N/A
N=64
Remote Ischemic PreConditioning Effect on Postsurgical Pain
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01383317 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Comparison of Pain Intensity and Unpleasantness Postoperatively — 4.82; 4.83; 4.05; 4.81 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1) (Device); Sham RIPC (Device)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Pain Intensity and Unpleasantness Postoperatively |
4.82; 4.83; 4.05; 4.81 | — |
| SECONDARY Number of Participants That Consumed Opioids |
20; 24; 19; 22 | — |
| SECONDARY Consumption of Nonopioid Analgesics |
19; 18; 17; 21 | — |
| SECONDARY Use of Antiemetics |
25; 21 | — |
| SECONDARY Level of Sedation |
2.29; 2.15; 2.11; 1.95 | — |
| SECONDARY McGill Pain Sensory |
11.71; 12.73; 7.14; 12.82 | — |
| SECONDARY Leg Pain at 48 Hours |
4; 1 | — |
| SECONDARY Patient Verbal Assessment as to Whether They Received Active Treatment or Placebo |
20; 20; 1; 0; 2; 0 | — |
| SECONDARY Pain Unpleasantness |
4.43; 5.18; 3.52; 4.54 | — |
Summary
Remote Ischemic PreConditioning (RIPC) will improve the postoperative pain experience in patients undergoing abdominal surgery. Although abdominal surgery can be a lifesaving procedure many people have a significant amount of postsurgical pain. Severe postsurgical pain may lead to chronic pain in some people. "Remote Ischemic Preconditioning" may reduce the amount of postsurgical pain. Remote ischemic preconditioning is done by inflating a balloon (very similar to a blood pressure cuff) on the leg until it blocks blood flow for a few minutes. The cuff is then deflated and blood flow resumes. The process is repeated up to three times. This procedure causes the body to increase its natural pain relief system that may help to decrease the amount of postsurgical pain.
Eligibility Criteria
Inclusion Criteria
- Ages 30-80
- Undergoing elective open intra-peritoneal surgery
- Able to provide written informed consent to participate
- Laparoscopic abdominal surgery
Exclusion Criteria
- Ongoing Workman's Compensation claim
- >50mg/day of oral morphine or morphine equivalent
- Currently being treated for lower extremity DVT
- Known intracranial hypertension (not excluding patients with a functioning VP shunt)
- Known Hypercoagulable state (e.g. factor V Leiden, protein s or c deficiency)
- Ongoing localized thigh pain
- Planned epidural analgesia
- Pregnancy
- Any DSM IV-R Axis I psychotic disorders
- Unable to understand English
- Unable to understand the consent form
Data sourced from ClinicalTrials.gov (NCT01383317). 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.