scholarly journals Randomized, double-blind, placebo-controlled study of the analgesic effect of intraoperative esmolol for laparoscopic gastroplasty

2019 ◽  
Author(s):  
Vinicius Barros Duarte de Morais ◽  
Rioko Kimiko Sakata ◽  
Ana Paula Santana Huang ◽  
Leonardo Henrique da Cunha Ferraro

Abstract Background Patients undergoing bariatric surgery can have respiratory complications in addition to vomiting and ileus. Esmolol can decrease the consumption of opioids, reducing their side effects. The purpose of this study was to evaluate the analgesic effect of esmolol in patients allocated to laparoscopic gastroplasty. Methods Forty patients between 18 and 50 years old, of both genders, physical status ASA I-II, who underwent bypass gastroplasty were divided into two groups. Participants in group 1 received a 0.5 mg/kg bolus of esmolol in 30 mL of saline before induction of anesthesia, followed by infusion of 15µg/kg/min until the end of surgery; those in group 2 received 30 mL of saline bolus and infusion of solution in the same volume as group 1. The anesthesia included fentanyl (5ug/kg), propofol (2-4 mg/kg), rocuronium (0.6 mg/kg), 50% oxygen without nitrous oxide and 2% sevoflurane, with remifentanil if necessary. There were evaluated: remifentanil consumption, time to analgesic supplementation, pain intensity for 24 h and morphine dose over 24 h. Side effects were noted. Results Intraoperative remifentanil supplementation, time to recovery, and postoperative morphine supplementation were lower in the esmolol group; there was no difference in time for the first supplementation. Pain intensity was lower, except at T0 and after 12 h. There were no differences in side effects. Conclusions Intraoperative esmolol promotes an analgesic effect without causing adverse effects, making it an effective drug for multimodal analgesia for gastroplasty.

2010 ◽  
Vol 1 (2) ◽  
pp. 100-105 ◽  
Author(s):  
Ulrich J. Spreng ◽  
Vegard Dahl ◽  
Johan Ræder

AbstractBackground and objectivePerioperative low-dose ketamine has been useful for postoperative analgesia. In this study we wanted to assess the analgesic effect and possible side-effects of perioperative low-dose S (+) ketamine when added to a regime of non-opioid multimodal pain prophylaxis.MethodsSeventy-seven patients scheduled for haemorrhoidectomy were enrolled in this randomized, double-blind, controlled study. They received oral paracetamol 1–2 g, total intravenous anaesthesia, intravenous 8 mg dexamethasone, 30 mg ketorolac and local infiltration with bupivacaine/epinephrine. Patients randomized to S (+) ketamine received an intravenous bolus dose of 0.35 mg kg−1 S (+) ketamine before start of surgery followed by continuous infusion of 5 μg kg−1 min−1 until 2 min after end of surgery. Patients in the placebo group got isotonic saline (bolus and infusion). BISTM monitoring was used. Pain intensity and side-effects were assessed by blinded nursing staff during PACU stay and by phone 1, 7 and 90 days after surgery.ResultsIn patients randomized to S (+) ketamine emergence from anaesthesia was significantly longer (13.1 min vs. 9.3 min; p < 0.001). BIS values were significantly higher during anaesthesia (maximal value during surgery: 62 vs. 57; p = 0.01) and when opening eyes (81 vs. 70, p < 0.001). Pain scores (NRS and VAS) did not differ significantly between groups.ConclusionsThe addition of perioperative S (+) ketamine for postoperative analgesia after haemorrhoidectomy on top of multimodal non-opioid pain prophylaxis does not seem to be warranted, due to delayed emergence and recovery, more side-effects, altered BIS readings and absence of additive analgesic effect.


2019 ◽  
Vol 11 ◽  
pp. 251584141986185
Author(s):  
Tevfik Ogurel ◽  
Reyhan Ogurel ◽  
Fatma Ozkal ◽  
Yaşar Ölmez ◽  
Nurgül Örnek ◽  
...  

Purpose: To evaluate the analgesic effect of topical 0.1% nepafenac solution during intravitreal Ozurdex injection. Methods: This prospective, randomized, double-blind placebo-controlled study included 59 patients who were diagnosed with retinal vein occlusion or pseudophakic cystoid macular edema and were selected to receive intravitreal Ozurdex injection. The patients were divided into two groups. Group 1, consisting of 31 eyes of 31 patients, received topical 0.1% nepafenac with topical anesthesia (0.5% proparacaine HCl, Alcaine; Alcon, TX, USA), and group 2, consisting of 28 eyes of 28 patients, received placebo with topical anesthesia. Results: There were 14 (45.2%) men and 17 (54.8%) women in group 1 and 16 (57.1%) men and 12 (42.9%) women in group 2. The mean age of the subjects was 64.42 ± 5.51 years in group 1 and 62.32 ± 7.54 years in group 2. The median visual analog scale pain score was 2 (1–3) in group 1 and 4 (1–6) in group 2. The visual analog scale pain score was significantly lower in group 1 than in group 2 ( p < 0.001). Conclusion: Topical 0.1% nepafenac has an additive analgesic effect when combined with topical anesthesia for intravitreal Ozurdex injection.


2012 ◽  
Vol 2012 ◽  
pp. 1-6 ◽  
Author(s):  
Kang-Kon Lee ◽  
Whan-Seok Choi ◽  
Keun-Sang Yum ◽  
Sang-Wook Song ◽  
Sun-Myeong Ock ◽  
...  

Introduction. Fatigue is a common symptom, but only a few effective treatments are available. This study was conducted to assess the efficacy and safety of the human placental extract solution, which has been known to have a fatigue recovery effect.Methods. A total of 315 subjects were randomly assigned to three groups: group 1 (with Unicenta solution administration), group 2 (with exclusively human placental extract administration, excluding other ingredients from the Unicenta solution), and the placebo group. Subsequently, solutions were administered for four weeks.Results. The fatigue recovery rate was 71.00% in group 1, 71.72% in group 2, and 44.21% in the placebo group, which show statistically significant differences between the group 1 and the placebo group (Pvalue = 0.0002), and between group 2 and the placebo group (Pvalue = 0.0001).Conclusion. The human placental extract solution was effective in the improvement of fatigue.


2014 ◽  
Vol 2 (3) ◽  
pp. 9-14
Author(s):  
L Pathak

INTRODUCTION: The role of Gabapentin in relieving chronic pain, chronic anxiety disorders and acute postoperative pain is well known by now. Trials done with the administration of Gabapentin to treat preoperative anxiety showed mixed results. So, this study was conducted to test the hypothesis that premedication with Gabapentin 1200 mg versus placebo would reduce preoperative anxiety in patients undergoing open cholecystectomy under general anesthesia. MATERIAL AND METHODS: A prospective, randomized, double blind and placebo controlled study was carried out at Universal College of Medical Sciences & Teaching Hospital (UCMSTH) from August 2012 to Januray 2014. Total 160 adult patients of American Society of Anaesthesiologist (ASA) I and II were divided into 2 groups of 80 each. Patients in group 1 and group 2 received capsules Gabapentin (1200mg) or identical placebo capsules 2 hours prior to surgery respectively. Preoperative anxiety was assessed for three times using Anxiety Visual Analogue Scale (VAS) score. A uniform anesthetic technique was used in both groups. Parameters including preoperative and postoperative sedation scores and various side effects were also observed.RESULTS: VAS anxiety scores after one hour of drug intake (47.19±17.37 versus 63.13±17.77) and just before induction of anaesthesia (43.81±17.72 versus 81.81±21.57) were significantly lower in Gabapentin group as compared to placebo group. No patient experienced any significant side effects or sedation in either group throughout the study period.CONCLUSIONS: Premedication with 1200 mg Gabapentin in open cholecystectomy patients significantly reduced preoperative anxiety as evident by decrease in anxiety VAS scores without any significant side effects.  DOI: http://dx.doi.org/10.3126/jucms.v2i3.11821 Journal of Universal College of Medical Sciences Vol.2(3) 2014: 9-14


2021 ◽  
Vol 8 (31) ◽  
pp. 2830-2834
Author(s):  
Ranju Sebastian ◽  
Remani Kelan Kamalakshi ◽  
Jamsheena Muthira Parambath ◽  
Praseetha Vallomparambath Kuttiparambil

