Material & Methods: A parallel design, prospective randomized double masked placebo controlled clinical trial in which hundred patients more than 18 years of age with stable myopia of more than 1.5 diopters were enrolled. Preoperative visual acuity, corneal thickness and detailed slit lamp biomicroscopic examination were done. Patients were instructed to instill one drop of allotted drug (either ascorbic acid or placebo) four times daily along with the routine post LASIK medications for the three consecutive post-operative days. Visual acuity, corneal thickness, slit lamp biomicroscopy for corneal wound and interface, tolerance to drug and relief of pain was assessed on day one and day seven. Results were evaluated by preset questionnaires and comprehensive clinical examination on the day one and day seven. There were no significant differences on day one and day seven in visual acuity, corneal clarity, corneal thickness and corneal wound healing (p>0.05). Ascorbic acid for the first three days postoperatively after LASIK did not show any immediate clinical benefit over placebo.
PURPOSE: We designed a randomized double-blind placebo-controlled trial to assess the role of a single prophylactic dose of vitamin C (2 g) po in reducing the consumption of opioids postoperatively in patients undergoing laparoscopic cholecystectomy.
METHODS: Eighty adult patients were allocated to receive 2 g vitamin C po or placebo approximately one hour prior to induction of anesthesia. Following laparoscopic cholecystectomy, patients received morphine patient-controlled analgesia for 24 hr. The following data were assessed postoperatively in the postanesthesia care unit at two, four, six, 12, and 24 hr: morphine consumption, verbal numerical rating scale scores for incisional pain and nausea/vomiting, and pruritus and sedation scores. The primary outcome measure was 24-hr morphine consumption. Patient satisfaction was assessed before hospital discharge.
RESULTS: Morphine consumption was significantly lower in the vitamin C group vs the placebo group [16.2 (10.7) and 22.8 (13.8) mg, respectively; difference = 6.6 mg; 95% confidence interval, 1.1 to 12.1 mg; P = 0.02]. There was no difference in pain scores or side effects between the two groups. Satisfaction scores were similar in both groups.
CONCLUSION: Our study showed that supplementation with vitamin C (2 g) po decreased morphine consumption in the postoperative period in patients undergoing laparoscopic cholecystectomy.
BACKGROUND: The public health cost impact of complex regional pain syndrome type I (CRPS I) is considerable in both emergency and scheduled orthopaedic surgery. We proposed to assess the effectiveness of vitamin C in prevention of CRPS I in foot and ankle surgery.
METHODS: We carried out a "before-after" quasi-experimental study comparing two chronologically successive groups without (Group I: July 2002-June 2003) and with (Group II: July 2003-June 2004) preventive 1g daily vitamin C treatment. All patients having surgery on the foot or ankle were enrolled, with the exception of diabetic foot cases. Several factors were analysed: sex, age, type of pathology, history of CRPS I, psychological context, tourniquet time, and cast immobilisation time.
RESULTS: 420 feet (392 patients) were included in the study: 185 in Group I, 235 in Group II. CRPS I occurred in 18 cases in Group I (9.6%) and 4 cases in Group II (1.7%) (p<10(-4)), with history of CRPS I as a significantly correlated factor (relative risk=10.4). The psychological context (anxio-depressive state) showed a (sub-significant) tendency to increase the risk of CRPS I (relative risk=2.6).
CONCLUSION: Vitamin C has been shown to be effective in preventing CRPS I secondary to wrist fracture, but few data are available with respect to foot and ankle cases. The present study demonstrates the effectiveness of vitamin C in preventing CRPS I of the foot and ankle-a frequent complication in our control group (9.6%). The authors recommend preventive management by vitamin C.
