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NCT Number: NCT04114149

Effective Postoperative Pain Relief After Laparoscopic Cholecystectomy With TENS

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Frölunda Specialistsjukhus

Gothenburg, Västra Götalands Regionen, 421 44, Sweden

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

IV opioid

Drug

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

Primary outcomes

  1. Time spent in post-anesthesia care unit

    Time frame: Up to 24 hours after surgery

    Time spent in post-anesthesia care unit in minutes after laparoscopic cholecystectomy.

Secondary outcomes

  1. PAIN NRS

    Time frame: 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.

Other outcomes

  1. Time to pain relief

    Time frame: 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

    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.

  2. Consumption of analgesics

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

    Consumption of analgesics during the time spent in post-anesthesia care unit

  3. Patient treatment satisfaction according to NRS

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

    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").

  4. Patient treatment satisfaction according to NRS

    Time frame: 1 day after surgery

    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").

  5. Patient treatment satisfaction according to NRS

    Time frame: 7 days after surgery

    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").

  6. Time spent in hospital

    Time frame: From arrival at the post-anesthesia care unit to end of hospital stay, an average of 1-2 days

    Time spent in hospital in hours in relation to undergoing laparoscopic cholecystectomy.

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Vastra Gotaland Region

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 3, 2019
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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