The Efficacy of P6 Acupressure in Reducing Postoperative Nausea and Vomiting in Patients Undergoing Craniotomy

NCT01617837 | Completed Phase 2

• 1 other identifier: 2011-281-31M
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate if P6 acupressure may reduce postoperative nausea and vomiting in neurosurgical patients undergoing craniotomy.

Conditions

Postoperative Nausea and Vomiting; Acupressure; Craniotomy

Keywords

Postoperative nausea and vomiting; P6 acupressure; Craniotomy.

Outcome Measures

Primary Outcomes (1)

• Postoperative nausea and vomiting

  During 48 hours postoperatively the patients are evaluating their nausea, registered on the same formula as the frequencies of vomiting. The first evaluation will take part when arriving to the postoperative care unit and then every hour for the first six hours, every third hour until hour 24 and thereafter every sixth hour from hour 24-48. A Numerical Rating Scale (NRS) from 0-10 will be used, where 0 means no nausea at all and 10 the worst nausea possible. The patients will be asked about whether they have experienced any nausea within the previous period of time.

  Postperative nauea and vomiting are registred regularly 0-48 hours postperatively.

Study Arms (2)

P6 acupressure group

ACTIVE COMPARATOR

In the end of the operation Sea-Band®, a single-sized elastic acupressure band with a plastic button, was placed unilaterally at the place of P6 (the P6 "Neiguan" acupoint, located about 3 cm proximal to the distal wrist, between the tendons of the flexor carpi radialis and the palmaris longus)to apply acupressure.

Device: P6 acupressure band

Placebo group

PLACEBO COMPARATOR

In the end of the operation an identical Sea-Band® with no button and thereby no acupressure was placed unilaterally at the place of P6.

Other: Placebo band

Interventions

P6 acupressure band DEVICE

Comparison between groups 0-48 hours postoperatively.

Also known as: Sea-Band®

P6 acupressure group

Placebo band OTHER

Comparison between groups 0-48 hours postoperatively

Also known as: Sea-Band® with no acupressure

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective infra-or supratentorial craniotomy
• Age ≥ 18 years

You may not qualify if:

• Patients not able to actively participate in the study according to mental status or communicating problems and patients receiving an antiemetic less than twelve hours before surgery

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

The Department of Neurosurgery, Umeå University Hospital

Umeå, Västerbotten County, 90185, Sweden

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• Ulrica Nilsson, PhD

  Umeå University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Associate Professor

Study Record Dates

• First Submitted: June 9, 2012
• First Posted: June 12, 2012
• Study Start: November 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 18, 2013

Record last verified: 2013-09

Locations

SE (1)