MMC 2015-63 Belladonna and Opium rectal suppository effect ..., Exams of History

Download MMC 2015-63 Belladonna and Opium rectal suppository effect ... and more Exams History in PDF only on Docsity! MMC 2015-63 Belladonna and Opium rectal suppository effect on postoperative pain and nausea following Total Laparoscopic and Robot-Assisted Hysterectomy. 01/18/2017 B&O for TLH Post-operative Pain and Nausea Study Protocol This study is a single-center, double-blind, randomized placebo-controlled trial to assess the impact of immediate postoperative Belladonna and Opium rectal suppository use on postoperative pain and nausea following total laparoscopic and robot-assisted hysterectomy. Study activities to take place at Mercy Medical Center, involving both outpatient and inpatient surgical settings. The duration of the trial will be 12 months, with a goal of enrolling 130 patients during this time period. Patients eligible for trial participation are women between ages 18 and 75 undergoing level I total laparoscopic or robot-assisted hysterectomy with or without bilateral salpingo-oophorectomy, with or without cystoscopy performed post- procedure, with or without lysis of adhesions, and with or without surgical treatment of endometriosis, with no additional surgical procedures being performed (i.e. no lymph node dissection or urogynecologic suspension or sling procedures). Patients will be excluded from the study if they have contraindications to the use of B&O suppositories: these contraindications are glaucoma, severe hepatic or renal disease, bronchial asthma, history of narcotic idiosyncracies, respiratory depression, convulsive disorders, acute alcoholism or delirium tremens, or regular use of an anticholinergic medication (twice per week or more frequently). Patients will be withdrawn from the study if the original planned surgery is not performed. If the original planned study is not performed, a suppository will not be placed following surgery. Patients may also opt to withdraw from the study, or may be withdrawn from the study if there is a failure of the research team to adhere to the study protocol. There will be no financial incentives offered for trial participation. Only the patients of clinical investigators from this trial will be considered for participation in this study. Clinical investigators posting patients for total laparoscopic or robotic hysterectomy at Mercy Medical Center will inform patients of the presence of the clinical trial at the time of surgical posting, using an IRB-approved script (appendix A). The chart number of patients posted for total laparoscopic or robot-assisted hysterectomy will be forwarded to the co- investigator by the clinic surgical coordinator at the time of surgical posting. The co-investigator will review each chart and conduct a telephone interview with each patient prior to surgery to verify trial eligibility and to answer any questions about the trial. Patients will be made aware that study participation is voluntary, and that if they chose to not participate, they will receive standard postoperative pain and nausea pharmacologic management. On the day of surgery, a member of the research team will meet with the patient pre-operatively in a private pre-operative holding area to review and sign a written consent for participation in the trial (Appendix B). This member of the research team would be familiar with the study protocol and risks of the pharmacologic intervention under investigation. These steps will allow patients to be fully informed, and will ensure patient safety and support during the short interval of the study. On the day of surgery, patients will be randomized to either B&O rectal suppository or to a placebo of glycerin rectal suppository. This study employs a glycerin rectal suppository as a placebo because this over-the-counter medication has limited effects, similar to those of a Belladonna & Opium Supprette, and is similar in size, physical appearance and mechanical properties to a Belladonna & Opium Supprette. A placebo-free comparison group will not be used, as this would change the study design from a double-blind clinical trial to a single-blind clinical trial, with greater potential for investigator bias to influence study results. Additionally, Bibliography [1] CEO of Amerifit Brands, Inc., Nov 7, 2007 Gail T. Costello to Cyrill Siewert. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2007/ucm076570.htm. [2] Alexander, Thomas J. Lauterio, and Matthew W. Davis Nasr, "Unapproved drugs in the United States and the Food and Drug Administration," Advances in therapy, vol. 28, no. 10, pp. 842-856, October 2011. [3] Culley CM, Carroll BA, and Skledar SJ, "Formulary decisions for pre-1938 medications," American Journal of Health-System Pharmacy, vol. 65, no. 14, pp. 1363-1367, July 2008. [4] Mary E Kremzner, and Brenda J Kiliany Renu Chhabra, "FDA Policy on Unapproved Drug Products: Past, Present, and Future ," Annals of Pharmacotherapy, vol. 39, no. 7-8, pp. 1260-1264, July 2005. [5] Truven Health Analytics Inc., "Belladonna/Opium," MicroMedex Solutions, July 2014. [6] Lexi-Comp Inc, "Scopolamine (systemic): Drug information," Lexi-Drugs, 2015, Accessed through UpToDate. [7] "Chapter 8 Tropane Alkaloids: Chromatography of Alkaloids - Part B: Gas-Liquid Chromatography and High Performance Liquid Chromatography," Journal of Chromatography Liprary, vol. 23, no. B, pp. 61-72, 1984. [8] (DSB05) Dietary Supplements - Botanicals. U.S. Pharmacopeia. [Online]. www.pharmacopeia.cn/v29240/usp29nf24s0_m7330.html [9] Troedel S, Boquest M, Reeves M Miles PS, "The Pain Visual Analog Scale: Is It Linear or Nonlinear?," Anesthesia & Analgesia, vol. 89, pp. 1517-1520, 1999. [10] Kelly AM, "The minimally clinically significant difference in visual analog scale pain score does not differ with severity of pain," Emergency Medicine Journal, vol. 18, pp. 205-207, 2001. [11] Uccella S, Cromi A, Siesto G, Serati M, Bogani P Ghezzi F, "Postoperative pain after laparoscopic and vaginal hysterectomy for benign disease: a randomized trial," Americal Journal of Obstetrics and Gynecology, vol. 203, no. 2, pp. 118e1-8, 2010. [12] Ball J Whitley E, "Statistics review 4: Sample size calculations," Critical Care, vol. 6, no. 4, pp. 335- 341, 2002. Belladonna and Opium Suppository Study Script “Because you are scheduled to undergo minimally invasive hysterectomy, you may be eligible to participate in a clinical trial that is underway at our institution. The purpose of this trial is to improve our management of post-operative pain and nausea following minimally invasive hysterectomy. The study looks at whether placement of a medicated rectal suppository at the end of surgery (before waking up from anesthesia) results in less post-operative pain and nausea. A study coordinator for this clinical trial will contact you by phone to discuss your possible involvement in the study.” Mercy Medical Center - Research Consent Form Protocol Title: Belladonna and Opium rectal suppository effect on postoperative pain and nausea following Total Laparoscopic and Robot-Assisted Hysterectomy. Principal Investigator: Dr. Kevin Audlin • This is a research study. Participation in this study is entirely voluntary – you may choose to opt out of participation in this study at any point. You may interrupt the consent process to ask questions at any time. PURPOSE OF STUDY • This is a clinical trial to assess whether a Belladonna and Opium rectal suppository placed at the conclusion of laparoscopic or robot-assisted hysterectomy can reduce pain and nausea following surgery. • Belladonna & Opium rectal suppositories are a medication that has been in use for over 75 years. Due to their historic use, the Belladonna & Opium rectal suppository is not an FDA- approved medication, but the FDA allows their use (as is the case for morphine and hydrocodone). Recently, the use of the Belladonna & Opium suppository in the postoperative setting has been studied in men undergoing prostate surgery. • An unmedicated glycerin suppository will be used as a placebo. • You are being asked to participate in this study because you are undergoing laparoscopic/robot-assisted hysterectomy at Mercy Medical Center • There will be 130 women participating in this study. PROCEDURES • Participants in the study will have a single rectal suppository placed at the end of surgery, prior to waking up from anesthesia. • Half of the study participants will receive a Belladonna & Opium rectal suppository. Half of the study participants will receive an unmedicated glycerin suppository. • The treatment you get will be chosen by chance, like flipping a coin. You will have an equal chance of being given each treatment. Neither you nor the study doctor will choose what treatment you get. • The data used in this study is information collected by nurses as part of routine postoperative healthcare. Your participation in the study requires no additional surveys, questions, clinic visits, or telephone calls. Study participation will not extend beyond the duration of your postoperative hospital stay. • There will be no blood draws or other collection of specimens for this study. WHAT ARE MY RESPONSIBILITIES IF I TAKE PART IN THIS RESEARCH? If you take part in this research, you will be responsible for honestly reporting your pain and nausea symptoms to your nurse following surgery up until the time of discharge home from the hospital. conversion to open surgery). If you were to be removed from the research study, you would be informed of this change and you would have a chance to ask questions Signing this consent form indicates that you have read this consent form (or have had it read to you), that your questions have been answered to your satisfaction, and that you voluntarily agree to participate in this research study. You will receive a copy of this signed consent form. If you agree to participate in this study, please sign your name below. Alternatively, you may choose to opt out of this study – in which case do not sign your name below. ___________________________________ Participant’s Signature Date:______________________________ ___________________________________ Investigator or Designee Obtaining Consent Signature Date:_______________________________ Study Participation Alert Form This patient is participating in study protocol MMC 2015-63 Belladonna and Opium Rectal Suppository Effect on Postoperative Pain and Nausea Following Total Laparoscopic and Robot-Assisted Hysterectomy. The Principal Investigator is Dr. Kevin Audlin, his contact number is XXX-XXX- XXXX. The resident study coordinator is Dr. Anna Reinert, her contact number is XXX-XXX-XXXX. The Mercy IRB office contact number is 410-332-9692. This is a randomized, placebo-controlled, double-blinded clinical trial. This patient has received 1 of 2 drugs, placed rectally at the conclusion of surgery. Either: 1. Belladonna & Opium rectal suppository containing 16.2mg of Belladonna plant extract and 60mg of Opium, equivalent to approximately 6mg of morphine. or 2. Glycerin suppository (medically inactive placebo) Neither you, nor the patient will be informed which of the two drugs the patient received. Please treat your patient with routine post-operative care, recognizing that they may have already received the equivalent of 6mg of morphine immediately prior to departure from the OR. Common side effects of B&O suppository are related to anticholinergic activity and include dry nose, mouth, throat, skin, and constipation. Serious side effect are estimated at less than 1% occurrence and include orthostatic hypotension, ventricular fibrillation, tachycardia, palpitation, confusion, drowsiness, headache, loss of memory, fatigue, ataxia, CNS depression, rash, antidiuretic hormone release, bloated feeling, nausea, vomiting, biliary tract spasm, dysuria, urinary retention, urinary tract spasm, increased intraocular pain, blurred vision, weakness, respiratory depression, histamine release, physical and psychological dependence, and diaphoresis. Please notify the GYN resident/fellow if you suspect that your patient is experiencing any of these serious side effects.