Pain, PostoperativeNCT04114149
Effective Postoperative Pain Relief After Laparoscopic Cholecystectomy With TENS
A study testing TENS (transcutaneous electrical nerve stimulation) and iv opioid in people with Pain, Postoperative, run by Göteborg University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- TENS (transcutaneous electrical nerve stimulation) and iv opioid
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteSweden
- Study dates
- 19 Mar 2019to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- (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
Show all 9Show fewer
- Patients with chronic pain conditions
- Patients with impaired sensibility over the dermatomes that are to be treated with TENS
- Alcohol or substance abuse
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Frölunda Specialistsjukhus
Gothenburg, Västra Götalands Regionen, 421 44
About this study
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
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.
Read the 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
- Being tested
- TENS (transcutaneous electrical nerve stimulation), iv opioid
- Keywords
- Pain, Transcutaneous Electric Nerve Stimulation, Analgesics, Opioid
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 opioidDrug
Conventional treatment with iv opioid if postoperative pain intensity according to NRS (numeric rating scale) ≥ 3.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent in post-anesthesia care unit
Time spent in post-anesthesia care unit in minutes after laparoscopic cholecystectomy.
Measured: Up to 24 hours after surgery
Secondary outcomes (1)
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.
Measured: Continuous assesment during the time spent in post-anesthesia care unit, up to 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start19 Mar 2019
- Primary completion23 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Vastra Gotaland Region
- Responsible party
- Sponsor
- Investigators
- Paulin Andréll, MD, PhD, Principal investigator, Göteborgs Universitet/Västra Götalands Regionen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114149
- Sponsor's protocol ID
- VGFOUREG-832941/ 249891
- Status last verified
- May 2025
- First submitted
- 23 Apr 2019
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39789467
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04114149
- Acronym / sponsor ID
- VGFOUREG-832941/ 249891
- Conditions
- Pain, Postoperative
- Keywords
- Pain, Transcutaneous Electric Nerve Stimulation, Analgesics, Opioid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Vastra Gotaland Region
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 23 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TENS (transcutaneous electrical nerve stimulation) | Active comparator | Device: 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. |
| Conventional treatment with iv opioid | Active comparator | Drug: iv opioidPatients who report postoperative pain intensity according to NRS (numeric rating scale) ≥ 3 during the time spent in post-anesthesia care unit. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who reports postoperative pain intensity ≥ 3 according to numeric rating scale during the stay in the post-anesthesia care unit after laparoscopic cholecystectomy.
- Patients who reports postoperative pain intensity <3 according to numeric rating scale during the stay in the post-anesthesia care unit after laparoscopic cholecystectomy
Key exclusion criteria (9 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | TENS (transcutaneous electrical nerve stimulation) |
| iv opioidConventional treatment with iv opioid if postoperative pain intensity according to NRS (numeric rating scale) ≥ 3. | Drug | Conventional treatment with iv opioid |
Primary outcome
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.
1 secondary outcome
PAIN NRS
Time frame: Continuous assesment during the time spent in post-anesthesia care unit, up to 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Derived from this study: PubMed 39789467Angelini 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paulin Andréll, MD, PhD principal investigator
Göteborgs Universitet/Västra Götalands Regionen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS (transcutaneous electrical nerve stimulation) and iv opioid in people with Pain, Postoperative, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time spent in post-anesthesia care unit (time frame: Up to 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04114149, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.