• Advantages of mini-laparoscopic vs conventional laparoscopic cholecystectomy: results of a prospective randomized trial

      Novitsky, Yuri W.; Kercher, Kent W.; Czerniach, Donald R.; Kaban, Gordie K.; Khera, Samira; Gallagher-Dorval, Karen A.; Callery, Mark P.; Litwin, Demetrius E. M.; Kelly, John J. (2005-12-21)
      HYPOTHESIS: The use of smaller instruments during laparoscopic cholecystectomy (LC) has been proposed to reduce postoperative pain and improve cosmesis. However, despite several recent trials, the effects of the use of miniaturized instruments for LC are not well established. We hypothesized that LC using miniports (M-LC) is safe and produces less incisional pain and better cosmetic results than LC performed conventionally (C-LC). DESIGN: A patient- and observer-blinded, randomized, prospective clinical trial. SETTING: A tertiary care, university-based hospital. PATIENTS: Seventy-nine patients scheduled for an elective LC who agreed to participate in this trial were randomized to undergo surgery using 1 of the 2 instrument sets. The criteria for exclusion were American Society of Anesthesiologists class III or IV, age older than 70 years, liver or coagulation disorders, previous major abdominal surgical procedures, and acute cholecystitis or acute choledocholithiasis. INTERVENTION: Laparoscopic cholecystectomy performed with either conventional or miniaturized instruments. MAIN OUTCOME MEASURES: Patients' age, sex, operative time, operative blood loss, intraoperative complications, early and late postoperative incisional pain, and cosmetic results. RESULTS: Thirty-three C-LCs and 34 M-LCs were performed and analyzed. There were 8 conversions (24%) to the standard technique in the M-LC group. No intraoperative or major postoperative complications occurred in either group. The average incisional pain score on the first postoperative day was significantly less in the M-LC group (3.9 vs 4.9; P = .04). No significant differences occurred in the mean scores for pain on postoperative days 3, 7, and 28. However, 90% of patients in the M-LC group and only 74% of patients in the C-LC group had no pain (visual analog scale score of 0) at 28 days postoperatively (P = .05). Cosmetic results were superior in the M-LC group according to both the study nurse's and the patients' assessments (38.9 vs 28.9; P<.001, and 38.8 vs 33.4; P = .001, respectively). CONCLUSIONS: Laparoscopic cholecystectomy can be safely performed using 10-mm umbilical, 5-mm epigastric, 2-mm subcostal, and 2-mm lateral ports. The use of mini-laparoscopic techniques resulted in decreased early postoperative incisional pain, avoided late incisional discomfort, and produced superior cosmetic results. Although improved instrument durability and better optics are needed for widespread use of miniport techniques, this approach can be routinely offered to many properly selected patients undergoing elective LC.
    • Analgesic effect of intraarticular bupivacaine or morphine after arthroscopic knee surgery: a randomized, prospective, double-blind study

      Heard, Stephen O.; Edwards, W. Thomas; Ferrari, Dudley; Hanna, Deborah; Wong, Patricia D.; Liland, Astrid; Willock, Marcelle M. (1992-06-01)
      The effect of 20 mL of intraarticular bupivacaine (0.25%, with or without 1:200,000 epinephrine), morphine (0.03%, with or without 1:200,000 epinephrine), or normal saline on postoperative analgesia after arthroscopic knee surgery was studied in a randomized, prospective, double-blind trial in ASA I-III outpatients receiving general anesthesia (n = 112) or regional anesthesia (n = 27 [spinal (n = 25) or epidural (n = 2)]). The visual analogue pain scores in the postanesthesia care unit and 3, 6, 12, and 24 h after surgery, time to first analgesic use, and total 24-h analgesic requirements were recorded. In those who received general anesthesia, the visual analogue scores were significantly lower in the bupivacaine group compared with both the morphine- and placebo-treated patients (P less than 0.05). The time to first analgesic use was longer in both the bupivacaine and morphine groups when compared with the control group (P less than 0.05). No significant differences were detected in total 24-h analgesic requirements among the groups. Patients who had received regional anesthesia had lower visual analogue scores compared with patients who had received general anesthesia irrespective of the intraarticular treatment (P less than 0.05). Our results indicate that intraarticular injection of bupivacaine after arthroscopic knee surgery provides prolonged analgesia but that there is no significant prolonged analgesia provided by intraarticular morphine.
    • Decision Making and the IACUC: Part 1- Protocol Information Discussed at Full-Committee Reviews

