Effective Postoperative Pain Relief After Laparoscopic Cholecystectomy With TENS

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: iv opioid; Device: TENS (transcutaneous electrical nerve stimulation)

• Registration Number: NCT04114149
• Lead Sponsor: Göteborg University

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).

Study Timeline

• Study Start: 2019-03-19
• Study First Submitted: 2019-04-23
• Study First Submitted QC: 2019-10-02
• Study First Posted: 2019-10-03
• Primary Completion: 2023-01-23
• Study Completion: 2023-01-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional treatment with iv opioid	iv opioid	Patients who report postoperative pain intensity according to NRS (numeric rating scale) ≥ 3 during the time spent in post-anesthesia care unit.
TENS (transcutaneous electrical nerve stimulation)	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.

Primary Outcome Measures

Name	Time	Method
Time spent in post-anesthesia care unit	Up to 24 hours after surgery	Time spent in post-anesthesia care unit in minutes after laparoscopic cholecystectomy.

Secondary Outcome Measures

Name	Time	Method
PAIN NRS	Continuous assesment during the time spent in post-anesthesia care unit, up to 24 hours after surgery	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.

Trial Locations

Locations (1)

Frölunda Specialistsjukhus; 🇸🇪 Göteborg, Västra Götalands Regionen, Sweden