Bryson 2010.
Methods | Randomized, placebo‐controlled trial. Participants, personnel, and outcome assessors were blinded. The purpose of this trial was to determine if intravenous lidocaine limited to the intraoperative period reduces length of hospital stay and improves functional recovery following abdominal hysterectomy. The study was conducted in Canada from June 2007 to October 2008 (NCT00382499). |
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Participants | Number assessed for eligibility: 279 Number randomized: 93→ 46:47 Number analysed: 44:46 Inclusion criteria Women, abdominal hysterectomy, ASA I to II Exclusion criteria ASA III, IV, and V, BMI < 18.5 or > 30 kg*m‐2, unable to use PCA, liver dysfunction, creatinine clearance < 50 ml*mins‐1, seizure disorder, hypersensitivity/allergy to amide‐type local anaesthetics study medication, chronic pain, opioid use more than once per week. Baseline details Experimental group (n = 44) Mean age (years): 46.3 M = 0%, F = 100% Mean weight (kg): 70.4 ASA I/II: 13:31 Mean duration of anaesthesia (mins): 105 Main surgical procedures: abdominal hysterectomy Control group (n = 46) Mean age (years): 45.4 M = 0%, F = 100% Mean weight (kg): 69.7 ASA I/II: 18:28 Mean duration of anaesthesia (mins): 108 Main surgical procedures: abdominal hysterectomy |
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Interventions |
Experimental group (46 patients) Lidocaine subjects received prior to induction of anaesthesia an intravenous bolus of 1.5 mg/kg followed by an infusion of 3 mg/kg/hr until skin closure. Control group (47 patients) Control subjects received matching placebo. |
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Outcomes | The primary endpoint of the study was length of hospital stay. Dichotomous
Continuous
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Notes |
Medication "All patients received antiemetic prophylaxis with dexamethasone 8 mg and ondansetron 4 mg. All wounds were infiltrated with 20 ml of 0.25% bupivacaine with adrenaline at skin closure. Postoperatively, all patients received celecoxib 200 mg po q12hr and acetaminophen 650 mg po q4hr until hospital discharge. Intravenous patient‐controlled morphine was prescribed with the following settings: boluses of 0.02 mg/kg, no continuous infusion, and a one‐hour maximum of 0.16 mg/kg/hr. Intravenous analgesia was discontinued when the patient tolerated a clear fluid diet. Morphine 5‐10 mg po q4hr prn was ordered for pain that was not controlled with celecoxib and acetaminophen." Anaesthesia All patients received a standardized balanced general anaesthetic. Funding "Trial expenses were funded by the Chair’s Research Fund, Department of Anesthesiology, University of Ottawa. Dr. Bryson was supported by the Ottawa Hospital Anesthesia Alternate Funds Association." |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers table. |
Allocation concealment (selection bias) | Low risk | Central allocation. Quote: "campus‐specific randomization schedules were held by the research pharmacist at each campus. Study medications …prepared by the pharmacist in identical syringes labelled only with the patient’s unique study number". |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "research personnel, patients, and attending anaesthesiologists were blinded to the contents of the syringes". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "outcome measures were recorded by study personnel blinded to treatment allocation". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropout rate (experimental/control): 4%:2%. Quote: "five patients could not be contacted for follow‐up 7 days after surgery." |
Selective reporting (reporting bias) | Low risk | The study protocol is available and all of the study's prespecified primary outcomes that are of interest in the review have been reported. NCT00382499 |
Other bias | Low risk | The study appears to be free of other sources of bias. |