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| Name | Class |
|---|---|
| Vastra Gotaland Region | OTHER_GOV |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Continuous assesment during the time spent in post-anesthesia care unit, up to 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time to pain relief | 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. | 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 |
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)
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| Name | Affiliation | Role |
|---|---|---|
| Paulin Andréll, MD, PhD | Göteborgs Universitet/Västra Götalands Regionen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frölunda Specialistsjukhus | Gothenburg | Västra Götalands Regionen | 421 44 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39789467 | Derived | 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. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000701 | Analgesics, Opioid |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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|
| iv opioid | Drug | Conventional treatment with iv opioid if postoperative pain intensity according to NRS (numeric rating scale) ≥ 3. |
|
| Consumption of analgesics | Consumption of analgesics during the time spent in post-anesthesia care unit | Assesment during the time spent in post-anesthesia care unit, up to 24 hours after surgery |
| Patient treatment satisfaction according to NRS | 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"). | Assesment at end of post-anesthesia care unit stay, up to 24 hours after surgery |
| Patient treatment satisfaction according to NRS | 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"). | 1 day after surgery |
| Patient treatment satisfaction according to NRS | 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"). | 7 days after surgery |
| Time spent in hospital | Time spent in hospital in hours in relation to undergoing laparoscopic cholecystectomy. | From arrival at the post-anesthesia care unit to end of hospital stay, an average of 1-2 days |
| D012816 | Signs and Symptoms |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |