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Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Primary Purpose

Cholecystitis, Acute, Cholelithiasis, Nausea, Postoperative

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholecystitis, Acute

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient ages 18-64 American Society of Anesthesiology Physical Status I, II or III Patients scheduled to undergo laparoscopic cholecystectomy at Harris Health System Ben Taub Hospital Exclusion Criteria: Scheduled open cholecystectomy - excluded due to increased levels of pain in open procedures Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and perioperative medications Allergy to any of the standard anesthetic agents Patient inability to properly communicate with investigators (language barrier, dementia, delirium, psychiatric disorder) Patient or surgeon refusal

Sites / Locations

  • Ben Taub HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acupuncture

Control

Arm Description

Group Acupuncture: Points PC 6 bilaterally, LI 4 bilaterally, and Yin Tang will be needled using Seirin L Type 0.25 X 40 mm needles. MH 6 is located 2 cun (a traditional Chinese unit of length) above the wrist crease in between the tendons of palmaris longus and flexor carpi radialis. LI 4 is in the middle of first and second metacarpal bones. Yin Tang is located between the eyebrows. All needles will be removed once skin closure begins, and before emergence and extubation.

No acupuncture treatment provided

Outcomes

Primary Outcome Measures

Incidence of postoperative nausea and vomiting
Incidence of nausea and vomiting after surgery

Secondary Outcome Measures

Postoperative pain
Pain on scale 1-10 measured on arrival to PACU, discharge from PACU and at 24 hours post surgery
Total opioids used
Total opioid given, converted to oral morphine equivalents

Full Information

First Posted
July 26, 2023
Last Updated
October 9, 2023
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05975385
Brief Title
Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
Official Title
Acupuncture For Prevention Of Postoperative Nausea And Vomiting In Patients Undergoing Laparoscopic Cholecystectomy - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 9, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose is to find out if intraoperative acupuncture performed by needling PC 6 and LI4 point bilaterally, and Yin Tang point will help reduce the incidence postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy when added to a prophylactic regimen consisting of ondansetron and dexamethasone. The hypothesis is that the addition of this acupuncture treatment to ondansetron and dexamethasone given for prophylaxis will help reduce the incidence of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy when compared to patients receiving ondansetron and dexamethasone without acupuncture.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis, Acute, Cholelithiasis, Nausea, Postoperative, Vomiting, Postoperative, Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial. Group 1 - Acupuncture Group 2 - No acupuncture
Masking
ParticipantOutcomes Assessor
Masking Description
Patient will be under general anesthesia when treatment provided. They will not know whether or not they received acupuncture treatment. Postoperative assessors will not know which group the patient is in.
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
Group Acupuncture: Points PC 6 bilaterally, LI 4 bilaterally, and Yin Tang will be needled using Seirin L Type 0.25 X 40 mm needles. MH 6 is located 2 cun (a traditional Chinese unit of length) above the wrist crease in between the tendons of palmaris longus and flexor carpi radialis. LI 4 is in the middle of first and second metacarpal bones. Yin Tang is located between the eyebrows. All needles will be removed once skin closure begins, and before emergence and extubation.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No acupuncture treatment provided
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture at points points PC 6 bilaterally, LI 4 bilaterally, and Yin Tang
Primary Outcome Measure Information:
Title
Incidence of postoperative nausea and vomiting
Description
Incidence of nausea and vomiting after surgery
Time Frame
Postoperative: 0-1 hours, 1-6 hours, 6-12 hours, 12-24 hours
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
Pain on scale 1-10 measured on arrival to PACU, discharge from PACU and at 24 hours post surgery
Time Frame
24 hours
Title
Total opioids used
Description
Total opioid given, converted to oral morphine equivalents
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient ages 18-64 American Society of Anesthesiology Physical Status I, II or III Patients scheduled to undergo laparoscopic cholecystectomy at Harris Health System Ben Taub Hospital Exclusion Criteria: Scheduled open cholecystectomy - excluded due to increased levels of pain in open procedures Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and perioperative medications Allergy to any of the standard anesthetic agents Patient inability to properly communicate with investigators (language barrier, dementia, delirium, psychiatric disorder) Patient or surgeon refusal
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaime Ortiz, MD, MBA
Phone
713-873-2860
Email
jaimeo@bcm.edu
Facility Information:
Facility Name
Ben Taub Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaime Ortiz, MD,MBA
First Name & Middle Initial & Last Name & Degree
Jaime Ortiz

12. IPD Sharing Statement

Plan to Share IPD
No

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Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

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