Preoperative Capsaicin Patch Treatment to Reduce Pain and Pain Sensitivity After Surgery
NCT07922525, Phase 4, Completed, Burkhard Gustorff
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Preoperative Capsaicin Patch Treatment to Reduce Pain and Pain Sensitivity After Surgery | ClinicalTrials.gov |
| NCT number | NCT07922525 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 63 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Burkhard Gustorff | ClinicalTrials.gov |
| Conditions | Postoperative Pain, Hyperalgesia | ClinicalTrials.gov |
| Interventions | Capsaicin 8% cutaneous patch, Vehicle patch without capsaicin | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
| Other registries' IDs | eudract:2015-003208-22 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Mechanical pain sensitivity around the incision on postoperative day 1 | Postoperative day 1 (24 +/- 4 hours after surgery) | Mean pain rating in response to seven weighted pinprick stimuli (8, 16, 32, 64, 128, 256 and 512 mN) applied in the area of secondary mechanical hyperalgesia around the surgical incision. Ratings use a numerical rating scale from 0 (no pain) to 100 (most intense pain imaginable); higher values indicate greater mechanical pain sensitivity. | ClinicalTrials.gov |
| Secondary | Clinical postoperative pain | Postoperative days 1, 2, 3 and 7 | Pain intensity assessed using a numerical rating scale from 0 (no pain) to 100 (most intense pain imaginable), including pain at rest, during movement, average pain since the previous day and worst pain since the previous day. Higher scores indicate greater pain. | ClinicalTrials.gov |
| Secondary | Immediate postoperative pain in the recovery unit | First 90 minutes after surgery and recovery-unit discharge | Mean and maximum pain intensity during the first 90 minutes in the post-anesthesia care unit, with pain assessments at 15-minute intervals and at discharge. Numerical rating scale from 0 (no pain) to 100 (most intense pain imaginable); higher scores indicate greater pain. | ClinicalTrials.gov |
| Secondary | Postoperative opioid consumption | Postoperative days 1, 2 and 3 | Daily postoperative opioid consumption, including patient-controlled analgesia, converted to morphine equivalents. | ClinicalTrials.gov |
| Secondary | Mechanical pain sensitivity on postoperative days 3 and 7 | Postoperative days 3 and 7 | Mean numerical pain ratings (0 = no pain; 100 = most intense pain imaginable) to weighted pinprick stimuli of 8, 16, 32, 64, 128, 256 and 512 mN in the area of secondary hyperalgesia around the incision. Higher values indicate greater pain sensitivity. | ClinicalTrials.gov |
| Secondary | Electrically evoked pain at the incision | Postoperative days 1, 3 and 7 | Pain rating during electrical stimulation at the incision using a stimulus intensity of 10 times the baseline electrical detection threshold. Numerical rating scale from 0 (no pain) to 100 (most intense pain imaginable); higher scores indicate greater pain. | ClinicalTrials.gov |
| Secondary | Area of secondary mechanical hyperalgesia | Postoperative days 1, 3 and 7 | Area around the incision with increased pain sensitivity, mapped using a 256 mN pinprick stimulus to identify the boundary of secondary hyperalgesia. | ClinicalTrials.gov |
| Secondary | Pressure pain threshold at a remote site | Preoperative baseline and postoperative days 1, 3 and 7 | Pressure pain threshold measured over the tibia using a handheld pressure algometer with a 1 cm2 probe. Mean of three measurements; higher thresholds indicate lower pressure pain sensitivity. | ClinicalTrials.gov |
| Secondary | Heat pain threshold | Preoperative baseline and day of surgery before incision | Temperature at which a warming thermode is first perceived as painful. Thermode baseline temperature 32 degrees Celsius, heating rate 1 degree Celsius per second; mean of two measurements. Higher thresholds indicate lower heat pain sensitivity. | ClinicalTrials.gov |
| Secondary | Suprathreshold heat pain | Preoperative baseline and day of surgery before incision | Pain rating in response to a 50 degrees Celsius heat stimulus with a 4-second plateau, rated on a numerical rating scale from 0 (no pain) to 100 (most intense pain imaginable). Mean of two measurements; higher scores indicate greater heat pain sensitivity. | ClinicalTrials.gov |
| Secondary | Conditioned pain modulation | Preoperative baseline | Change in pressure pain threshold and heat pain ratings during a conditioning cold-water stimulus. A hand is immersed in water at 3-4 degrees Celsius for up to 60 seconds or until pain reaches 80 on a 0-100 numerical rating scale. The response characterizes endogenous pain modulation. | ClinicalTrials.gov |
| Secondary | Persistent postoperative pain | 1, 2 and 6 months after surgery | Presence and intensity of pain at the surgical site assessed by telephone using a numerical rating scale from 0 (no pain) to 100 (most intense pain imaginable). A score greater than 0 indicates persisting pain; higher values indicate greater pain intensity. | ClinicalTrials.gov |
| Secondary | Cutaneous nerve fiber density | During surgery after preoperative patch treatment | Histological analysis of an approximately 3 x 3 mm skin biopsy taken at the incision site during surgery, including immunohistochemical assessment of cutaneous nerve fibers and TRPV1-expressing fibers. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)