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Effective Postoperative Pain Relief After Laparoscopic Cholecystectomy With TENS

Primary Purpose

Pain, Postoperative

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
TENS (transcutaneous electrical nerve stimulation)
iv opioid
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Pain, Transcutaneous Electric Nerve Stimulation, Analgesics, Opioid

Eligibility Criteria

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

Inclusion Criteria:

For randomized patients:

• Patients who reports postoperative pain intensity ≥ 3 according to numeric rating scale during the stay in the post-anesthesia care unit after laparoscopic cholecystectomy.

For controls:

• Patients who reports postoperative pain intensity <3 according to numeric rating scale during the stay in the post-anesthesia care unit after laparoscopic cholecystectomy

Exclusion Criteria:

(for all patients)

  • Patients who do not want to participate in the study
  • Patients younger than 18 years
  • Inadequate knowledge of the Swedish language
  • Patients with pacemaker or internal cardioverter defibrillator
  • Patients who preoperatively report continuous opioid consumption
  • Patients with chronic pain conditions
  • Patients with impaired sensibility over the dermatomes that are to be treated with TENS
  • Alcohol or substance abuse

Sites / Locations

  • Frölunda SpecialistsjukhusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

TENS (transcutaneous electrical nerve stimulation)

Conventional treatment with iv opioid

Control

Arm Description

High frequency, high intensity TENS treatment. Patients who report postoperative pain intensity according to NRS (numeric rating scale) ≥ 3 during the time spent in post-anesthesia care unit.

Patients who report postoperative pain intensity according to NRS (numeric rating scale) ≥ 3 during the time spent in post-anesthesia care unit.

Patients who report postoperative pain intensity according to NRS (numeric rating scale) < 3 during the time spent in post-anesthesia care unit.

Outcomes

Primary Outcome Measures

Time spent in post-anesthesia care unit
Time spent in post-anesthesia care unit in minutes after laparoscopic cholecystectomy.

Secondary Outcome Measures

PAIN NRS
Pain intensity according to numeric rating scale (score from 0 to 10, where 0 is described as "no pain" and 10 as "worst pain imaginable") with regard to postoperative pain.

Full Information

First Posted
April 23, 2019
Last Updated
October 5, 2020
Sponsor
Göteborg University
Collaborators
Vastra Gotaland Region
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1. Study Identification

Unique Protocol Identification Number
NCT04114149
Brief Title
Effective Postoperative Pain Relief After Laparoscopic Cholecystectomy With TENS
Official Title
Effective Postoperative Pain Relief After Laparoscopic Cholecystectomy With TENS (Transcutaneous Electrical Nerve Stimulation) Treatment for First Line of Treatment Compared to Conventional Treatment With Opioids
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Recruiting
Study Start Date
March 19, 2019 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
Vastra Gotaland Region

4. Oversight

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

5. Study Description

Brief Summary
The study evaluates the effect of TENS (transcutaneous electrical nerve stimulation) treatment for first line of treatment compared with conventional treatment with opioids on pain relief and time spent time in the post-anesthesia care unit after laparoscopic cholecystectomy. Half of the patients are randomized to TENS as first line of treatment and the second half is randomized to conventional opioid treatment. Patients who does not report postoperative pain which requires treatment are used as controls.
Detailed Description
Postoperative pain is often a problem after laparoscopic cholecystectomy. Conventional treatment with intravenous (iv) opioids often offers satisfactory pain relief. However, opioids have negative side effects, such as sedation, nausea, and respiratory depression. Some of these side effects require monitoring of the patient, resulting in longer duration of stay in the post-anesthesia care unit (PACU) after surgery. Transcutaneous electrical nerve stimulation (TENS) has been used to provide pain relief in various postoperative pain conditions. Previous studies from the investigator's center indicate that TENS treatment for postoperative pain after gynecological surgery results in shorter time in the PACU. Previous studies indicate that patients reporting pain intensity associated with venous cannulation to > 2 VAS (visual analog scale) units have higher risk of postoperative pain in the PACU. The aim of the study is to compare time spent in the PACU and to compare the postoperative pain relieving effect of high frequency, high intensity TENS as first line of treatment with conventional treatment with iv opioids in patients undergoing laparoscopic cholecystectomy. Furthermore, the study evaluates if postoperative opioid consumption can be reduced by using TENS as first line of treatment. In addition, the study tests if pain intensity associated with venous cannulation can be used to predict occurrence of postoperative pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Pain, Transcutaneous Electric Nerve Stimulation, Analgesics, Opioid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
166 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TENS (transcutaneous electrical nerve stimulation)
Arm Type
Active Comparator
Arm Description
High frequency, high intensity TENS treatment. Patients who report postoperative pain intensity according to NRS (numeric rating scale) ≥ 3 during the time spent in post-anesthesia care unit.
Arm Title
Conventional treatment with iv opioid
Arm Type
Active Comparator
Arm Description
Patients who report postoperative pain intensity according to NRS (numeric rating scale) ≥ 3 during the time spent in post-anesthesia care unit.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients who report postoperative pain intensity according to NRS (numeric rating scale) < 3 during the time spent in post-anesthesia care unit.
Intervention Type
Device
Intervention Name(s)
TENS (transcutaneous electrical nerve stimulation)
Intervention Description
TENS as first line of treatment. If insufficient pain relief, i.e. postoperative pain intensity according to NRS (numeric rating scale) ≥ 3 after two treatment sessions à 1 minute, the patient receives conventional treatment with iv opioids.
Intervention Type
Drug
Intervention Name(s)
iv opioid
Intervention Description
Conventional treatment with iv opioid if postoperative pain intensity according to NRS (numeric rating scale) ≥ 3.
Primary Outcome Measure Information:
Title
Time spent in post-anesthesia care unit
Description
Time spent in post-anesthesia care unit in minutes after laparoscopic cholecystectomy.
Time Frame
Up to 24 hours after surgery
Secondary Outcome Measure Information:
Title
PAIN NRS
Description
Pain intensity according to numeric rating scale (score from 0 to 10, where 0 is described as "no pain" and 10 as "worst pain imaginable") with regard to postoperative pain.
Time Frame
Continuous assesment during the time spent in post-anesthesia care unit, up to 24 hours after surgery
Other Pre-specified Outcome Measures:
Title
Time to pain relief
Description
Time (in minutes) from debut of postoperative pain intensity ≥ 3 according to numeric rating scale (score from 0 to 10, where 0 is described as "no pain" and 10 as "worst pain imaginable") with regard to postoperative pain, to pain relief defined as pain intensity according to numeric rating scale <3.
Time Frame
From debut of pain to pain relief, as defined above, during the time spent in post-anesthesia care unit, up to 24 hours after surgery
Title
Consumption of analgesics
Description
Consumption of analgesics during the time spent in post-anesthesia care unit
Time Frame
Assesment during the time spent in post-anesthesia care unit, up to 24 hours after surgery
Title
Patient treatment satisfaction according to NRS
Description
Self-reported treatment satisfaction with regard to pain relief, how acceptable the patient finds the treatment and hospital care. Numeric rating scale (score from 0 to 10, where 0 is described as "not satisfied at all" and 10 as "very satisfied") and numeric rating scale (score from 0 to 10, where 0 is described as "not acceptable at all" and 10 as "very acceptable").
Time Frame
Assesment at end of post-anesthesia care unit stay, up to 24 hours after surgery
Title
Patient treatment satisfaction according to NRS
Description
Self-reported treatment satisfaction with regard to pain relief, how acceptable the patient finds the treatment and hospital care. Numeric rating scale (score from 0 to 10, where 0 is described as "not satisfied at all" and 10 as "very satisfied") and numeric rating scale (score from 0 to 10, where 0 is described as "not acceptable at all" and 10 as "very acceptable").
Time Frame
1 day after surgery
Title
Patient treatment satisfaction according to NRS
Description
Self-reported treatment satisfaction with regard to pain relief, how acceptable the patient finds the treatment and hospital care. Numeric rating scale (score from 0 to 10, where 0 is described as "not satisfied at all" and 10 as "very satisfied") and numeric rating scale (score from 0 to 10, where 0 is described as "not acceptable at all" and 10 as "very acceptable").
Time Frame
7 days after surgery
Title
Time spent in hospital
Description
Time spent in hospital in hours in relation to undergoing laparoscopic cholecystectomy.
Time Frame
From arrival at the post-anesthesia care unit to end of hospital stay, an average of 1-2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: For randomized patients: • Patients who reports postoperative pain intensity ≥ 3 according to numeric rating scale during the stay in the post-anesthesia care unit after laparoscopic cholecystectomy. For controls: • Patients who reports postoperative pain intensity <3 according to numeric rating scale during the stay in the post-anesthesia care unit after laparoscopic cholecystectomy Exclusion Criteria: (for all patients) Patients who do not want to participate in the study Patients younger than 18 years Inadequate knowledge of the Swedish language Patients with pacemaker or internal cardioverter defibrillator Patients who preoperatively report continuous opioid consumption Patients with chronic pain conditions Patients with impaired sensibility over the dermatomes that are to be treated with TENS Alcohol or substance abuse
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paulin Andréll, MD, PhD
Phone
+46-31-3438259
Email
paulin.andrell@gu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Cecilia Ögren, RN
Phone
+46-31-3425000
Email
cecilia.ogren@vgregion.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulin Andréll, MD, PhD
Organizational Affiliation
Göteborgs Universitet/Västra Götalands Regionen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Frölunda Specialistsjukhus
City
Göteborg
State/Province
Västra Götalands Regionen
ZIP/Postal Code
421 44
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paulin Andréll, MD, PhD
Phone
+46-31-38259
First Name & Middle Initial & Last Name & Degree
Cecilia Ögren, RN
Phone
+46-31-3425000
Email
cecilia.ogren@vgregion.se

12. IPD Sharing Statement

Plan to Share IPD
No

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Effective Postoperative Pain Relief After Laparoscopic Cholecystectomy With TENS

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