Effective Postoperative Pain Relief After Laparoscopic Cholecystectomy With TENS

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04114149
• Other study ID #: VGFOUREG-832941/ 249891
• Status: Recruiting
• Phase: N/A
• Start date: March 19, 2019
• Est. completion date: March 2024

Study information

• Verified date: October 2020
• Source: Göteborg University
• Contact: Paulin Andréll, MD, PhD
• Phone: +46-31-3438259
• Email: paulin.andrell[@]gu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: March 2024
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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.

Drug:
• iv opioid
Conventional treatment with iv opioid if postoperative pain intensity according to NRS (numeric rating scale) = 3.

Locations

Country	Name	City	State
Sweden	Frölunda Specialistsjukhus	Göteborg	Västra Götalands Regionen

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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