      Silverman, Jerald; Lidz, Charles W.; Clayfield, Jonathan C.; Murray, Alexandra; Simon, Lorna J.; Rondeau, Richard G. (2015-07-01)
      IACUC protocols can be reviewed by either the full committee or designated members. Both review methods use the principles of the 3 Rs (reduce, refine, replace) as the overarching paradigm, with federal regulations and policies providing more detailed guidance. The primary goal of this study was to determine the frequency of topics discussed by IACUC during full-committee reviews and whether the topics included those required for consideration by IACUC (for example, pain and distress, number of animals used, availability of alternatives, skill and experience of researchers). We recorded and transcribed 87 protocol discussions undergoing full-committee review at 10 academic institutions. Each transcript was coded to capture the key concepts of the discussion and analyzed for the frequency of the codes mentioned. Pain and distress was the code mentioned most often, followed by the specific procedures performed, the study design, and the completeness of the protocol form. Infrequently mentioned topics were alternatives to animal use or painful or distressful procedures, the importance of the research, and preliminary data. Not all of the topics required to be considered by the IACUC were openly discussed for all protocols, and many of the discussions were limited in their depth.
    • Examining product risk in context. Market withdrawal of zomepirac as a case study.

      Ross-Degnan, Dennis; Soumerai, Stephen B.; Fortess, Eric E.; Gurwitz, Jerry H. (1993-10-27)
      OBJECTIVE--To examine changes in the prescribing of analgesics after the market entry and subsequent withdrawal of zomepirac sodium, a nonsteroidal anti-inflammatory drug (NSAID), following repeated reports of zomepirac-related deaths. DESIGN--To evaluate this natural quasi experiment, we conducted time-series analyses to compare prescribing in two cohorts of primary care physicians from July 1980 through September 1983. SETTING--Study physicians provided outpatient pharmaceutical care to patients enrolled in the New Jersey Medicaid program. PARTICIPANTS--We identified 260 primary care physicians who provided 10 or more prescriptions for zomepirac (zomepirac prescribers) and 308 who provided 10 or more prescriptions for NSAIDs other than zomepirac (other-NSAID prescribers) in Medicaid during the study period. MAIN OUTCOME MEASURES--Monthly rates of prescribing for zomepirac and several categories of substitute analgesics among Medicaid patients seen by study physicians. MAIN RESULTS--Zomepirac accounted for a stable 11.0% of analgesic prescribing among the zomepirac-prescriber cohort; label changes and manufacturer product-risk warnings 11 months before the product's withdrawal from the market had no impact on use. After market entry, zomepirac prescribers reduced use of other NSAIDs and propoxyphene (hydrochloride or napsylate) in comparison with other-NSAID prescribers (-8.1% and -2.8% of total analgesic prescribing, respectively; P < .001). After the product's withdrawal from the market, zomepirac prescribers showed significant increases in relative prescribing of other NSAIDs (+6.8%; P < .001), propoxyphene (+2.1%; P < .05), and analgesics containing barbiturates (+2.7%; P < .001). CONCLUSIONS--The sudden withdrawal of zomepirac from the market resulted in substitutions not only of other NSAIDs, but also of alternative analgesics that carry risks of habituation and adverse effects. Apparent gains in patient safety resulting from market withdrawal of medications must be evaluated in comparison with risks of medications likely to be substituted.
    • Pain assessments and the provision of analgesia: the effects of a templated chart

      Baumann, Brigitte M.; Holmes, John H.; Chansky, Michael E.; Levey, Helen; Kulkarni, Miriam; Boudreaux, Edwin D. (2007-01-14)
      OBJECTIVES: Many emergency departments (EDs) have incorporated pain assessment scales in the medical record to improve compliance with the requirements of the Joint Commission on Accreditation of Healthcare Organizations. The authors conducted a pre-post trial investigating the effects of introducing a templated chart on the documentation of pain assessments and the provision of analgesia to ED patients. METHODS: A total of 2,379 charts were reviewed for inclusion based on the presence of a chief complaint related to trauma or nontraumatic pain, with 1,242 charts included in the analysis. RESULTS: Baseline demographic characteristics, mechanism of injury, location of injury, and initial pain severity were similar in the two groups. The proportion of patients with documentation of pain assessment increased from 41% to 57% (p < 0.001). In particular, traumatic mechanisms and chest, abdominal, and extremity pain yielded the largest improvements in documentation after introduction of the templated charts. Documentation of pain descriptors also improved for time of onset, duration, timing, and context (p < 0.01). Pain control in the templated chart group, however, remained unchanged and the provision of analgesia in the ED was not altered, with the exception of nonsteroidal medications, which decreased from 46% to 36% (p < 0.01). CONCLUSIONS: Although documentation is improved with a templated chart, this improvement did not translate into improved patient care.