Effects of Preoperative Carbohydrate Rich Drinks on Immediate Postoperative Outcome in Total Knee Arthroplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Henry Ford Health System
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Post operative nausea
Study Overview
Brief Summary
The aim of this study is to investigate the effect of preoperative carbohydrate rich drinks on postoperative nausea and vomiting in total knee arthroplasty. This is a prospective, double blinded, randomized controlled trial.
Detailed Description
Postoperative nausea and vomiting (PONV) continues to pose serious challenge to orthopaedic adult reconstructive surgeons, even after recent advances in anesthesia and improvements in perioperative care. Preoperative carbohydrate loading has been well studied in non-arthroplasty surgical fields. It has been shown to benefits which include decreased postoperative catabolism and insulin resistance, dampened metabolic stress response, thus decreased postoperative pain, anxiety, nausea, and vomiting. To the investigators knowledge, there is currently no literature describing the effects of preoperative carbohydrate rich drinks (CHO) in the setting of elective total joint arthroplasty. Using a prospective, randomized, double blind, placebo controlled model, the investigators aim to determine the effect of CHO on PONV in total knee arthroplasty.
The investigators plan to include a total of 150 patients in this study. All the arthroplasty surgeons at HF Main Campus expect to participate. Estimating approximately 20 patients enrolled per month, enrollment would likely occur over time span of 8 months.
Patients who are scheduled for elective, primary total knee arthroplasty will be recruited and consented in preoperative clinic visit according to the inclusion and exclusion criteria as outlined. Screening and consenting will be performed by the orthopaedic surgeon, resident, physician assistant, or nurse practitioner in clinic, who will be trained for this study. Patients who elect to participate will be randomized to CHO drink (Group A), placebo drink (Group B), or traditional fasting/no drink (Group C). Randomization will occur prior to enrollment in batches of twenty. Patients and treatment team will be blinded to the assignment. Enrolled subjects will be given a kit which will include study information, instructions for participation, data collection questionnaire (included with this submission), multiple-alarm timer, and two beverage bottles (labeled Drink 1 and Drink 2) for those in Group A or B. Group C will receive the kit, but without beverage. A research assistant who is not involved in any of the subjects' care will be responsible for preparation of the kits.
Beverage in Group A will consist of a clear, non-carbonated lemon-flavored, iso-osmolar carbohydrate drink (Nutricia preOp; 12.5% carbohydrates, 50kcal/100mL, 260mOsm/kg, pH 5.0). This drink has been previously used in studies supporting Enhanced Recovery After Surgery (ERAS) Society Consensus Guidelines. Beverage in Group B will consist of the same quantity of clear, lemon flavored water (Nestle Splash Lemon; 0kcal/100mL). All beverages will be bottled in clear PET plastic IPEC tamper evident bottles. Bottles will be labeled Drink 1 (800 mL) or Drink 2 (400 mL). Neither subjects nor treatment team will be able to identify type of beverage, however each drink label will include a special code, available only to research assistant to be able to identify contents of bottle (treatment vs placebo).
During the evening before surgery (8:00-10:00 PM), subjects in Group A and B will consume Drink 1 (800 mL) of their respective drink. After midnight, nothing will be allowed by mouth, except for except for single morning dose of appropriate drink (Drink 2, 400 mL) in Group A and Group B. Subjects will be instructed to consume morning drink 3 hours prior to scheduled time of surgery, and be completely consumed at least 2 hours prior to surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Research assistant who is not involved in any of the patients clinical care is responsible for randomization collection of data. All others are blinded to the groups involved.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adult patients (>18 years of age) scheduled for elective, unilateral, primary total knee arthroplasty
- •Able to give valid consent
Exclusion Criteria
- •Impaired gastrointestinal motility
- •On pro-motility medication
- •Pregnancy
- •HbA1c > 7.5
- •Fasting glucose >200
- •Acquired immunodeficiency
- •Renal failure (creatinine > 2 mg/dL)
- •Cirrhosis
- •Severe malnutrition.
Arms & Interventions
Carbohydrate Rich Drink
Group A will receive the carbohydrate rich drink, Nutricia preOp. This is the intervention group.
Intervention: Nutricia preOp (Dietary Supplement)
Placebo Drink
Group B will receive placebo, Nestle Splash Lemon Flavor Water (Placebo) (similarly flavored and appearing water, however with no calorie, carbohydrate or nutritional content).
Intervention: Nestle Splash Lemon Flavor Water (Placebo) (Other)
No Drink
Group C will not receive any drink. This group will follow normal protocol.
Outcomes
Primary Outcomes
Post operative nausea
Time Frame: 24 hours postoperatively
Nausea, assess by questionnaire, 10 point scale (0 = no nausea, 10 = very nauseous, and medical record.
Post operative vomiting
Time Frame: 24 hours postoperatively
Vomiting, assess by questionnaire, 10 point scale (0 = no vomiting, 10 = copious emesis, and medical record notes of emesis.
Post operative nausea
Time Frame: 4 hours postoperatively
Nausea, assess by questionnaire, 10 point scale (0 = no nausea, 10 = very nauseous, and medical record.
Post operative nausea
Time Frame: 12 hours postoperatively
Nausea, assess by questionnaire, 10 point scale (0 = no nausea, 10 = very nauseous, and medical record.
Post operative vomiting
Time Frame: 4 hours postoperatively
Vomiting, assess by questionnaire, 10 point scale (0 = no vomiting, 10 = copious emesis, and medical record notes of emesis.
Post operative vomiting
Time Frame: 12 hours postoperatively
Vomiting, assess by questionnaire, 10 point scale (0 = no vomiting, 10 = copious emesis, and medical record notes of emesis.
Secondary Outcomes
- Incidence of secondary adverse events(From the time of surgery until the time of hospital discharge, assessed up to 1 month postoperatively)
- Post operative opiate consumption(From the time of surgery until the time of hospital discharge, assessed up to 72 hours postoperatively)
- Peri operative hunger and discomfort(4 hours, 12 hours, and 24 hours postoperatively)
- Length of hospital stay(From the time of hospital admission following surgery, until the time of hospital discharge as recorded in EMR, assessed up to 1 month)
- Post operative pain scores(From the time of surgery until the time of hospital discharge, assessed up to 72 hours postoperatively)
Investigators
Michael Charters, MD
Principal Investigator, MD, Adult Joint Reconstruction
Henry Ford Health System
