Comparison of the effectiveness of circumferential versus non-circumferential spread in median and ulnar nerve blocks. A double-blind randomized clinical trial

2020 ◽  
Vol 45 (5) ◽  
pp. 362-366
Author(s):  
Paula Dieguez-Garcia ◽  
Servando Lopez-Alvarez ◽  
Jorge Juncal ◽  
Ana M Lopez ◽  
Xavier Sala-Blanch
Keyword(s):  
Median Nerve ◽  
Ulnar Nerve ◽  
Motor Block ◽  
Primary Outcome ◽  
Sensory Block ◽  
Nerve Blocks ◽  
Double Blind ◽  
Registration Number ◽  
Tunnel Syndrome ◽  
To Receive

Background and objectivesCircumferential (C) spread of local anesthetic around the nerve is recommended for a successful nerve block. We tested the hypothesis that C spread produces a more complete block than non-circumferential (NC) spread.MethodsWe randomized 124 patients undergoing open carpal tunnel syndrome surgery to receive C or NC spread ultrasound-guided median and ulnar nerve blocks. The primary outcome was the proportion of patients who developed complete sensory block measured at 5, 15 and 30 min. The loss of cold sensation was graded as: 0 (complete block), 1 (incomplete block), or 2 (no block). Secondary outcomes included motor block, nerve swelling and adverse events.ResultsIn group C, complete sensory block at 5 min was 2.4 (95% CI 1.0 to 5.7; p=0.04) times more frequent in the median nerve and 3.0 (95% CI 1.2 to 7.2; p=0.01) times more frequent in the ulnar nerve compared with group C. However, at 15 and 30 min, it was similar between groups. Complete motor block was more frequent in group C than in group NC for both the median nerve: 1.5 (95% CI 1.1 to 2.2; p<0.01) at 15 min, 1.1 (95% CI 1.0 to 1.2; p=0.02) at 30 min, and the ulnar nerve: 1.7 (95% CI 1.2 to 2.6; p<0.01) at 15 min, 1.2 (95% CI 1.0 to 1.4; p<0.01) at 30 min. The incidence of nerve swelling and adverse effects was similar between groups.ConclusionsC spread around the median and ulnar nerves at the level of the antecubital fossa generates more complete sensory and motor blocks compared with NC spread.Trial registration numberEudraCT 2011-002608-34 and NCT01603680

scholarly journals Efficacy of Chlorhexidine Varnish for the Prevention of Adult Caries

2011 ◽  
Vol 91 (2) ◽  
pp. 150-155 ◽  
Author(s):  
A.S. Papas ◽  
W.M. Vollmer ◽  
C.M. Gullion ◽  
J. Bader ◽  
R. Laws ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Tooth Surface ◽  
Placebo Control ◽  
Double Blind ◽  
Intention To Treat ◽  
Significant Difference ◽  
Registration Number ◽  
Secondary Outcomes ◽  
Study Participants ◽  
To Receive

The Prevention of Adult Caries Study, an NIDCR-funded multicenter, double-blind, randomized clinical trial, enrolled 983 adults (aged 18-80 yrs) at high risk for developing caries (20 or more intact teeth and 2 or more lesions at screening) to test the efficacy of a chlorhexidine diacetate 10% weight per volume (w/v) dental coating (CHX). We excluded participants for whom the study treatment was contraindicated or whose health might affect outcomes or ability to complete the study. Participants were randomly assigned to receive either the CHX coating (n = 490) or a placebo control (n = 493). Coatings were applied weekly for 4 weeks and a fifth time 6 months later. The primary outcome (total net D1-2FS increment) was the sum of weighted counts of changes in tooth surface status over 13 months. We observed no significant difference between the two treatment arms in either the intention-to-treat or per-protocol analyses. Analysis of 3 protocol-specified secondary outcomes produced similar findings. This trial failed to find that 10% (w/v) chlorhexidine diacetate coating was superior to placebo coating for the prevention of new caries ( Clinicaltrials.gov registration number NCT00357877).

