Analgesic Effect of Ketamine in Patients Undergoing Hysteroscopic Endometrial Thermal Ablation Surgery

Pain Clinical Trial

Official title:

Analgesic Effect of Ketamine in Patients Undergoing Hysteroscopic Endometrial Thermal Ablation Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01106846
• Other study ID #: STU00026695
• Status: Terminated
• Phase: N/A
• First received: April 16, 2010
• Last updated: July 20, 2015
• Start date: March 2010
• Est. completion date: March 2013

Study information

• Verified date: July 2015
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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".

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Group A: Saline Group
Saline continuous infusion
• Group B: 1% Ketamine group
Administration of 1% ketamine intravenously.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	Prentice Women's Hosptial	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (9)

Bowdle TA, Radant AD, Cowley DS, Kharasch ED, Strassman RJ, Roy-Byrne PP. Psychedelic effects of ketamine in healthy volunteers: relationship to steady-state plasma concentrations. Anesthesiology. 1998 Jan;88(1):82-8. — View Citation

De Iaco P, Marabini A, Stefanetti M, Del Vecchio C, Bovicelli L. Acceptability and pain of outpatient hysteroscopy. J Am Assoc Gynecol Laparosc. 2000 Feb;7(1):71-5. — View Citation

Deng XM, Xiao WJ, Luo MP, Tang GZ, Xu KL. The use of midazolam and small-dose ketamine for sedation and analgesia during local anesthesia. Anesth Analg. 2001 Nov;93(5):1174-7. — View Citation

Jansen FW, Vredevoogd CB, van Ulzen K, Hermans J, Trimbos JB, Trimbos-Kemper TC. Complications of hysteroscopy: a prospective, multicenter study. Obstet Gynecol. 2000 Aug;96(2):266-70. — View Citation

Lau WC, Ho RY, Tsang MK, Yuen PM. Patient's acceptance of outpatient hysteroscopy. Gynecol Obstet Invest. 1999;47(3):191-3. — View Citation

MacPherson RD, Woods D, Penfold J. Ketamine and midazolam delivered by patient-controlled analgesia in relieving pain associated with burns dressings. Clin J Pain. 2008 Sep;24(7):568-71. doi: 10.1097/AJP.0b013e31816cdb20. — View Citation

Schenker JG, Margalioth EJ. Intrauterine adhesions: an updated appraisal. Fertil Steril. 1982 May;37(5):593-610. Review. — View Citation

White PF, Way WL, Trevor AJ. Ketamine--its pharmacology and therapeutic uses. Anesthesiology. 1982 Feb;56(2):119-36. — View Citation

Wong AY, Wong K, Tang LC. Stepwise pain score analysis of the effect of local lignocaine on outpatient hysteroscopy: a randomized, double-blind, placebo-controlled trial. Fertil Steril. 2000 Jun;73(6):1234-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	24 hours post operative	No