keyword(s):  
Lipid Peroxidation ◽  
Fatty Acids ◽  
Placebo Group ◽  
Intervention Group ◽  
Control Group ◽  
Double Blind Study ◽  
Carotenoid Pigment ◽  
Double Blind

Astaxanthin, the main carotenoid pigment in aquatic animals, has greater antioxidant activity in vitro (protecting against lipid peroxidation) and a more polar configuration than other carotenoids. We investigated the effect of three-month astaxanthin supplementation on lipid peroxidation in healthy non-smoking Finnish men, aged 19–33 years by using a randomized double-blind study design. Also absorption of astaxanthin from capsules into bloodstream and its safety were evaluated. The intervention group received two 4-mg astaxanthin (Astaxin®) capsules daily, and the control group two identical-looking placebo capsules. Astaxanthin supplementation elevated plasma astaxanthin levels to 0.032 μmol/L (p < 0.001 for the change compared with the placebo group). We observed that levels of plasma 12- and 15-hydroxy fatty acids were reduced statistically significantly in the astaxanthin group (p = 0.048 and p = 0.047 respectively) during supplementation, but not in the placebo group and the change of 15-hydroxy fatty acid was almost significantly greater (p = 0.056) in the astaxanthin group, as compared with the placebo group. The present study suggests that intestinal absorption of astaxanthin delivered as capsules is adequate, and well tolerated. Supplementation with astaxanthin may decrease in vivo oxidation of fatty acids in healthy men.

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