BACKGROUND Spinal Anaesthesia is the most commonly used form of anaesthesia for surgeries below the level of umbilicus. Bupivacaine is the drug of choice for subarachnoid block. Spinal anaesthesia with bupivacaine is associated with many side effects and complications especially in patients with multiple co-morbid conditions. In our study we compared the anaesthetic effectiveness of 3.5 ml hyperbaric bupivacaine with a mixture of 100 mg ketamine and 0.1 mg adrenaline, the solution is made hyperbaric by adding 1.4 ml of 5 % dextrose given intrathecally. The objective of our study was to compare the anaesthetic properties and clinical effectiveness of intrathecally administered ketamine with bupivacaine for inguinal hernia repair. METHODS This randomised control study was conducted on fifty American society of Anaesthesiologists (ASA) 1 and 2 patients in the age group of 25 – 60 years posted for elective inguinal hernia repair from December 2004 to December 2005. They were randomized in to two groups. Group 1 (Bupivacine group) and Group 2 (Ketamine group). Bupivacaine group (group 1) received 3.5 ml of bupivacaine heavy and ketamine group (group 2) received preservative free ketamine 100 mg with 0.1 mg adrenalin 1/1000 solution in 1.4 ml of 5 % dextrose to make it heavy. Anaesthetic properties, side effects and complications of both groups were compared intraoperatively. RESULTS The onset of action of ketamine (1.58 minutes) was faster than bupivacaine (3.31 minutes) which is statistically significant. Duration of blockade was longer in bupivacaine group (sensory 227.92 and motor 203.08) compared to ketamine group (sensory 143.40 and motor 109.46). Ketamine group showed a greater level of haemodynamic stability than bupivacaine group. CONCLUSIONS Intrathecal ketamine produces optimal anaesthetic conditions for surgeries like inguinal hernia repair. Haemodynamic stability provided by intrathecal ketamine is beneficial in patients with multiple comorbidities. KEYWORDS Hyperbaric Bupivacaine, Ketamine in Hyperbaric Solution, Intrathecal Block, Inguinal Hernia Repair


2020 ◽  
Vol 58 (4) ◽  
pp. 387-394
Author(s):  
A. E. Karateev ◽  
E. Yu. Pogozheva ◽  
E. S. Filatova ◽  
A. M. Lila ◽  
V. N. Amirdjanova ◽  
...  

Diclofenac Potassium sachets (DPS) is a new faster-absorption and rapid onset of pain relief drug dosage form of Diclofenac with high analgesic potential.Objective. To assess efficacy and safety of Diclofenac sachets and intramuscular injections in relieving acute pain in patients with rheumatic diseases (RDs).Materials and methods: The study group included 30 RD patients, 53.3% females and 46.7% males, mean age 41.8 ± 10.7 years, with severe acute pain (≥7 cm VAS pain rating, VAS 0-10 cm). After signing informed consent patients were randomized into DPS 50 mg t.i.d. and Diclofenac 75 mg i/m b.i.d. The first administration of Diclofenac was blind, i.e., patients from both groups were also administered placebo – either placebo injection in Group 1 randomized to sachet or placebo sachet in Group 2. The study lasted for 3 days. Level of analgesia was assessed in 15, 30, 60, 120, 180 minutes after the first administration, then three times a day during two following days and in the morning on day 4. Serum levels of CRP, IL-6 and P substance biomarkers were also monitored.Results. Pain relief in Group 1 was documented already in 15 min after administration – from 8.1±0.8 to 5.7±1.7 cm VAS (р=0.012), with continuing increase of analgesic effect thereafter. Group 2 demonstrated significant pain relief in 1 hour after Diclofenac administration – from 7.6±0.7 to 4.5±1.9 cm VAS (р=0.04). Based on obtained data analgesic effect was more powerful in Group 1 vs Group 2 in 15 and 30 minutes after drug administration (р=0.019; р=0.037). Starting from the 3rd hour post-administration there was no statistically significant difference in pain intensity between the two groups. Final assessment in the morning on day 4 showed significant pain reduction by 4.5±2.6 cm VAS in Group 1 vs baseline, and by 3.6±1.4 cm VAS in Group 2 (p=0.545). Functional improvement in both groups reached 3.7±1.9 and 3.3±1.3 cm VAS, respectively (p=0.837). The results were rated as “good” and “excellent” by 77.0% in Group 1, and 61.5% – in Group 2 (р=0.302). No correlation between decreasing pain intensity and fluctuating CRP, IL-6, and substance P concentrations was established. Three patients from Group 1 reported new-onset dyspepsia, resulting in discontinuation of treatment in 2 of them. Similarly, 2 discontinuations occurred in 2 patients with new-onset dyspepsia in Group 2, plus one additional withdrawal due to gastric ulcer and elevated blood pressure.Conclusion. DPS is not inferior to i/m Diclofenac injections in terms of analgesic potential and rapid onset of pain relief. Oral intake is associated with fewer adverse reactions compared to i/m injections. 


