Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A01016-43 | Other Identifier | Numéro ID-RCB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The key to early surgery recovery lies in optimal and immediate control of postoperative pain. Despite standard pain management protocols, lung resection is often associated with acute, neuropathic, or chronic pain, compounded by the side effects of morphine-based treatments. In this context, aromatherapy can provide complementary support, both to alleviate pain and to improve the quality of recovery after surgery.
Lung cancer is the leading cause of cancer mortality in France. Lung resection is the standard treatment for early-stage or locally advanced non-small cell lung cancer, but it remains a very painful procedure with a high risk of complications and a morbidity rate of around 30%. Enhanced Recovery After Surgery (ERAS) protocols have reduced morbidity and mortality through standardized perioperative care. Early and optimal pain control is essential to promote rapid mobilization, limit complications, and prevent chronicity. Despite multimodal management, acute, neuropathic, and chronic pain remain common after lung resection and impair the quality of recovery.
Complementary approaches, such as aromatherapy, are increasingly used to support conventional treatments, sometimes reducing the use of morphine derivatives and their adverse effects. Lavender (Lavandula angustifolia) essential oil and its main components, linalool and linalyl acetate, whose antinociceptive, anti-inflammatory, and anxiolytic properties are well documented, is of particular interest. Our study will evaluate the effect of daily application of 5% lavender essential oil (AromaQoR) to the skin around the surgical wound for three days following surgery on improving the quality of recovery.
The surgeon preselects eligible patients and the coordinating nurse ("IDEC") presents the study to them during a preoperative interview. The day before surgery, the IDEC obtains consent, has the QoR-15F completed, and performs an AromaQoR skin test. On the morning of surgery, only patients without allergic reactions are included and then randomized into two groups: placebo (PL) or intervention (AT). From D0 to D2, the intervention (placebo or AromaQoR) is applied every evening, while the QoR-15F questionnaire is collected daily by a different team. Pain scores (EN, DN4) are measured regularly, with only those taken the following morning being recorded, and all rescue analgesics are recorded. A post-operative consultation is conducted three weeks after discharge, during which the IDEC measures the EN and DN4 and collects the QoR-15F questionnaire completed by the patient. This consultation marks the end of follow-up for the trial.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PL =placebo | Placebo Comparator | The PL group: In addition to standard pain relief treatments, the PL group will receive topical application of sweet almond oil around the operated area at 9 p.m. from day 0 to day 2. |
|
| AT = aromatherapy | Experimental | The AT group: in addition to standard analgesic treatments, the AT group will receive topical application of the "AromaQoR" formulation, containing lavender essential oil (Lavandula angustifolia) diluted to 5% in sweet almond vegetable oil around the operated area at 9 p.m. from day 0 to day 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| topical application of the "AromaQoR" formulation | Other | topical application of the "AromaQoR" formulation, containing lavender essential oil (Lavandula angustifolia) diluted to 5% in sweet almond vegetable oil around the operated area |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the total QoR-15F | Change in the total QoR-15F score (Recovery Quality score) on postoperative day 2 (measured in the evening, as it assesses, among other things, activity during the day) compared to the baseline value obtained the day before surgery, day -1, between the two groups. | day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the total QoR-15F score (Recovery Quality) on postoperative Day 1 (evening) | Change in the total QoR-15F score (Recovery Quality) on postoperative D1 (evening) compared to the baseline value on Day-1 | Day 1 |
| Change in the total QoR-15F score (Recovery Quality) on postoperative Day 3 (evening) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| claudia Lavedan | Contact | 5 67 77 18 74 | +33 | lavedan.c@chu-toulouse.fr |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| topical application of sweet almond vegetable oil | Other | topical application of sweet almond oil around the operated area |
|
Change in the total QoR-15F score (Recovery Quality) on postoperative Day 3 (evening) compared to the baseline value on Day-1 |
| Day 3 |
| Change in the total QoR-15F score 3 weeks after discharge (postoperative consultation) | Change in the total QoR-15F score 3 weeks after discharge (postoperative consultation) compared to the baseline value on D-1 | Week 3 |
| Change in pain score at Day 0 (= day of surgery) | pain score measured by numerical scale (EN) at each measurement time point compared to Day-1 | Day 0 |
| Change in pain score at from postoperative Day 1 to postoperative Day 3 (morning, evening, night) | pain score measured by numerical scale (EN) at each measurement time point compared to Day-1 | Day 3 |
| Change in pain score at 3 weeks after discharge (day of postoperative consultation). | pain score measured by numerical scale (EN) at each measurement time point compared to Day-1 | week 3 |
| Quantification of the consumption of Nefopam | number of ampoules consumed per day. | day 3 |
| Quantification of the consumption of morphine derivatives (prescribed as a second-line treatment if Nefopam is ineffective) | number of tablets consumed per day | day 3 |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided