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.
Complex regional pain syndrome (CRPS) type I may occur as complication after any type of surgery for basal joint arthritis of the thumb. We investigated prospectively in an ongoing study our results after a fully standardized treatment with a total joint prosthesis under vitamin C prophylaxis.Patients with trapeziometacarpal arthritis stage II or III according to Dell, and no benefit from conservative treatment, were selected to undergo joint replacement with a semi-constrained hydroxyapatite coated prosthesis.First web opening and visual analogue scale (VAS) scores for pain, activities of daily living (ADL) and satisfaction were taken pre and postoperatively. Vitamin C 500 mg daily was started two days prior to surgery during 50 days as prevention for CRPS. Post-operative treatment was functional.We performed 40 implantations for trapeziometacarpal arthritis in 34 patients (mean age 60.8 years; 27 females, 7 males) with a mean follow-up of 44 months. Operations were performed in day care under regional (or general) anesthesia.First web opening increased with 15.4 degrees and there was a significant improvement for pain, ADL and satisfaction as well (p = 0.000). Patient satisfaction was strongly associated with the amount of pain reduction. According to the Veldman and IASP criteria, there were no cases of CRPS.The overall complication rate for this procedure is high. Literature reports 5 cases of CRPS after 38 operations with the same implant (13%). We advise vitamin C as prophylaxis against CRPS in trapeziometacarpal joint replacement.
Operative and conservative treatment of wrist fractures might lead to complex regional pain syndrome (CRPS) type I. In our multicenter dose response study in which patients with distal radial fractures were randomly allocated to placebo or vitamin C in a daily dose of 200mg, 500mg or 1500mg during 50 days, an operated subgroup was analyzed. 48 (of 427) fractures) were operated (11.2%). Twenty-nine patients (60%) were treated with external fixation, 14 patients (29%) with K-wiring according to Kapandji and five patients (10%) with internal plate fixation. The 379 remaining patients were treated with a plaster. In the operated group of patients who received vitamin C no CRPS (0/37) was seen in comparison with one case of CRPS (Kapandji technique) in the operated group who received placebo (1/11 = 9%, p=.23). There was no CRPS after external fixation. In the conservatively treated group 17 cases of CRPS (17/379 = 4.5%) occurred in comparison with one in case of CRPS in the operated group (1/48 = 2.1%, p=.71). External fixation doesn’t necessarily lead to a higher incidence of CRPS in distal radial fractures. Vitamin C may also play a role in this. This subgroup analysis in operated distal radial fractures showed no CRPS occurrence with vitamin C prophylaxis.
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.
Patients with trapeziometacarpal joint arthritis stage II or III (according to Dell) and no benefit from non-operative therapy were selected to undergo joint arthroplasty. We performed 32 arthroplasties for first carpometacarpal arthritis in 27 patients using a cementless total trapeziometacarpal joint prosthesis. We undertook a prospective cohort study and evaluated the clinical results of total joint arthroplasty after an average of 39 months. Visual analogue scale (VAS) scores for pain, daily activities (ADL) and satisfaction were taken pre- and postoperatively, and the first web opening was measured. First web opening improved significantly as did pain, ADL and patient satisfaction. Surgery of arthritis of the first carpometacarpal joint can be complicated by complex regional pain syndrome (CRPS) type I. In all our patients Vitamin C 500 mg daily was started two days before surgery and continued during 50 days. There were no cases of CRPS under vitamin C prophylaxis. These results justify further investigation in a randomised clinical trial.
BACKGROUND: Complex regional pain syndrome type I is treated symptomatically. A protective effect of vitamin C (ascorbic acid) has been reported previously. A dose-response study was designed to evaluate its effect in patients with wrist fractures.
METHODS: In a double-blind, prospective, multicenter trial, 416 patients with 427 wrist fractures were randomly allocated to treatment with placebo or treatment with 200, 500, or 1500 mg of vitamin C daily for fifty days. The effect of gender, age, fracture type, and cast-related complaints on the occurrence of complex regional pain syndrome was analyzed.
RESULTS: Three hundred and seventeen patients with 328 fractures were randomized to receive vitamin C, and ninety-nine patients with ninety-nine fractures were randomized to receive a placebo. The prevalence of complex regional pain syndrome was 2.4% (eight of 328) in the vitamin C group and 10.1% (ten of ninety-nine) in the placebo group (p=0.002); all of the affected patients were elderly women. Analysis of the different doses of vitamin C showed that the prevalence of complex regional pain syndrome was 4.2% (four of ninety-six) in the 200-mg group (relative risk, 0.41; 95% confidence interval, 0.13 to 1.27), 1.8% (two of 114) in the 500-mg group (relative risk, 0.17; 95% confidence interval, 0.04 to 0.77), and 1.7% (two of 118) in the 1500-mg group (relative risk, 0.17; 95% confidence interval, 0.04 to 0.75). Early cast-related complaints predicted the development of complex regional pain syndrome (relative risk, 5.35; 95% confidence interval, 2.13 to 13.42).
CONCLUSIONS: Vitamin C reduces the prevalence of complex regional pain syndrome after wrist fractures. A daily dose of 500 mg for fifty days is recommended.
We conducted a randomised double-blind placebo-controlled single-centre study to compare the effect of preoperative ibuprofen 600 mg, diclofenac 100 mg, paracetamol 1 g with codeine 60 mg or placebo (Vitamin C 50 mg) tablets for relief of postoperative pain in 119 patients who had day case operations under general anaesthesia for removal of impacted third molars. Patients were given the tablets 1 h before operation. Pain was assessed using visual analogue scales and verbal rating scales preoperatively at 15 and 30 min and 1 and 3 h postoperatively. After they had gone home, patients were contacted by telephone at 6 and 24 h postoperatively to find out whether they had any adverse effects from the analgesics. There was no significant difference in the extent of postoperative pain among the four groups, but the placebo group had significantly shorter times before their first request for postoperative analgesics (median 17 min, range 14-90) than the diclofenac group (median 32, range 15-150).Preoperative analgesics at the stated doses are effective in providing immediate postoperative pain control after operations on third molars. There were, however, some side-effects including nausea, vomiting, headaches, and gastrointestinal discomfort, but there were no significant differences among the active analgesic groups with respect to adverse events either shortly after operation or at 6 or 24 h.
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.
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.
