Effective Postoperative Pain Relief After Laparoscopic Cholecystectomy With TENS

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative
• Intervention / Treatment: Device: TENS (transcutaneous electrical nerve stimulation); Drug: iv opioid

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.

• Study Type: Interventional
• Enrollment (Anticipated): 166
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Västra Götalands Regionen
    • Göteborg, Västra Götalands Regionen, Sweden, 421 44
      • Recruiting
      • Frölunda Specialistsjukhus
      • Contact: Paulin Andréll, MD, PhD; Phone Number: +46-31-38259

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TENS (transcutaneous electrical nerve stimulation); 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.	Device: TENS (transcutaneous electrical nerve stimulation); 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.
Active Comparator: Conventional treatment with iv opioid; Patients who report postoperative pain intensity according to NRS (numeric rating scale) ≥ 3 during the time spent in post-anesthesia care unit.	Drug: iv opioid; Conventional treatment with iv opioid if postoperative pain intensity according to NRS (numeric rating scale) ≥ 3.
No Intervention: Control; Patients who report postoperative pain intensity according to NRS (numeric rating scale) < 3 during the time spent in post-anesthesia care unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time spent in post-anesthesia care unit	Time spent in post-anesthesia care unit in minutes after laparoscopic cholecystectomy.	Up to 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Continuous assesment during the time spent in post-anesthesia care unit, up to 24 hours after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to pain relief	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.	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
Consumption of analgesics	Consumption of analgesics during the time spent in post-anesthesia care unit	Assesment during the time spent in post-anesthesia care unit, up to 24 hours after surgery
Patient treatment satisfaction according to NRS	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").	Assesment at end of post-anesthesia care unit stay, up to 24 hours after surgery
Patient treatment satisfaction according to NRS	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").	1 day after surgery
Patient treatment satisfaction according to NRS	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").	7 days after surgery
Time spent in hospital	Time spent in hospital in hours in relation to undergoing laparoscopic cholecystectomy.	From arrival at the post-anesthesia care unit to end of hospital stay, an average of 1-2 days

Collaborators and Investigators

• Sponsor: Göteborg University
• Collaborators: Vastra Gotaland Region
• Investigators: Principal Investigator: Paulin Andréll, MD, PhD, Göteborgs Universitet/Västra Götalands Regionen

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2019
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: October 2, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Actual): October 6, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Pain; Transcutaneous Electric Nerve Stimulation; Analgesics, Opioid
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: VGFOUREG-832941/ 249891

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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