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Osteopathic Manipulative Treatment for Post-Operative Nausea and Vomiting

This study has been completed.
Sponsor:
Information provided by:
University of North Texas Health Science Center
ClinicalTrials.gov Identifier:
NCT00387361
First received: October 12, 2006
Last updated: January 11, 2011
Last verified: January 2011
  Purpose

The purpose of this study is to determine if Osteopathic Manipulative Treatment (OMT) is effective in reducing nausea and vomiting experienced by patients recovering from anesthesia. OMT is a treatment in which the physician places his hands on areas of the body and applies pressure to correct disturbances in one area that may be related to a problem in another area of the body. Osteopathic Manipulative Medicine is a specialty for a physician who uses OMT.

The hypothesis of this study is when OMT is combined with standard-of-care prophylactic anti-emetic therapy in patients following administration of inhalational anesthesia, in comparison to a control group receiving only standard-of-care anti-emetic prophylaxis there will be a reduction in the incidence and severity of PONV.


Condition Intervention Phase
Postoperative Nausea and Vomiting
Procedure: Osteopathic Manipulative Treatment
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Osteopathic Manipulative Treatment (OMT) as Possible Prophylaxis Against Post-Operative Nausea and Vomiting (PONV) in Patients Receiving Inhalational Anesthesia

Resource links provided by NLM:


Further study details as provided by University of North Texas Health Science Center:

Primary Outcome Measures:
  • Reduction in the episodes of emesis
  • Reduction in the intensity of nausea

Secondary Outcome Measures:
  • Post-anesthesia recollection of treatment

Enrollment: 20
Study Start Date: December 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Procedure: Osteopathic Manipulative Treatment
20 minute post-operative osteopathic manipulation as described in the protocol
No Intervention: 2

Detailed Description:

This research study is a prospective, randomized, single-blinded, controlled, clinical trial under the principal investigator, Hollis King, DO, PhD with the University of North Texas - Health Science Center, Texas College of Osteopathic Medicine. The purpose of this study is to determine the effectiveness of osteopathic manipulative treatment (OMT) as an adjunctive modality to standard medical care for reduction of post-operative nausea and vomiting (PONV). This is the first attempt to study the treatment of PONV utilizing OMM; this study is being conducted as a pilot study

The hypothesis of this study is when OMT is combined with standard-of-care prophylactic anti-emetic therapy in patients following administration of inhalational anesthesia, in comparison to a control group receiving only standard-of-care anti-emetic prophylaxis there will be a reduction in the incidence and severity of PONV.

Two aims will guide this study toward evaluation of the hypothesis:

AIM I: To demonstrate the effect of OMT and standard care on the number of episodes of emesis experienced post-operatively by subjects having undergone anesthesia utilizing inhalational anesthesia (alone or in combination with intravenous anesthetics). All subjects will receive the treatment or "no-treat" protocol to which they are randomized. Data will be collected prior to discharge from the post-anesthesia care unit (PACU) to enumerate the episodes of emesis experienced by each study subject. Subjects will be asked to complete the Ambulatory Surgery-Rhodes Index of Nausea, Vomiting, and Retching (AS-RINVR) 24-48 hours following surgery when a post-study questionnaire is completed.1

AIM II: To demonstrate the effect of OMT and standard care on the intensity of nausea experienced post-operatively by subjects having undergone anesthesia utilizing inhalational anesthesia (alone or in combination with intravenous anesthetics). Following a subject's completion of the treatment protocol (or "no-treat" if so randomized), the nausea visual analog scale (VAS) validated by Boogaerts will be employed at 30 minutes, 1 hour, and 24-36 hours following their post-operative, post-anesthesia treatment protocol. Results will be compared between the control and experimental group for differences.

Osteopathic manipulative medicine (OMM) and OMT seek, in general, to facilitate a more optimal and often faster return to health and homeostasis. Though individuals largely seek out OMT for alleviation of structural and musculoskeletal complaints, its uses have been speculated and discovered to have effects also on physiologic mechanisms. Osteopathic manipulative treatment maneuvers to the head, neck, and upper thoracic spine may impart postulated mechanisms for PONV.3 Successful treatment will be measured by the reduction of PONV, as evaluated on several outcome measures, in a group of subjects receiving post-operative OMT along with standard-of-care treatment over those in the control group only receiving standard-of-care treatment for their PONV. Successful completion of all of the above specific aims will not only validate the hypothesis of this study but will also establish the study's effect and feasibility for future study. Additionally, this pilot study will establish the statistical trends needed to establish effect size data which is needed for power analysis and sample size estimates for future studies.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Surgery Type: orthopedic surgical procedures of the extremities (including, but not limited to, shoulder, elbow, wrist, hip, knee, and ankle) with estimated blood loss < 250 cc
  • Surgery Duration: 30-180 minutes
  • Anesthesia Type: General
  • Procedure to be conducted at John Peter Smith Hospital
  • Age: 18-75
  • American Society of Anesthesiologists Classification < 3

Exclusion Criteria:

  • Presence or likelihood of joint sepsis
  • Confirmed or suspected pregnancy
  • *Increased intracranial pressure, skull fracture, or head trauma within 3 months prior to surgery (by history)
  • *Oxygen dependence at home (by history)
  • *Active or chronic hepatitis B or C (by history)
  • *Hepatocellular carcinoma (by history)
  • *Disruption of Blood-Brain barrier: uncontrolled HTN, tumor (current or history of), meningitis or encephalitis (within 3 months prior to surgery), epilepsy (by history)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00387361

Sponsors and Collaborators
University of North Texas Health Science Center
Investigators
Principal Investigator: Hollis H King, DO, PhD UNTHSC - TCOM, Department of OMM; Osteopathic Research Center
Study Director: Simon L Schrick-Senasac, OMS-IV, PDF UNTHSC-TCOM, Department of OMM
  More Information

Additional Information:
Publications:
Responsible Party: Hollis H King, DO, PhD, Adjunct Faculty
ClinicalTrials.gov Identifier: NCT00387361     History of Changes
Other Study ID Numbers: 2006-56
Study First Received: October 12, 2006
Last Updated: January 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Texas Health Science Center:
Post-Operative Nausea
Nausea
Anesthesia
Osteopathic Manipulative Treatment
Osteopathic Manipulative Medicine
Manipulation, Osteopathic
Osteopathy
Texas College of Osteopathic Medicine

Additional relevant MeSH terms:
Nausea
Postoperative Nausea and Vomiting
Vomiting
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 25, 2014