scholarly journals Systemic dexmedetomidine is not as efficient as perineural dexmedetomidine in prolonging an ulnar nerve block

2019 ◽  
Vol 44 (3) ◽  
pp. 333-340 ◽  
Author(s):  
Jakob Hessel Andersen ◽  
Pia Jaeger ◽  
Ulrik Grevstad ◽  
Stine Estrup ◽  
Anja Geisler ◽  
...  
Keyword(s):  
Ulnar Nerve ◽  
Nerve Block ◽  
Primary Outcome ◽  
Onset Time ◽  
Sensory Block ◽  
Primary Outcome Measure ◽  
Subsequent Treatment ◽  
Systemic Treatments ◽  
Registration Number ◽  
The Difference

BackgroundWe tested the joint hypotheses that both perineural and systemic dexmedetomidine prolong the duration of an ulnar nerve block (UNB) compared with ropivacaine alone and that systemic dexmedetomidine is noninferior compared with perineural dexmedetomidine in block prolongation.MethodsWe performed bilateral UNBs in 22 healthy volunteers on two separate days. On the first day, each arm was randomized to either 4 mL ropivacaine 5 mg/mL+1 mL dexmedetomidine 100 µg/mL (Perineural) or 4 mL ropivacaine 5 mg/mL+1 mL saline (Systemic). On the subsequent treatment day, each arm was randomized to 1 mL of saline plus 4 mL of ropivacaine at either 7.5 mg/mL(HiRopi) or 5 mg/mL (NoDex). The primary outcome measure was the duration of sensory block assessed by mechanical discrimination.ResultsMean sensory block duration was longer in both the Perineural (14.4 hours, 95% CI 13.1 to 15.6) and Systemic treatments (9.2 hours, 95% CI 8.6 to 9.8) compared with the NoDex treatment (7.1 hours, 95% CI 6.6 to 7.6) (p<0.0001 for both). Systemic dexmedetomidine was inferior (not noninferior) compared with perineural dexmedetomidine, as the 95% CI of the difference (mean difference 5.2 hour, 95% CI 4.2 to 6.1) exceeded the noninferiority limit of 3.6 hour. Onset time did not differ among the groups. The other test modalities demonstrated similar block durations as the primary outcome.ConclusionsAdding dexmedetomidine perineurally to ropivacaine doubles the duration of an UNB. Systemic dexmedetomidine also prolongs the duration of UNB, but has less of an effect compared with the perineural route.Trial registration numberNCT03222323.

scholarly journals Effects of addition of Magnesium sulphate to heavy Bupivacaine for spinal anesthesia in vaginal hysterectomy

2014 ◽  
Vol 2 (2) ◽  
pp. 63-68
Author(s):  
Sushila Tabdar ◽  
Uzma Shrestha ◽  
Ekraj Kadariya
Keyword(s):  
Spinal Anesthesia ◽  
Spinal Anaesthesia ◽  
Magnesium Sulphate ◽  
Vaginal Hysterectomy ◽  
Motor Block ◽  
Sensory Block ◽  
P Value ◽  
Double Blind ◽  
Medical College ◽  
To Receive

Background: Adequate pain management is essential for every patient to recover and return to their normal activity quickly. Central sensitization is one of the mechanism which increases excitability of spinal neurons and results persistent pain postoperatively. Objectives: The aim of the study was to investigate the effects of addition of 100 mg 50% Magnesium Sulphate intrathecally to 0.5% heavy Bupivacaine on sensory onset up to T4 level, complete motor block, post-operative analgesia and complications in patients planned for vaginal hysterectomy under spinal anesthesia. Methods: The design of the study was prospective randomized and double blind. With the Institutional improvements and informed consent in Kathmandu Medical College from January 2011 till December 2012, 60 American society of Anesthesiologist class (I, II) patients of age between (40 to 70) years, weight between (45 to 70) kg and height between (4.8 to 5.2) feet undergoing routine vaginal hysterectomy not exceeding one and half hour in spinal anaesthesia were included in the study. The exclusion criteria were patients not following above criteria, having coagulopathy, renal function derangements, uncontrolled hypertension or severe hypotension and having dysarrhythmias. Total patients were randomized into two groups of thirty each. Group A was allocated to receive four ml 0.5% Bupivacaine +0.25 ml normal saline and group B was allocated to receive four ml 0.5% Bupivacaine + 100 mg of 50% Magnesium Sulphate. The anaesthesiologist who was double blind to the drug preparation performed spinal anaesthesia with either of the drug for the whole study.The recorded parameters were time of onset of sensory block upto T4 level, onset of complete motor block, total duration of analgesia and complications in both the groups. Data analysis was done by Computer software polystat XLS using Student’s “t” test. P value <0.05 was considered statistically significant.  Result: The addition of 100 mg of 50% Magnesium sulphate to 0.5% Bupivacaine intrathecally resulted early onset of sensory block upto T4 level in (Mean± SD) (3.79 ± 0.25) min Vs (9.61 ± 0.75) min with sole 0.5% Bupivacaine where p value was < 0.05. Similarly onset of complete motor block with 0.5% Bupivacaine plus Magnesium Sulphate was (1.9 ± 0.23) min verses (10.4 ± 0.63) min with 0.5 % Bupivacaine only. Here again p value was < 0.05. Duration of analgesia with 0.5 % Bupivacaine plus Magnesium Sulphate was (176.8 ± 19. 85) min than that of 0.5% Bupivacaine (105 ± 26.82) min with P value< 0.05. Conclusion: The study concluded that onset as well as analgesic effect of 0.5% Bupivacaine was potentiated by intrathecal Magnesium Sulphate without major side effects.DOI: http://dx.doi.org/10.3126/jkmc.v2i2.10628Journal of Kathmandu Medical College, Vol. 2, No. 2, Issue 4, Apr.-Jun., 2013, Page: 63-68

scholarly journals Hypotension in Preterm Infants (HIP) randomised trial

2021 ◽  
pp. fetalneonatal-2020-320241
Author(s):  
Eugene M Dempsey ◽  
Keith J Barrington ◽  
Neil Marlow ◽  
Colm Patrick Finbarr O'Donnell ◽  
Jan Miletin ◽  
...  
Keyword(s):  
Brain Injury ◽  
Primary Outcome ◽  
Randomised Trial ◽  
Intraventricular Haemorrhage ◽  
Standard Group ◽  
Double Blind ◽  
Group Assignment ◽  
Standard Management ◽  
Postmenstrual Age ◽  
Registration Number

ObjectiveTo determine whether restricting the use of inotrope after diagnosis of low blood pressure (BP) in the first 72 hours of life affects survival without significant brain injury at 36 weeks of postmenstrual age (PMA) in infants born before 28 weeks of gestation.DesignDouble-blind, placebo-controlled randomised trial. Caregivers were masked to group assignment.Setting10 sites across Europe and Canada.ParticipantsInfants born before 28 weeks of gestation were eligible if they had an invasive mean BP less than their gestational age that persisted for ≥15 min in the first 72 hours of life and a cerebral ultrasound free of significant (≥ grade 3) intraventricular haemorrhage.InterventionParticipants were randomly assigned to saline bolus followed by either a dopamine infusion (standard management) or placebo (5% dextrose) infusion (restrictive management).Primary outcomeSurvival to 36 weeks of PMA without severe brain injury.ResultsThe trial terminated early due to significant enrolment issues (7.7% of planned recruitment). 58 infants were enrolled between February 2015 and September 2017. The two groups were well matched for baseline variables. In the standard group, 18/29 (62%) achieved the primary outcome compared with 20/29 (69%) in the restrictive group (p=0.58). Additional treatments for low BP were used less frequently in the standard arm (11/29 (38%) vs 19/29 (66%), p=0.038).ConclusionThough this study lacked power, we did not detect major differences in clinical outcomes between standard or restrictive approach to treatment. These results will inform future studies in this area.Trial registration numberNCT01482559, EudraCT 2010-023988-17.

