Effective Postoperative Pain Relief After Laparoscopic Cholecystectomy With TENS

NCT ID: NCT04114149

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-19
• Study Completion Date: 2023-01-30

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).

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

TENS (transcutaneous electrical nerve stimulation)

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

iv opioid

Intervention Type: DRUG

Conventional treatment with iv opioid if postoperative pain intensity according to NRS (numeric rating scale) ≥ 3.

Control

Patients who report postoperative pain intensity according to NRS (numeric rating scale) \< 3 during the time spent in post-anesthesia care unit.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

iv opioid

Conventional treatment with iv opioid if postoperative pain intensity according to NRS (numeric rating scale) ≥ 3.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: collaborator

Göteborg University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paulin Andréll, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Göteborgs Universitet/Västra Götalands Regionen

Locations

Frölunda Specialistsjukhus

Gothenburg, Västra Götalands Regionen, Sweden

Countries

Sweden

References

Angelini E, Josefsson C, Ogren C, Andrell P, Wolf A, Ringdal M. Patients experiences of TENS as a postoperative pain relief method in the post-anesthesia care unit after laparoscopic cholecystectomy: a qualitative study. BMC Anesthesiol. 2025 Jan 9;25(1):18. doi: 10.1186/s12871-024-02872-4.

Reference Type: DERIVED

PMID: 39789467 (View on PubMed)

Other Identifiers

VGFOUREG-832941/ 249891

Identifier Type: -

Identifier Source: org_study_id