2020 ◽  
Vol 133 (1) ◽  
pp. 154-164 ◽  
Author(s):  
Gisèle Pickering ◽  
Bruno Pereira ◽  
Véronique Morel ◽  
Alexandrine Corriger ◽  
Fatiha Giron ◽  
...  

Background Ketamine is often used for the management of refractory chronic pain. There is, however, a paucity of trials exploring its analgesic effect several weeks after intravenous administration or in association with magnesium. The authors hypothesized that ketamine in neuropathic pain may provide pain relief and cognitive–emotional benefit versus placebo and that a combination with magnesium may have an additive effect for 5 weeks. Methods A randomized, double-blind, crossover, placebo-controlled study (NCT02467517) included 20 patients with neuropathic pain. Each ketamine-naïve patient received one infusion every 35 days in a random order: ketamine (0.5 mg/kg)/placebo or ketamine (0.5 mg/kg)/magnesium sulfate (3g) or placebo/placebo. The primary endpoint was the area under the curve of daily pain intensity for a period of 35 days after infusion. Secondary endpoints included pain (at 7, 15, 21 and 28 days) and health-related, emotional, sleep, and quality of life questionnaires. Results Daily pain intensity was not significantly different between the three groups (n = 20) over 35 days (mean area under the curve = 185 ± 100, 196 ± 92, and 187 ± 90 pain score-days for ketamine, ketamine/magnesium, and placebo, respectively, P = 0.296). The effect size of the main endpoint was −0.2 (95% CI [−0.6 to 0.3]; P = 0.425) for ketamine versus placebo, 0.2 (95% CI [−0.3 to 0.6]; P = 0.445) for placebo versus ketamine/magnesium and -0.4 (95% CI [−0.8 to 0.1]; P = 0.119) for ketamine versus ketamine/magnesium. There were no significant differences in emotional, sleep, and quality of life measures. During placebo, ketamine, and ketamine/magnesium infusions, 10%, 20%, and 35% of patients respectively reported at least one adverse event. Conclusions The results of this trial in neuropathic pain refuted the hypothesis that ketamine provided pain relief at 5 weeks and cognitive–emotional benefit versus placebo and that a combination with magnesium had any additional analgesic effect. Editor’s Perspective What We Already Know about This Topic What This Article Tells Us That Is New


2020 ◽  
Vol 45 (10) ◽  
pp. 805-812
Author(s):  
Philippe Macaire ◽  
Nga Ho ◽  
Vien Nguyen ◽  
Hieu Phan Van ◽  
Kim Dinh Nguyen Thien ◽  
...  

BackgroundPostoperative pain after pediatric cardiac surgery is usually treated with intravenous opioids. Recently, the focus has been on postoperative regional analgesia with the introduction of ultrasound-guided erector spinae plane blocks (ESPBs). We hypothesized that bilateral ESPB with a programmed intermittent bolus (PIB) regimen decreases postoperative morphine consumption at 48 hours and improves analgesia in children who undergo cardiac surgery.MethodsThis randomized, double-blind, placebo-controlled study comprised 50 children who underwent cardiac surgery through midline sternotomy. The patients were allocated randomly into two groups: ultrasound-guided bilateral ESPB at the level of T3–T4 transverse process then PIB with saline infusion (group 1, n=23) or PIB with 0.2% ropivacaine (group 2, n=27). Intravenous morphine at 30 µg/kg/hour was used as rescue analgesia. Postoperative pain was assessed using the COMFORT-B score for extubation, drain removal, and mobilization, and the FLACC (Face, Legs, Activity, Cry, Consolability) scale at 0, 2, 4, 6, 8, 12, 16, 20, 24, 36, and 48 hours after surgery. Adverse events were noted.ResultsThe total dose of morphine in 48 hours was significantly decreased in patients receiving a bilateral ESPB with ropivacaine (120±320 µg/kg) compared with patients with saline infusion (512±560 µg/kg; p=0.03). Fourteen per cent of patients required rescue analgesia with morphine in group 2 compared with 41% in group 1 (p=0.05). The patients in group 2 demonstrated significantly reduced COMFORT-B scores at extubation, drain removal, and mobilization compared with those in group 1 and had reduced FLACC scale levels at 20 and 24 hours postoperatively (p=0.05 and p=0.001, respectively). No differences were reported for extubation and drain removal times or for length of hospital stay. In addition, vomiting episodes were decreased in group 2 (p=0.01).ConclusionsIn pediatric cardiac surgery, the results of this study confirm our hypothesis that bilateral ESPB analgesia with ropivacaine decreases the postoperative morphine consumption at 48 hours and demonstrates better postoperative analgesia compared with a control group.Trial registration numberNCT03593642.


