Analgesic Effect of Ketamine in Patients Undergoing Hysteroscopic Endometrial Thermal Ablation Surgery
| Status: | Terminated |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | March 2010 |
| End Date: | March 2013 |
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".
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".
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).
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).
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
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