Effective Postoperative Pain Relief After Laparoscopic Cholecystectomy With TENS

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Device: TENS (transcutaneous electrical nerve stimulation)
* Drug: iv opioid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TENS (transcutaneous electrical nerve stimulation)<br>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)<br>* 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.<br>|
| Active Comparator: Conventional treatment with iv opioid<br>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<br>* Conventional treatment with iv opioid if postoperative pain intensity according to NRS (numeric rating scale) ≥ 3.<br>|
| No Intervention: Control<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Transcutaneous Electric Nerve Stimulation, Analgesics, Opioid