Effective Postoperative Pain Relief After Laparoscopic Cholecystectomy With TENS

NCT04114149 | Completed

• 1 other identifier: VGFOUREG-832941/ 249891
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

Pain; Transcutaneous Electric Nerve Stimulation; Analgesics, Opioid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• PAIN NRS

  Continuous assesment during the time spent in post-anesthesia care unit, up to 24 hours after surgery

Other Outcomes (6)

• Time to pain relief

  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

• Consumption of analgesics

  Assesment during the time spent in post-anesthesia care unit, up to 24 hours after surgery

• Patient treatment satisfaction according to NRS

  Assesment at end of post-anesthesia care unit stay, up to 24 hours after surgery

Study Arms (3)

TENS (transcutaneous electrical nerve stimulation)

ACTIVE COMPARATOR

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)

Conventional treatment with iv opioid

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

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

Interventions

TENS (transcutaneous electrical nerve stimulation) 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.

TENS (transcutaneous electrical nerve stimulation)

iv opioid DRUG

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

Conventional treatment with iv opioid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• (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

Sponsors & Collaborators

• Göteborg University: lead
• Vastra Gotaland Region: collaborator

Study Sites (1)

Frölunda Specialistsjukhus

Gothenburg, Västra Götalands Regionen, 421 44, Sweden

Location

Related Publications (1)

• 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.

  PMID: 39789467 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Transcutaneous Electric Nerve Stimulation; Analgesics, Opioid

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Paulin Andréll, MD, PhD

  Göteborgs Universitet/Västra Götalands Regionen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: October 3, 2019
• Study Start: March 19, 2019
• Primary Completion: January 23, 2023
• Study Completion: January 30, 2023
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)