UNLABELLED: Non-opioid analgesics have become increasingly popular as part of a multimodal regimen for pain management in the ambulatory setting. We designed this randomized, double-blind, placebo-controlled study to evaluate the effect of perioperative administration of the cyclooxygenase-2 inhibitor rofecoxib on patient outcome after inguinal herniorrhaphy procedures. Sixty consenting outpatients undergoing elective hernia repair surgery were randomly assigned to one of two treatment groups: control (vitamin C, 500 mg) or rofecoxib (rofecoxib, 50 mg). The first oral dose of the study medication was administered 30-40 min before entering the operating room, and a second dose of the same medication was given on the morning of the first postoperative day. Recovery times, postoperative pain scores, the need for "rescue" analgesics, and side effects were recorded at 1- to 10-min intervals before discharge from the recovery room. Follow-up evaluations were performed at 36 h, 7 days, and 14 days after surgery to assess postdischarge pain, analgesic requirements, resumption of normal activities, as well as patient satisfaction with their postoperative pain management. Rofecoxib significantly decreased the early recovery times, leading to an earlier discharge home after surgery (88 +/- 30 vs 126 +/- 44 min, P < 0.05). When compared with the control group, the patients' median [range] quality of recovery score was also significantly higher in the rofecoxib group (18 [14-18] vs 16 [13-18], P < 0.05). In the predischarge period, a significantly larger percentage of patients required rescue pain medications in the control group (67% vs 37% in the rofecoxib group, P < 0.05). At the 36-h follow-up assessment, rofecoxib-treated patients reported significantly reduced oral analgesic requirements (0 [0-20] vs 9 [1-33] pills, P < 0.05) and lower maximal pain scores, resulting in improved patient satisfaction with their postoperative pain management (3 [1-4] vs 2 [0-3], P < 0.05). However, there were no differences in the times required to resume their activities of daily living. In conclusion, perioperative rofecoxib, 50 mg per os, significantly decreased postoperative pain and the need for analgesic rescue medication, leading to a faster and improved quality of recovery after outpatient hernia surgery. However, perioperative use of rofecoxib failed to improve recovery end points in the postdischarge period.
IMPLICATIONS: Rofecoxib (50 mg per os), given before and after surgery, was effective in improving postoperative pain management, as well as the speed and quality of recovery after outpatient inguinal herniorrhaphy. However, it failed to accelerate the postdischarge resumption of normal activities of daily living.
UNLABELLED: We designed this randomized, double-blinded, placebo-controlled study to compare the analgesic effect of the cyclooxygenase-2 inhibitors rofecoxib and celecoxib with acetaminophen when administered before outpatient otolaryngologic surgery in 240 healthy subjects. Patients were assigned to one of four study groups: Group 1, control (vitamin C 500 mg); Group 2, acetaminophen 2 g; Group 3, celecoxib 200 mg; or Group 4, rofecoxib 50 mg. The first oral dose of the study medication was administered 15-45 min before surgery, and a second dose of the same medication was given on the morning after surgery. Recovery times, side effects, pain scores, and the use of rescue analgesics were recorded. Follow-up evaluations were performed at 24 and 48 h after surgery to assess postdischarge pain, analgesic requirements, nausea, and patient satisfaction with their postoperative pain management and quality of recovery. The need for rescue analgesia and peak pain scores were used as the primary end points for estimating efficacy, and the costs to achieve complete satisfaction with analgesia were used for the cost-efficacy comparisons. Premedication with oral rofecoxib (50 mg) or celecoxib (200 mg) was more effective than placebo in reducing postoperative pain scores and analgesic requirements in the postoperative care unit and after discharge. The analgesic efficacy of oral acetaminophen (2 g) was limited to the postdischarge period. Patient satisfaction with pain management was improved in all three treatment groups compared with placebo but was higher with celecoxib and rofecoxib compared with acetaminophen. Rofecoxib was also more effective than celecoxib in reducing pain and improving patient satisfaction after otolaryngologic surgery. Rofecoxib achieved complete satisfaction with pain control in one additional patient, who would not have otherwise been satisfied, at lower incremental costs to the institution compared with celecoxib. We conclude that rofecoxib 50 mg orally is more cost-effective for reducing postoperative pain and improving patient satisfaction with their postoperative pain management than celecoxib (200 mg) or acetaminophen (2 g) in the ambulatory setting.
IMPLICATIONS: Oral premedication with rofecoxib (50 mg) was more effective than celecoxib (200 mg) and acetaminophen (2 g) in reducing postoperative pain and in improving the quality of recovery and patient satisfaction with pain management after outpatient otolaryngologic surgery with only a small increase in cost of care.
UNLABELLED: Non-opioid analgesics are often used to supplement opioids for the management of perioperative pain. In this randomized, double-blinded, placebo-controlled study, we examined the effects of acetaminophen and a cyclooxygenase type-2 inhibitor, celecoxib, when administered alone or in combination, before elective otolaryngologic surgery in 112 healthy outpatients. Subjects were assigned to 1 of 4 study groups: Group 1, placebo (vitamin C, 500 mg per os [PO]); Group 2, acetaminophen 2000 mg PO; Group 3, celecoxib 200 mg PO; or Group 4, acetaminophen 2000 mg and celecoxib 200 mg PO. All patients received a standardized anesthetic technique. During the postoperative period, pain was assessed using a 10-point verbal rating scale. Recovery times, the need for rescue analgesics, side effects, and patient satisfaction scores were also recorded. The combination of acetaminophen and celecoxib was significantly more effective than placebo in reducing postoperative pain. Celecoxib, when administered alone or in combination with acetaminophen, improved patients' satisfaction with their postoperative analgesia. With the combination of acetaminophen and celecoxib, an additional expenditure of $6.16 would be required to obtain complete satisfaction with postoperative pain management in one additional patient who would not have been completely satisfied if he/she had received the placebo. However, oral celecoxib or acetaminophen alone was not significantly more effective than placebo in reducing postoperative pain when administered before surgery. We conclude that oral premedication with a combination of acetaminophen (2000 mg) and celecoxib (200 mg) was highly effective in decreasing pain and improving patient satisfaction after outpatient surgery.
IMPLICATIONS: Oral premedication with a combination of acetaminophen (2000 mg) and celecoxib (200 mg) was effective in decreasing pain and improving patient satisfaction after otolaryngologic surgery. However, acetaminophen (2000 mg) or celecoxib (200 mg) alone was not significantly more effective than placebo in reducing postoperative pain.
Reflex sympathetic dystrophy is a major complication following surgical treatment of fractures of the distal radius. Its pathogenesis is related to lipid peroxidation which damages vascular endothelial cells, increasing capillary permeability. Vitamin C is a natural antioxidant. The authors have made a comparative study of two groups of patients with isolated closed displaced fractures of the distal radius, which were reduced and stabilized by intrafocal pinning. Group 1 included 100 patients who were treated from 1995 until 1998 and who did not receive any vitamin C supplementation; group 2 included 95 patients who were treated from 1999 to 2002 and who received daily administration of one gram vitamin C orally during 45 days, starting on the day of fracture. The incidence of reflex sympathetic dystrophy was five time times lower in group 2 (2.1% versus 10%). This is in line with previous observations and lends credit to the value of vitamin C administration as a prophylactic measure to prevent the occurrence of reflex sympathetic dystrophy in patients who undergo surgical treatment of a displaced fracture of the distal radius.
Material & Methods: A parallel design, prospective randomized double masked placebo controlled clinical trial in which hundred patients more than 18 years of age with stable myopia of more than 1.5 diopters were enrolled. Preoperative visual acuity, corneal thickness and detailed slit lamp biomicroscopic examination were done. Patients were instructed to instill one drop of allotted drug (either ascorbic acid or placebo) four times daily along with the routine post LASIK medications for the three consecutive post-operative days. Visual acuity, corneal thickness, slit lamp biomicroscopy for corneal wound and interface, tolerance to drug and relief of pain was assessed on day one and day seven. Results were evaluated by preset questionnaires and comprehensive clinical examination on the day one and day seven. There were no significant differences on day one and day seven in visual acuity, corneal clarity, corneal thickness and corneal wound healing (p>0.05). Ascorbic acid for the first three days postoperatively after LASIK did not show any immediate clinical benefit over placebo.