2017 ◽  
Vol 2017 ◽  
pp. 1-7 ◽  
Author(s):  
Aik Bouzia ◽  
Vassilios Tassoudis ◽  
Menelaos Karanikolas ◽  
George Vretzakis ◽  
Argyro Petsiti ◽  
...  

Introduction. Pain after cardiac surgery affects long-term patient wellness. This study investigated the effect of preoperative pregabalin on acute and chronic pain after elective cardiac surgery with median sternotomy. Methods. Prospective double blind study. 93 cardiac surgery patients were randomly assigned into three groups: Group 1 received placebo, Group 2 received oral pregabalin 75 mg, and Group 3 received oral pregabalin 150 mg. Data were collected 8 hours, 24 hours, and 3 months postoperatively. Results. Patients receiving pregabalin required fewer morphine boluses (10 in controls versus 6 in Group 1 versus 4 in Group 2, p=0.000) and had lower pain scores at 8 hours (4 versus 3 versus 3, p=0.001) and 3 months (3 versus 2 versus 2, p=0.000) and lower morphine consumption at 8 hours (14 versus 13 versus 12 mg, p=0.000) and 24 hours (19.5 versus 16 versus 15 mg, p=0.000). Percentage of patients with sleep disturbances or requiring analgesics was lower in the pregabalin group and even lower with higher pregabalin dose (16/31 versus 5/31 versus 3/31, p=0.000, and 26/31 versus 16/31 versus 10/31, p=0.000, resp.) 3 months after surgery. Conclusion. Preoperative oral pregabalin 75 or 150 mg reduces postoperative morphine requirements and acute and chronic pain after cardiac surgery.


2014 ◽  
Vol 11 (3) ◽  
pp. 254-259 ◽  
Author(s):  
L Pathak ◽  
A Chaturvedi

Background: In addition to chronic pain and anxiety disorders, few studies have found promising role of gabapentin in relieving acute postoperative pain as well as acute anxiety too. Objectives: To evaluate the effect of gabapentin premedication on preoperative anxiety and postoperative pain in patients undergoing elective open cholecystectomy. Methods: A prospective, randomized, double blind and placebo controlled study. Eighty adult patients of ASA I and II were divided into 2 groups of 40 each. Patients in group 1 and group 2 received capsules Gabapentin (1200mg) or identical placebo capsules 2 hours prior to surgery respectively. Preoperative anxiety and 12 hours postoperative pain was assessed using Anxiety and Pain VAS score respectively along with the observation of side effects. Postoperatively, intravenous pethidine 0.5 mg/kg was given when pain VAS > 40mm and time to first pethidine injection and total pethidine consumption in 12 hours was recorded. Results: Anxiety VAS scores after one hour of drug intake (35.75±20.11 versus 46.63±12.73) and just before induction of anaesthesia (45.75±30.27versus 68.13±29.84) along with postoperative Pain VAS scores were significantly lower in gabapentin group. Time to the first pethidine demand was significantly longer (145.34±194.54 min versus 26.30±51.02min) and cumulative pethidine consumption throughout study period was also significantly lower (35.91 ± 16.61 versus 57.84 ± 20.72mg) in gabapentin group. Conclusions: 1200 mg gabapentin premedication in open cholecystectomy patients significantly reduced preoperative anxiety, postoperative pain and total pethidine consumption with negligible side effects. DOI: http://dx.doi.org/10.3126/hren.v11i3.9642 Health Renaissance 2013;11(3):254-259


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