A Phase 4 interventional study of Capsaicin 8% cutaneous patch and Vehicle patch without capsaicin in Postoperative Pain and Hyperalgesia, sponsored by Burkhard Gustorff. Completed at 2 sites in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Burkhard Gustorff · Phase 4, Interventional, and Prevention
This study investigated whether applying an 8% capsaicin patch to the skin at a planned trocar incision site before abdominal laparoscopic surgery changes postoperative pain and pain sensitivity. Adults were randomly assigned to continued capsaicin treatment or a vehicle control patch after both groups received a brief initial capsaicin application to support blinding. The main comparison was pain in response to standardized pinprick stimuli on the first day after surgery. Other assessments included clinical pain, pain medicine use, mechanical, heat, pressure and electrical sensitivity, endogenous pain modulation, and skin nerve fibers. Telephone follow-up was performed at 1, 2 and 6 months after surgery.
This randomized, double-blind, placebo-controlled, parallel-group phase 4 study evaluated whether preoperative desensitization of TRPV1-expressing nociceptive fibers reduces postoperative hyperalgesia and pain. The participants actually enrolled underwent abdominal laparoscopic surgery.
Participants were randomized 1:1 using computer-generated block randomization. Both groups received an initial 10-minute application of an 8% capsaicin patch at the planned incision site. A second patch was then applied for 9 hours 50 minutes: capsaicin 8% in the experimental group or a visually matched vehicle patch without capsaicin in the control group. Total treatment duration was 10 hours, including the initial 10 minutes. Incision was scheduled 24 hours after the start of patch application. Study patches were prepared by the hospital pharmacy and applied by authorized study personnel.
Participants and study personnel assessing outcomes were blinded to allocation. The randomization code was held by the study leader in sealed storage without inspection until unblinding after the final participant had completed the study.
The primary outcome was mean pain intensity in response to seven weighted pinprick stimuli in the area of secondary mechanical hyperalgesia around the incision on postoperative day 1 (24 +/- 4 hours after surgery), assessed using a numerical rating scale from 0 (no pain) to 100 (most intense pain imaginable). Additional assessments included clinical pain, opioid consumption, the area of secondary hyperalgesia, electrical, pressure and heat sensitivity, conditioned pain modulation, and intraoperative skin biopsy for nerve fiber analysis. Telephone follow-up was performed at 1, 2 and 6 months.
This record is being prepared retrospectively after study completion. The study was previously registered in the European Union Clinical Trials Register under EudraCT number 2015-003208-22. The original 48-hour treatment regimen was amended to a total treatment duration of 10 hours. A subsequent amendment replaced the previously planned low-dose capsaicin active placebo with the initial 10-minute capsaicin 8% application in both groups, followed by continued capsaicin or vehicle treatment; this amendment was acknowledged without objection by the Ethics Committee of the City of Vienna on March 21, 2023. The regimen described in this record reflects the treatment actually administered. The study was self-funded.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 63 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →This is the only study on the registry with Burkhard Gustorff as lead sponsor.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Capsaicin 8% patch (Qutenza) applied over the planned incision site on the day before surgery. Both groups received an initial 10-minute capsaicin application. In this arm, a second capsaicin 8% patch was applied for a further 9 hours 50 minutes, giving a total treatment duration of 10 hours. Incision was scheduled 24 hours after the start of patch application. Cooling was available for application-site discomfort.
Drug: Capsaicin 8% cutaneous patch
Initial 10-minute application of a capsaicin 8% patch, followed by a visually matched vehicle patch without capsaicin for 9 hours 50 minutes, giving a total treatment duration of 10 hours. The vehicle patch was prepared by the hospital pharmacy. Treatment covered the planned incision site; incision was scheduled 24 hours after the start of patch application. The brief initial capsaicin exposure was used to support blinding.
Drug: Capsaicin 8% cutaneous patch · Drug: Vehicle patch without capsaicin
Topical capsaicin 8% patch (Qutenza), cut to cover the planned surgical incision. Both groups received an initial capsaicin application for 10 minutes. The experimental group then received a second capsaicin 8% patch for 9 hours 50 minutes (total capsaicin treatment: 10 hours); the control group instead received a vehicle patch for 9 hours 50 minutes. Incision was scheduled 24 hours after the start of patch application.
Visually matched vehicle patch without capsaicin, prepared by the hospital pharmacy. In the control arm, it was applied after an initial 10-minute capsaicin 8% application and remained in place for 9 hours 50 minutes, giving a total treatment duration of 10 hours. Incision was scheduled 24 hours after the start of patch application.
Mechanical pain sensitivity around the incision on postoperative day 1
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.
Time frame: Postoperative day 1 (24 +/- 4 hours after surgery)
Clinical postoperative pain
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.
Time frame: Postoperative days 1, 2, 3 and 7
Immediate postoperative pain in the recovery unit
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.
Time frame: First 90 minutes after surgery and recovery-unit discharge
Postoperative opioid consumption
Daily postoperative opioid consumption, including patient-controlled analgesia, converted to morphine equivalents.
Time frame: Postoperative days 1, 2 and 3
Mechanical pain sensitivity on 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.
Time frame: Postoperative days 3 and 7
Electrically evoked pain at the incision
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.
Time frame: Postoperative days 1, 3 and 7
Area of secondary mechanical hyperalgesia
Area around the incision with increased pain sensitivity, mapped using a 256 mN pinprick stimulus to identify the boundary of secondary hyperalgesia.
Time frame: Postoperative days 1, 3 and 7
Pressure pain threshold at a remote site
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.
Time frame: Preoperative baseline and postoperative days 1, 3 and 7
Heat pain threshold
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.
Time frame: Preoperative baseline and day of surgery before incision
Suprathreshold heat pain
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.
Time frame: Preoperative baseline and day of surgery before incision
Conditioned pain modulation
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.
Time frame: Preoperative baseline
Persistent postoperative pain
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.
Time frame: 1, 2 and 6 months after surgery
Cutaneous nerve fiber density
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.
Time frame: During surgery after preoperative patch treatment
Plan to share: No
Ran from Feb 2023 to primary completion in Nov 2025, 33 months.
Of 531 non-industry phase 4 interventional studies under Pain, Postoperative, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 32. This study's 33 months is above that.
Counting every sponsor, half of 541 studies reached it within 16 months; a quarter within 8 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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