Pain
Conditions
Keywords
Ketamine, Anesthesia, Pain, Outpatient surgery
Brief summary
Hypothesis: The intraoperative administration of ketamine will result in a 30% reduction in opiate requirement following endometrial ablation surgery and the intraoperative administration of ketamine will result in a decreased time to meet discharge criteria in the PACU following endometrial ablation surgery. The research question is Does intraoperative administration of ketamine result in decreased postoperative opiate requirement and time to discharge from the postanesthesia recovery unit (PACU) following hysteroscopic endometrial ablation.
Detailed description
Preoperatively: Subjects will be recruited up to 21days prior to the day of surgery. After informed consent is obtained, subjects will be randomly assigned to one of two groups: Group A: Saline group Group B: 1% Ketamine group A verbal rating scale (VRS) will be used to assess pain preoperatively. The patient will be asked to identify the severity of pain by indicating on a scale of 0-10 where 0 is no pain and 10 is the worst pain imaginable. Baseline Quality of Recovery will be obtained. (Appendix F) Subjects will be randomized prior to surgery to either Group A or Group B. The randomization table is computer generated. There is a 50% allocation to each group. Intraoperatively: Standard anesthetic monitoring will be used including monitoring of processed EEG including either the bi-spectral index (BIS) or similar standard of care ASA monitor. A standardized intraoperative anesthetic plan will be utilized by the anesthesia personnel. (Appendix A). Study drug will be prepared and labeled in 10mL syringes by research personnel who will not be involved in the study assessments. Study drug will be administered on initial insertion of Novasure® device (Appendix B). Postoperatively: Pain scores in the PACU will be assessed using the VRS upon admission and every 30 minutes thereafter until discharge criteria are met. Additionally, nausea, vomiting and retching episodes will be recorded using a VRS. Postoperative analgesic and antiemetic therapy will be standardized and total amounts of these agents will be recorded Assessment of psychomimetic effects including sedation and agitation will be assess postoperatively prior to discharge using the Richmond Agitation/Sedation Scale (Appendix D). Acute recovery will be assessed using the Modified Post Anesthesia Discharge Scoring System (MPADSS) (Appendix E). A score of 8 or greater will indicate discharge readiness. Time to fulfill discharge criteria will be recorded. Any other adverse events and medications required will be recorded. These data will be recorded by research personnel who will be blinded to the study group assignments. Subjects will be contacted by telephone 24 hours after surgery to assess post-discharge quality of recovery (Appendix F).
Interventions
DRUGGroup A: Saline Group
Saline continuous infusion
DRUGGroup B: 1% Ketamine group
Administration of 1% ketamine intravenously.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Gender: Female * Age: 18-65 years * Non-pregnant, non-lactating * Surgery: Outpatient hysteroscopic Novasure® endometrial ablation * Language: English speaking * Consent: Obtained
Exclusion criteria
* Patient refusal * Under 18 or over age 65 * Non-English Speaking * Pregnancy, Breast feeding * Hysteroscopic procedures using Thermachoice® ablation device * Chronic use or addiction to opiates, sedatives, non-opiate analgesics * History of heavy alcohol usage (\>4 drinks/day) * Significant cardiovascular or pulmonary disease * Psychiatric or emotional disorder * Allergy to anesthetic agents utilized in the protocol * Glaucoma * Thyrotoxicosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery Score Post Operative at 24 Hours | 24 hours post operative | Quality of recovery 40 score at 24 hours after the surgical procedure. 40 being a poor recovery and 200 being a good recovery. |
Countries
United States
Participant flow
Recruitment details
Date of recruitment 03/15/2010-02/14/2013.
Participants by arm
| Arm | Count |
|---|---|
| Group A: Saline Group Group A: Saline group , infusion of saline intravenously
Group A: Saline Group: Saline continuous infusion | 12 |
| Group B: 1% Ketamine Group Group B: Infusion of ketamine 1% intravenously
Group B: 1% Ketamine group: Administration of 1% ketamine intravenously. | 10 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Change in surgical procedure | 0 | 1 |
Baseline characteristics
| Characteristic | Group B: 1% Ketamine Group | Group A: Saline Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 12 Participants | 22 Participants |
| Age, Continuous | 43.12 years STANDARD_DEVIATION 6.19 | 45.08 years STANDARD_DEVIATION 3.88 | 44.28 years STANDARD_DEVIATION 4.43 |
| Region of Enrollment United States | 10 participants | 12 participants | 22 participants |
| Sex: Female, Male Female | 10 Participants | 12 Participants | 22 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 12 | 0 / 9 |
| serious Total, serious adverse events | 0 / 12 | 0 / 9 |
Outcome results
Primary
Quality of Recovery Score Post Operative at 24 Hours
Quality of recovery 40 score at 24 hours after the surgical procedure. 40 being a poor recovery and 200 being a good recovery.
Time frame: 24 hours post operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: Saline Group | Quality of Recovery Score Post Operative at 24 Hours | 191.2 units on scale | Standard Deviation 9.15 |
| Group B: 1% Ketamine Group | Quality of Recovery Score Post Operative at 24 Hours | 191.1 units on scale | Standard Deviation 11.3 |
p-value: 0.947Wilcoxon (Mann-Whitney)