NCT00387361

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

January 12, 2011

Status Verified

January 1, 2011

Enrollment Period

1.2 years

First QC Date

October 12, 2006

Last Update Submit

January 11, 2011

Conditions

Postoperative Nausea and Vomiting

Keywords

Post-Operative NauseaNauseaAnesthesiaOsteopathic Manipulative TreatmentOsteopathic Manipulative MedicineManipulation, OsteopathicOsteopathyTexas College of Osteopathic Medicine

Outcome Measures

Primary Outcomes (2)

  • Reduction in the episodes of emesis

  • Reduction in the intensity of nausea

Secondary Outcomes (1)

  • Post-anesthesia recollection of treatment

Study Arms (2)

1

EXPERIMENTAL
Procedure: Osteopathic Manipulative Treatment

2

NO INTERVENTION

Interventions

Osteopathic Manipulative TreatmentPROCEDURE

20 minute post-operative osteopathic manipulation as described in the protocol

1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Fetzer SJ, Hand MC, Bouchard PA, Smith H, Jenkins MB. Evaluation of the Rhodes Index of Nausea and Vomiting for ambulatory surgery patients. J Adv Nurs. 2004 Jul;47(1):74-80. doi: 10.1111/j.1365-2648.2004.03067.x.

    PMID: 15186470BACKGROUND

  • Scuderi PE, Conlay LA. Postoperative nausea and vomiting and outcome. Int Anesthesiol Clin. 2003 Fall;41(4):165-74. doi: 10.1097/00004311-200341040-00012. No abstract available.

    PMID: 14574220BACKGROUND

  • Boogaerts JG, Vanacker E, Seidel L, Albert A, Bardiau FM. Assessment of postoperative nausea using a visual analogue scale. Acta Anaesthesiol Scand. 2000 Apr;44(4):470-4. doi: 10.1034/j.1399-6576.2000.440420.x.

    PMID: 10757584BACKGROUND

  • Willard FH. Autonomic nervous system. In: Ward, Robert C., D.O., F.A.A.O., ed. Foundations for Osteopathic Medicine. 2nd ed. Philadelphia: Lippincott Williams & Wilkins; 2003:90.

    BACKGROUND

  • American Society of Anesthesiologists. ASA Physical Status Classification System. Available at: http://www.asahq.org/clinical/physicalstatus.htm. Accessed May 11, 2006.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Postoperative Nausea and VomitingNausea

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Hollis H King, DO, PhD

    UNTHSC - TCOM, Department of OMM; Osteopathic Research Center

    PRINCIPAL INVESTIGATOR

  • Simon L Schrick-Senasac, OMS-IV, PDF

    UNTHSC-TCOM, Department of OMM

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 12, 2006

First Posted

October 13, 2006

Study Start

December 1, 2006

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

January 12, 2011

Record last verified: 2011-01