scholarly journals Randomized, double-blinded, placebo-controlled trial comparing two multimodal opioid-minimizing pain management regimens following transsphenoidal surgery

2018 ◽  
Vol 128 (2) ◽  
pp. 444-451 ◽  
Author(s):  
Deborah M. Shepherd ◽  
Heidi Jahnke ◽  
William L. White ◽  
Andrew S. Little

OBJECTIVEPain control is an important clinical consideration and quality-of-care metric. No studies have examined postoperative pain control following transsphenoidal surgery for pituitary lesions. The study goals were to 1) report postoperative pain scores following transsphenoidal surgery, 2) determine if multimodal opioid-minimizing pain regimens yielded satisfactory postoperative pain control, and 3) determine if intravenous (IV) ibuprofen improved postoperative pain scores and reduced opioid use compared with placebo.METHODSThis study was a single-center, randomized, double-blinded, placebo-controlled intervention trial involving adult patients with planned transsphenoidal surgery for pituitary tumors randomized into 2 groups. Group 1 patients were treated with scheduled IV ibuprofen, scheduled oral acetaminophen, and rescue opioids. Group 2 patients were treated with IV placebo, scheduled oral acetaminophen, and rescue opioids. The primary end point was patient pain scores (visual analog scale [VAS], rated 0–10) for 48 hours after surgery. The secondary end point was opioid use as estimated by oral morphine equivalents (OMEs).RESULTSOf 136 patients screened, 62 were enrolled (28 in Group 1, 34 in Group 2). The study was terminated early because the primary and secondary end points were reached. Baseline characteristics between groups were well matched except for age (Group 1, 59.3 ± 14.4 years; Group 2, 49.8 ± 16.2 years; p = 0.02). Mean VAS pain scores were significantly different, with a 43% reduction in Group 1 (1.7 ± 2.2) compared with Group 2 (3.0 ± 2.8; p < 0.0001). Opioid use was significantly different, with a 58% reduction in Group 1 (26.3 ± 28.7 mg OME) compared with Group 2 (62.5 ± 63.8 mg OME; p < 0.0001).CONCLUSIONSMultimodal opioid-minimizing pain-management protocols resulted in acceptable pain control following transsphenoidal surgery. IV ibuprofen resulted in significantly improved pain scores and significantly decreased opioid use compared with placebo. Postoperative multimodal pain management, including a nonsteroidal antiinflammatory medication, should be considered after surgery to improve patient comfort and to limit opioid use.Clinical trial registration no.: NCT02351700 (clinicaltrials.gov)■ CLASSIFICATION OF EVIDENCE Type of question: therapeutic; study design: randomized, controlled trial; evidence: Class III.

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e025855 ◽  
Author(s):  
Chad F Claus ◽  
Evan Lytle ◽  
Doris Tong ◽  
Diana Sigler ◽  
Dominick Lago ◽  
...  

IntroductionKetorolac has been shown to provide quality postoperative pain control and decrease opioid requirement with minimal side effects following spinal surgery. However, the literature addressing its use in spinal fusions is highly variable in both its effectiveness and complications, such as pseudarthrosis. Recent literature postulates that ketorolac may not affect fusion rates and large randomised controlled trials are needed to demonstrate ketorolac as a safe and effective adjuvant treatment to opioids for postoperative pain control.Methods and analysisThis is a multihospital, prospective, double-blinded, randomised placebo-controlled trial. Data concerning fusion rates, postoperative opioid use, pain scores, length of stay will be recorded with the aim of demonstrating that the use of ketorolac does not decrease thoracolumbar spinal fusion rates while identifying possible adverse events related to short-term minimal effective dose compared with placebo. Additionally, this investigation aims to demonstrate a decrease in postoperative opioid use demonstrated by a decrease in morphine equivalence while showing equivalent postoperative pain control and decrease the average length of stay.Ethics and disseminationEthical approval was obtained at all participating hospitals by the institutional review board. The results of this study will be submitted for publication in peer-reviewed journals.Trial registration numberNCT03278691.


2020 ◽  
pp. 112070002095024
Author(s):  
Efi Kazum ◽  
Ehud Rath ◽  
Amir Shlaifer ◽  
Zachary T Sharfman ◽  
Hal D Martin ◽  
...  

Introduction: Literature addressing postoperative pain management after hip arthroscopy is relatively scarce. This study aimed to assess if there was added analgesic benefit associated with postoperative intra-articular bupivacaine blockade for patients who received preoperative peri-acetabular blockade for hip arthroscopy procedures. Methods: 52 patients were included in this comparative cohort study. Group 1 consisted of 20 patients who received preoperative peri-acetabular blockade and postoperative intra-articular blockade. The control group (Group 2), consisted of 32 patients who received only preoperative peri-acetabular blockade. Postoperative pain was recorded via visual analogue scale (VAS) pain scores, analgesic consumption, and pain diaries for 2 weeks postoperatively. Results: Postoperative VAS pain scores were significantly lower in the experimental group at the 30-minute recovery room assessment (VAS scores Group 1: 1.1; Group 2: 3.00, p = 0.034). Other than the 30-minute recovery room assessment, VAS pain scores, narcotic medication consumption, and non-narcotic analgesic consumption did not differ between the 2 groups at any time point in the study period. Conclusions: This study did not demonstrate significant clinical benefit for patients who receive postoperative intra-articular blockade in addition to preoperative peri-acetabular blockade with bupivacaine 0.5%. We recommend the use of preoperative peri-acetabular bupivacaine blockade without intra-articular blockade postoperatively for pain control in the setting of hip arthroscopy surgery.


1995 ◽  
Vol 83 (3) ◽  
pp. 470-477. ◽  
Author(s):  
Rafael Miguel ◽  
Joel M. Kreitzer ◽  
Douglas Reinhart ◽  
Peter S. Sebel ◽  
Julius Bowie ◽  
...  

Background A new transdermal delivery system for fentanyl is available in two strengths: 70-80 and 90-100 micrograms.kg-1.h-1 (40- and 60-cm2 patches, respectively). Their short onset and 24-h drug delivery make them attractive for postoperative pain control. Methods Both doses of the new transdermal fentanyl patches were evaluated for the relief of postoperative pain in 143 patients after gynecologic exploratory laparotomy. The study was conducted at four centers using a prospective, randomized, placebo-controlled, double-blind format. Patients were randomly assigned to one of three study groups: group 1 patients received two placebo patches: group 2 patients received a 40-cm2 fentanyl patch and a 60-cm2 placebo patch; and group 3 patients received a 60-cm2 fentanyl patch and a 40-cm2 placebo patch. Patient-controlled morphine use and pain, sedation, and comfort scores were assessed postoperatively every 4 h for 36 h after patch placement. Results Patients' assessment of their analgesia was significantly (P &lt; or = 0.05) better in group 2 at 16 and 24 h and in group 3 at 8, 12, 16, 20, and 24 h postoperatively, compared with the patients in group 1. Patients in groups 2 and 3 required less supplemental morphine to maintain satisfactory analgesia than did the patients in group 1. Patients in groups 2 and 3 had greater incidences of pruritus, erythema, and respiratory depression than did those receiving placebo. Conclusions Concern exists regarding the side effects of this this new transdermal fentanyl patch. Therefore, this new patch will need further research before it can be recommended as an adjunct in controlling postoperative pain.


2011 ◽  
Vol 58 (2) ◽  
pp. 57-60 ◽  
Author(s):  
Joao Paulo Steffens ◽  
Márcia Thaís Pochapski ◽  
Fábio André Santos ◽  
Gibson Luiz Pilatti

Abstract The aim of this study was to evaluate the influence of 2 anesthetic agents on patients' postoperative pain perception after periodontal surgery. For this parallel-group, double-blinded, randomized clinical trial, 36 open flap debridement surgeries were performed on patients who presented with periodontal disease with clinical signs of inflammation after nonsurgical treatment on at least 1 quadrant. Patients were allocated to 1 of the following groups: group 1, 2% lidocaine with 1 ∶ 100,000 epinephrine; group 2, 2% mepivacaine with 1 ∶ 100,000 norepinephrine. Pain intensity was assessed using the visual analog scale during the first 8 hours after surgery. All patients received 750-mg acetaminophen tablets, which they were instructed to take as a rescue medication if necessary. The results demonstrated that postoperative pain intensity was statistically lower in group 2 than in group 1 at the 1-, 2-, and 3-hour periods after surgery, although the pain intensity for all groups could be considered mild. In conclusion, patients in both groups reported similar mild pain after periodontal surgery.


Author(s):  
Hira Abbasi ◽  
Abhishek Lal ◽  
Ammara Shamim Jaffrani

Aims: This study aims to compare the efficacy in alleviating pain between intracanal medicaments, namely Nitrofurantoin and Calcium Hydroxide Paste. Study Design:  Randomized Controlled Trial. Place and Duration of Study: Sample: Department of Operative Dentistry, Sir Syed College of Medical Sciences, Pakistan, between January 2021 and May 2021. Methodology: 60 patients were randomly divided into 3 groups, each group having 20 patients as following: Group 1: Nitrofurantoin, Group 2: Calcium Hydroxide and Group 3: Control. Preoperative pain was recorded using a numerical pain scale. After access preparation, chemomechanical preparation was performed with subsequent placement of intracanal medicaments. Pre-operative pain score was initially recorded, followed by post-operative pain at 12, 24, 48, and 72 hours, respectively. Root canal treatment was performed in single rooted teeth with patients suffering from symptomatic irreversible pulpitis Results: Majority of the patients in all 3 groups were initially presented with moderate to severe pre-operative pain. After 72 hours post-operatively, 50% patients in Group 1 reported no pain, while 5% patients in both Group 2 and 3 had no pain. Pain significantly subsided in Group 1 as compared to Group 2 and 3. Regarding age and gender, both had no significant relationship with the pain scores in all of the 3 groups Conclusion: Nitrofurantoin has been proven to be an effective intracanal medicament in alleviating immediate post-operative pain in patients with symptomatic irreversible pulpitis as compared to calcium hydroxide. While the control group with no intracanal medicament showed little reduction in pain scores. So, nitrofurantoin can be used as a substitute to currently available standard intracanal medicaments.


Author(s):  
Kreijveld BJ ◽  
◽  
Bekkers IPW ◽  
Mulder E ◽  
Wassen MMLH ◽  
...  

Background: Lack of postoperative acute pain management is associated with increased morbidity, longer recovery time, more opioid use and subsequently increased health care costs. There is increasing evidence that Virtual Reality (VR) is effective in the reduction of acute pain. Alternative methods to reduce postoperative pain and multimodal analgesia are necessary for acute postoperative pain management and to reduce opioid use and their adverse effects. The aim of this study is to explore the effect of VR on pain in the postoperative period after elective gynecological surgery. Methods and Design: The study concerns a non-blinded, single center, randomized controlled trial. Eligible women fulfilling the inclusion criteria and receive elective gynecological surgery in the Zuyderland Medical Center will be randomized for participation. The study population will be randomly divided into the intervention group (VR-group) or the standard care- group. The intervention group can choose for an immersive guided relaxation VR experience or an interactive VR experience during the pre- and postoperative period additional to the usual standard care. The participants randomized to the standard caregroup will receive only the usual standard care pre-and postoperative. The primary outcome is postoperative pain measured on a Numeric Rating Scale (NRS). A total of 30 patients have to be included in each group. This means that a total of 60 women will have to be included in this study. Secondary outcomes are; evaluating pre-and postoperative anxiety, pain catastrophizing, analgesic use, length of hospital stay between both groups and to explore tolerability, feasibility and satisfaction of VR use. Discussion: This study will provide insight as to whether in women who receive gynecological surgery, VR is an effective method to reduce postoperative pain and subsequently opioid use.


WCET Journal ◽  
2019 ◽  
Vol 39 (3) ◽  
pp. 26-31
Author(s):  
Fateme Guitynavard ◽  
Shahram Gooran ◽  
Parvin Kasiri ◽  
Farshad Gholipour ◽  
Seyed Mohammad Kazem Aghamir

Objective: To evaluate the effect of tamsulosin on stent-related symptoms in patients undergoing double-J ureteral stenting. Methods: and materials Seventy patients (47 men and 23 women; mean age 42.5 years) who underwent double-J stent placement in adjunct to urological surgery were prospectively randomised into two groups. Group 1 included 35 patients who received 0.4 mg of tamsulosin once daily for 4 weeks; group 2 included 35 patients who received a placebo for the same protocol. All patients were interviewed by the same physician about the frequency of stent-related symptoms at 4 weeks after stent insertion. Results: Patients in group 1 showed a lower score for suprapubic pain during the filling phase and lower pain during sexual activity than group 2, although the overall pain score was not significantly different between two groups. The mean urinary urgency score was less in group 1 in comparison to the placebo group (p=0.030). No statistically significant differences were found between two groups concerning haematuria, urinary incontinence, frequency nor dysuria. Conclusion: Tamsulosin improves symptoms associated with double-J ureteral stents, especially body pain during sexual activity.


2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Aathira Suresh ◽  
Gajanan Fultambkar ◽  
B. Vijayanand ◽  
Abhijit Nair

Abstract Background Total knee arthroplasty (TKA) causes significant postoperative pain, imposing a limitation on postoperative mobilization crucial in regaining joint function. Ultrasound (US)-guided femoral nerve block (FNB) in complex knee surgeries is associated with better pain scores and fewer hospital admissions. Alpha-2 (α2) adrenoreceptor agonists have been the recent focus of interest as additives to local anesthetic. We aimed to compare the equivalent dose of dexmedetomidine and clonidine as an adjuvant to ropivacaine in US-guided FNB in TKA. A prospective, randomized, controlled, double-blinded study was conducted involving 80 American Society of Anesthesiologists’ physical status (ASA-PS) I, II, and III patients scheduled to undergo TKA under subarachnoid block. Group 1 (n = 40) patients received 1 μg/kg dexmedetomidine and group 2 (n = 40) patients with 1 μg/kg clonidine as adjuvants added to 20 ml of 0.75% ropivacaine. Duration of postoperative analgesia, pain scores, sedation scores, hemodynamics, rescue analgesia requirement, complications, and patient satisfaction were compared. Results The total duration of analgesia in group 1 was better compared to group 2 (p < 0.001). The patients were better sedated and the mean NRS scores were significantly lower (p < 0.05) in group 1 up to 24 h postoperatively. Total analgesic consumption was reduced in group 1, with a p value < 0.001. Patient satisfaction was significantly better (p < 0.001) in group 1 compared to group 2. Conclusion We conclude that dexmedetomidine added as an adjuvant in FNB increased the duration of analgesia when compared to clonidine with decreased NRS scores, reduced postoperative tramadol requirement, and better sedation and patient satisfaction. Trial registration Researchregistry6709, “Retrospectively registered” on 31 March 2021.


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