Osteopathic Manipulative Treatment for Post-Operative Nausea and Vomiting
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      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.
    

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.
    

Intervention name(s): Osteopathic Manipulative Treatment
Intervention type(s): Procedure
Intervention description(s): 20 minute post-operative osteopathic manipulation as described in the protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Post-Operative Nausea; Nausea; Anesthesia; Osteopathic Manipulative Treatment; Osteopathic Manipulative Medicine; Manipulation, Osteopathic; Osteopathy; Texas College of Osteopathic Medicine