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Acupuncture Versus Titrated Morphine in Patients With Renal Colic (AcuRC)

Primary Purpose

Renal Colic

Status
Completed
Phase
Phase 3
Locations
Tunisia
Study Type
Interventional
Intervention
Traditional Acupuncture Session
Morphine Titration
Sponsored by
University of Monastir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Colic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age > 18 years old
  • Presenting with acute non complicated renal colic
  • Baseline VAS score >/= 70

Exclusion Criteria:

  • complicated renal colic
  • VAS score < 70
  • Pain of traumatic origin
  • Coagulation abnormalities
  • Skin affections impairing the use of pre-specified insertion points
  • Enable to use the VAS
  • Patients who received analgesics less than 6 hours prior to enrollment
  • Patients refusing or enable to give written informed consent
  • Pregnant women

Sites / Locations

  • Fattouma Bourguiba University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acupuncture

Titrated Morphine

Arm Description

Traditional Acupuncture Session:Patients in this group will benefit from a 30 minutes acupuncture session made by an experimented physician.

Morphine Titration:Patients will receive an intravenous titration of morphine by a qualified nurse.

Outcomes

Primary Outcome Measures

Pain score Change
Pain score is measured by a 100 millimeter visual analogue scale (VAS) and corresponds to the severity of the pain felt by the patient and varying from 0 (corresponding to no pain) to 100 (corresponding to the maximum imaginable pain).

Secondary Outcome Measures

Number of participants with treatment-related adverse events
Corresponds to the occurence of side effects related to the intervention. Side effects occurence is evaluated via a checklist for each study group and the degree of amputability is evaluated via a 3 point likert scale (1: not probable, 2: probable and 3 : very probable / almost certain). In the morphine group we followed patients for the occurence of drowsiness, dizziness, nausea and vomiting, respiratory distress and hypotension. In the acupuncture group we followed patients for the occurence of local rush / bleeding / itching, needle blockage and fainting

Full Information

First Posted
May 16, 2016
Last Updated
June 18, 2016
Sponsor
University of Monastir
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1. Study Identification

Unique Protocol Identification Number
NCT02781415
Brief Title
Acupuncture Versus Titrated Morphine in Patients With Renal Colic
Acronym
AcuRC
Official Title
Comparison of Acupuncture and Titrated (TM) Morphine in Patients Presenting to the Emergency Room (ER) With Acute Renal Colic (RC)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Monastir

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to compare the clinical efficacy and safety profiles of a 30 minutes acupuncture session performed at an ER of a tertiary hospital versus titrated intravenous morphine in the management of acute severe pain syndromes (defined as a visual analogue scale (VAS) score >/= 70) taking for example acute renal colic.
Detailed Description
acupuncture session performed at an ER of a tertiary hospital versus titrated intravenous morphine in the management of acute severe pain syndromes (defined as a visual analogue scale (VAS) score >/= 70) taking for example acute renal colic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Colic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
Traditional Acupuncture Session:Patients in this group will benefit from a 30 minutes acupuncture session made by an experimented physician.
Arm Title
Titrated Morphine
Arm Type
Active Comparator
Arm Description
Morphine Titration:Patients will receive an intravenous titration of morphine by a qualified nurse.
Intervention Type
Procedure
Intervention Name(s)
Traditional Acupuncture Session
Intervention Description
Skin disinfection was made by an antiseptic solution in the sites of insertion and sterile acupuncture needles were used (0.25 x 0.5 mm). Patients were installed in a seated position and needles were inserted perpendicularly through the skin to a depth of 1 - 2 cm until the "De Qi" was achieved. The "DeQi" corresponds to a feeling of numbness and tingling within the range of acupoint, The insertion sites are represented by the urinary bladder meridian points to the side of the pain (UB21, UB22, UB23, UB24, UB26, UB45, UB46, UB47, UB48 and UB49).
Intervention Type
Drug
Intervention Name(s)
Morphine Titration
Intervention Description
Morphine was previously prepared by a study nurse by diluting a 10 mg / 1 ml flakon of morphine chlorhydrate in a 9 ml solution of serum saline to obtain a 10 ml preparation (1 ml = 1 mg). An initial bolus of 0.1 mg per Kg of actual body weight of morphine chlorhydrate solution is administered. A titration dose of 0.1 mg / Kg of body weight was repeated every 5 minutes' interval until reaching the therapeutic goal.
Primary Outcome Measure Information:
Title
Pain score Change
Description
Pain score is measured by a 100 millimeter visual analogue scale (VAS) and corresponds to the severity of the pain felt by the patient and varying from 0 (corresponding to no pain) to 100 (corresponding to the maximum imaginable pain).
Time Frame
at baseline and 10, 20, 30, 45 and 60 minutes after the start of intervention
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events
Description
Corresponds to the occurence of side effects related to the intervention. Side effects occurence is evaluated via a checklist for each study group and the degree of amputability is evaluated via a 3 point likert scale (1: not probable, 2: probable and 3 : very probable / almost certain). In the morphine group we followed patients for the occurence of drowsiness, dizziness, nausea and vomiting, respiratory distress and hypotension. In the acupuncture group we followed patients for the occurence of local rush / bleeding / itching, needle blockage and fainting
Time Frame
during the 1 hour protocol and up to 2 hours after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age > 18 years old Presenting with acute non complicated renal colic Baseline VAS score >/= 70 Exclusion Criteria: complicated renal colic VAS score < 70 Pain of traumatic origin Coagulation abnormalities Skin affections impairing the use of pre-specified insertion points Enable to use the VAS Patients who received analgesics less than 6 hours prior to enrollment Patients refusing or enable to give written informed consent Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nouira Semir, Professor
Organizational Affiliation
University Hospital of Monastir
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fattouma Bourguiba University Hospital
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Acupuncture Versus Titrated Morphine in Patients With Renal Colic

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