Clinical trial NCT04114149: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: Pain
Transcutaneous Electric Nerve Stimulation
Analgesics, Opioid
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
First posted: 2019-10-03
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Addmendment after study registration:

166 participants were randomized in the RCT part of the study. In the observational part of the study (investigating if pain intensity associated with venous cannulation can be used to predict occurrence of postoperative pain) 258 participants were included. The ethical application (approval number 954-18) covers both parts of the study (i.e. RCT and observaltional study).

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

Primary outcomes:
measure: Time spent in post-anesthesia care unit
timeFrame: Up to 24 hours after surgery
Secondary outcomes:
measure: PAIN NRS
timeFrame: Continuous assesment during the time spent in post-anesthesia care unit, up to 24 hours after surgery
Other outcomes:
measure: Time to pain relief
timeFrame: 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
measure: Consumption of analgesics
timeFrame: Assesment during the time spent in post-anesthesia care unit, up to 24 hours after surgery
measure: Patient treatment satisfaction according to NRS
timeFrame: Assesment at end of post-anesthesia care unit stay, up to 24 hours after surgery
measure: Patient treatment satisfaction according to NRS
timeFrame: 1 day after surgery
measure: Patient treatment satisfaction according to NRS
timeFrame: 7 days after surgery
measure: Time spent in hospital
timeFrame: From arrival at the post-anesthesia care unit to end of hospital stay, an average of 1-2 days
Locations:
city: Göteborg
country: Sweden
facility: Frölunda Specialistsjukhus
state: Västra Götalands Regionen
Study officials:
affiliation: Göteborgs Universitet/Västra Götalands Regionen
name: Paulin Andréll, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: