N/A
N=99
Cryoanalgesia to Prevent Acute and Chronic Pain Following Surgery: A Randomized, Double-Masked, Sham-Controlled Study
Mastectomy · Upper Limb Amputation Below Elbow · Upper Limb Amputation Above Elbow · Lower Limb Amputation Below Knee · Lower Limb Amputation Above Knee
Bottom Line
View on ClinicalTrials.gov: NCT03578237 ↗Enrolled (actual)
99
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Average Pain (Mastectomy Subjects Only) — 0.0; 3.0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cryoneurolysis (active) (Device); Sham cryoneurolysis procedure (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Pain (Mastectomy Subjects Only) |
0.0; 3.0 | — |
| SECONDARY Analgesic Consumption |
1.2; 3.3; 1.0; 4.1; .8; 3.2 | — |
| SECONDARY Brief Pain Inventory (Interference Subscale) |
0; 4.1; 0; 0.6; 0; 1.1 | — |
| SECONDARY Worst Pain Measured on the 11 Point Numeric Rating Scale |
3.7; 5.5; 3.3; 5.6; 2.8; 5.1 | — |
| SECONDARY Average Pain Measured on the 11 Point Numeric Rating Scale |
1.5; 3.2; 1.5; 3.3; 1.2; 2.8 | — |
| SECONDARY Difficultly Sleeping Due to Pain |
5; 11; 6; 11; 6; 13 | — |
| SECONDARY Number of Awakenings |
0.1; .8; .3; .5; .4; .9 | — |
| SECONDARY Nausea |
.5; .6; .1; .3; 0; 0.3 | — |
| SECONDARY Phantom Pain Occurences [Mastectomy & Amputation] |
0; 0.5; 0; 9.8; 0; 4.0 | — |
| SECONDARY Phantom Pain Duration [Mastectomy & Amputation] |
0; 0.1; 0; 0; 0; 5.1 | — |
| SECONDARY Phantom Sensation Occurrences [Mastectomy & Amputation] |
0; 0; 0; 1.2; 0; 0.5 | — |
| SECONDARY Phantom Sensation Duration [Mastectomy & Amputation] |
0; 0; 0; 0.1; 0; 1.7 | — |
| SECONDARY Residual Limb or Wound Pain Occurences |
0.9; 20; 0; 4.4; 0.1; 5.3 | — |
| SECONDARY Residual Limb or Wound Pain Duration |
0.1; 17.6; 0; 3.5; 0; 5.3 | — |
Summary
The ultimate objective of the proposed line of research is to determine if cryoanalgesia is an effective adjunctive treatment for pain in the period immediately following various painful surgical procedures; and, if this analgesic modality decreases the risk of persistent postoperative pain, or "chronic" pain. The objective of the proposed pilot study is to optimize the protocol and collect data to power subsequent, definitive clinical trials.
Specific Aim 1: To determine if, compared with current and customary analgesia, the addition of cryoanalgesia decreases the incidence and severity of post-surgical pain.
Hypothesis 1a (primary): The severity of surgically-related pain will be significantly decreased on postoperative day 2 with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment.
Hypothesis 1b: The incidence of chronic pain will be significantly decreased one year following surgery with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment.
Hypothesis 1c: The severity of chronic pain will be significantly decreased one year following surgery with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment.
Specific Aim 2: To determine if, compared with current and customary analgesia, the addition of cryoanalgesia improves postoperative functioning.
Hypothesis 2a: Following primary unilateral knee and shoulder arthroplasty as well as rotator cuff repair, joint range of motion will be significantly increased within the year following surgery with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment.
Hypothesis 2b: Following video-assisted thoracoscopic surgery, inspiratory spirometry will be improved within the month following surgery with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment.
Eligibility Criteria
Inclusion Criteria
- adult patients of at least 18 years of age
- scheduled for a primary, unilateral total knee or shoulder arthroplasty, primary unilateral rotator cuff repair, VATS procedure, skin grafting of the lateral thigh, unilateral or bilateral mastectomy, or limb amputation distal to the femoral/humeral head and including at least one metatarsal/metacarpal bone
- single-injection or continuous peripheral nerve blocks block or epidural infusion planned for perioperative analgesia
- accepting of a cryoneurolysis procedure
Exclusion Criteria
- chronic opioid use (daily use within the 2 weeks prior to surgery and duration of use > 4 weeks)
- pregnancy
- incarceration
- inability to communicate with the investigators
- morbid obesity (body mass index > 40 kg/m2)
- possessing any contraindication specific to cryoneurolysis such as a localized infection at the treatment site, cryoglobulinemia, cold urticaria and Reynaud's Syndrome
Data sourced from ClinicalTrials.gov (NCT03578237). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.