scholarly journals Comparison of 0.5% Ropivacaine and 0.5% Bupivacaine in Lumbar Epidural Anaesthesia for Lower Limb Orthopaedic Surgery

1997 ◽  
Vol 25 (3) ◽  
pp. 262-266 ◽  
Author(s):  
D. P. McGlade ◽  
M. V. Kalpokas ◽  
P. H. Mooney ◽  
M. R. Buckland ◽  
S. K. Vallipuram ◽  
...  
Keyword(s):  
Lower Limb ◽  
Orthopaedic Surgery ◽  
Motor Block ◽  
Onset Time ◽  
Sensory Block ◽  
Pressure Profile ◽  
Technical Failure ◽  
Time Duration ◽  
Double Blind ◽  
Multi Centre Study

The purpose of this study was to compare the epidural use of 0.5% ropivacaine and 0.5% bupivacaine in patients undergoing lower limb orthopaedic surgery. In a double-blind, randomized, multi-centre study involving 67 patients, thirty-two patients received 20 ml of 0.5% ropivacaine and 35 patients received 20 ml of 0.5% bupivacaine at the L2,3 or L3,4 interspace. Parameters measured were the onset time, duration and spread of sensory block, the onset time, duration and degree of motor block, the quality of anaesthesia and the heart rate and blood pressure profile during block onset. Four patients (3 ropivacaine, 1 bupivacaine) were excluded from the study due to technical failure of the block. The onset and duration of analgesia at the T10 dermatome (median, interquartile range) was 10 (5-15) minutes and 3.5 (2.7-4.3) hours respectively for ropivacaine, and was 10 (6-15) minutes and 3.4 (2.5-3.8) hours respectively for bupivacaine. Maximum block height (median, range) was T6 (T2-T12) for ropivacaine and T6 (C7-T10) for bupivacaine. Nine patients receiving ropivacaine and eight patients receiving bupivacaine developed no apparent motor block. The incidence of complete motor block (Bromage grade 3) was low in both groups, being 4/27 for ropivacaine and 6/34 for bupivacaine. In the ropivacaine group, motor and sensory block were judged to be satisfactory in 78% of patients. In the bupivacaine group, motor and sensory block were judged to be satisfactory in 71% and 62% of patients respectively. Cardiovascular changes were similar in both groups. No statistical differences were found between the two groups regarding any of the study parameters.

scholarly journals Efficacy of Low Dose Levobupivacaine (0.1%) for Axillary Plexus Block using Multiple Nerve Stimulation

2008 ◽  
Vol 36 (6) ◽  
pp. 850-854 ◽  
Author(s):  
X. Zhao ◽  
Y.-W. Wang ◽  
H. Chen ◽  
Z. Zhang ◽  
X.-M. You ◽  
...  
Keyword(s):  
Brachial Plexus ◽  
Motor Block ◽  
Hand Surgery ◽  
Sensory Block ◽  
Sensory Blockade ◽  
Significant Difference ◽  
Brachial Plexus Blockade ◽  
Plexus Block ◽  
To Receive ◽  
Higher Doses

The purpose of this study was to investigate if low doses of levobupivacaine (0.1%) produce complete sensory blockade in preoperative axillary brachial plexus block and to compare the effect of different doses of levobupivacaine on sensory and motor blockade. A total of 110 patients scheduled for elective forearm or hand surgery were randomly allocated to receive 36 ml or 72 ml of levobupivacaine 0.1% or 36 ml of levobupivacaine 0.25%. In each group, volumes were equally distributed in the four nerve territories. In all patients, the sensory and motor block was assessed at five, 10, 20 and 30 minutes after the placement of axillary block. Complete sensory block was obtained in 94.4% of patients receiving 36 ml of levobupivacaine 0.1%, 92.1% of those receiving 72 ml of levobupivacaine 0.1%, and 97.1% of those receiving 36 ml of levobupivacaine 0.25%. There was no significant difference either in the onset of the sensory and motor block or duration of the sensory and motor block. This study demonstrates that 36 ml of levobupivacaine 0.1% (36 mg) is as effective as higher doses and volumes in axillary brachial plexus blockade.

scholarly journals Safety, immunogenicity and efficacy after switching from reference infliximab to biosimilar SB2 compared with continuing reference infliximab and SB2 in patients with rheumatoid arthritis: results of a randomised, double-blind, phase III transition study

2017 ◽  
Vol 77 (2) ◽  
pp. 234-240 ◽  
Author(s):  
Josef S Smolen ◽  
Jung-Yoon Choe ◽  
Nenad Prodanovic ◽  
Jaroslaw Niebrzydowski ◽  
Ivan Staykov ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Transition Period ◽  
Phase Iii ◽  
Double Blind ◽  
Treatment Groups ◽  
American College Of Rheumatology ◽  
Registration Number ◽  
Phase Iii Study ◽  
Transition Study ◽  
To Receive

ObjectivesEfficacy, safety and immunogenicity results from the phase III study of SB2, a biosimilar of reference infliximab (INF), were previously reported through 54 weeks. This transition period compared results in patients with rheumatoid arthritis (RA) who switched from INF to SB2 with those in patients who maintained treatment with INF or SB2.MethodsPatients with moderate to severe RA despite methotrexate treatment were randomised (1:1) to receive SB2 or INF at weeks 0, 2 and 6 and every 8 weeks thereafter until week 46. At week 54, patients previously receiving INF were rerandomised (1:1) to switch to SB2 (INF/SB2 (n=94)) or to continue on INF (INF/INF (n=101)) up to week 70. Patients previously receiving SB2 continued on SB2 (SB2/SB2 (n=201)) up to week 70. Efficacy, safety and immunogenicity were assessed up to week 78.ResultsEfficacy was sustained and comparable across treatment groups. American College of Rheumatology (ACR) 20 responses between weeks 54 and 78 ranged from 63.5% to 72.3% with INF/SB2, 66.3%%–69.4% with INF/INF and 65.6%–68.3% with SB2/SB2. Treatment-emergent adverse events during this time occurred in 36.2%, 35.6% and 40.3%, respectively, and infusion-related reactions in 3.2%, 2.0% and 3.5%. Among patients who were negative for antidrug antibodies (ADA) up to week 54, newly developed ADAs were reported in 14.6%, 14.9% and 14.1% of the INF/SB2, INF/INF and SB2/SB2 groups, respectively.ConclusionsThe efficacy, safety and immunogenicity profiles remained comparable among the INF/SB2, INF/INF and SB2/SB2 groups up to week 78, with no treatment-emergent issues or clinically relevant immunogenicity after switching from INF to SB2.Trial registration numberNCT01936181; EudraCT number: 2012-005733-37.

The effects of concurrent Coenzyme Q10, L-carnitine supplementation in migraine prophylaxis: A randomized, placebo-controlled, double-blind trial

Cephalalgia ◽  
2019 ◽  
Vol 39 (5) ◽  
pp. 648-654 ◽  
Author(s):  
Parisa Hajihashemi ◽  
Gholamreza Askari ◽  
Fariborz Khorvash ◽  
Mohammad Reza Maracy ◽  
Mojgan Nourian
Keyword(s):  
Coenzyme Q10 ◽  
Metabolic Disorders ◽  
Primary Outcome ◽  
Serum Levels ◽  
Parallel Study ◽  
Double Blind ◽  
Beneficial Effects ◽  
Headache Diary ◽  
Combined Supplementation ◽  
To Receive

Purpose The present study aimed to determine the effects of combined supplementation of Coenzyme Q10 with L-carnitine on mitochondrial metabolic disorders marker and migraine symptoms among migraine patients. Methods A total of 56 men and women, between 20–40 years of age with migraine headache, participated in this randomized, double-blind, placebo-controlled, parallel study. The subjects were randomly assigned to receive either 30 mg/day Coenzyme Q10 and 500 mg/day L-carnitine at the same time and/or placebo tablets for 8 weeks. The measurements were completed at the beginning and end of the study. The primary outcome was severity of headache attacks. The secondary outcomes included duration, frequency of headache attacks, the headache diary results (HDR), and serum levels of lactate. Results A significant reduction was obtained in serum levels of lactate (−2.28 mg/dl, 95% CI: −3.65, −0.90; p = 0.002), severity (−3.03, 95% CI: −3.65, −2.40; p ≤ 0.001), duration (−7.67, 95% CI: −11.47, −3.90; p ≤ 0.001), frequency (−5.42, 95% CI: −7.31, −3.53; p ≤ 0.001) and HDR (−103.03, 95% CI: −145.76, −60.29; p ≤ 0.001) after 8 weeks. Conclusion This double-blind parallel study provides evidences supporting the beneficial effects of Coenzyme Q10 and L-carnitine supplements on serum levels of lactate and migraine symptoms. Trial registration IRCT20121216011763N21.

Ulnar and Median Nerve Abnormalities in Carpal Tunnel Syndrome

2020 ◽  
Vol 22 (5) ◽  
pp. 313-322
Author(s):  
Filip Georgiew ◽  
Andrzej Maciejczak ◽  
Jakub Florek ◽  
Ireneusz Kotela
Keyword(s):  
Surgical Treatment ◽  
Carpal Tunnel Syndrome ◽  
Median Nerve ◽  
Ulnar Nerve ◽  
Carpal Tunnel ◽  
Control Group ◽  
Conduction Disturbances ◽  
Tunnel Syndrome ◽  
Sensory Fibers ◽  
American Academy Of Neurology

Background. Nerve compression underlying carpal tunnel syndrome (CTS) results in an increase in the threshold of superficial sensation in the area supplied by the median nerve, which is a mixed nerve dominated by sensory fibres. The distribution of sensory symptoms is strongly dependent on the degree of electrophysiological dysfunction of the median nerve. The association between carpal tunnel syndrome and ulnar nerve entrapment at wrist level is still unclear. Patho­logical processes leading to median neuropathy in CTS may affect ulnar nerve motor and sensory fibers in the Guyon canal. This may explain the extra-median spread of sensory symptoms in CTS patients. Material and methods. The study involved 88 patients (104 hands), with 70 women (83 hands) and 18 men (21 hands) aged between 25 and 77 years. 50 age- and sex-matched subjects without carpal tunnel syndrome were used as a control group. The diagnosis of carpal tunnel syndrome was made according to the criteria of the American Academy of Neurology 1993 guidelines. Based on the results of an ENG trace evaluating the degree of conduction disturbances in the median nerve, the patients were classified to one of three severity subgroups. The threshold of sensory excitability to pulsed current was determined in a test with single 100 ms rectangular pulses. Conclusions. 1. The threshold of sensation in the fingers innervated by the median and ulnar nerve is significantly lon­ger in patients with CTS than in controls. 2. Surgical treatment decreases the threshold of sensation in the fingers innervated by the median nerve. 3. Surgical treatment does not decrease the threshold of sensation in the fingers innervated by the ul­nar nerve. 4. The preoperative and postoperative threshold of sensation in the fingers innervated by the median and ulnar nerve is significantly longer in patients with severe carpal tunnel than in mild and moderate cases.

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