Remote Ischemic PreConditioning Effect on Postsurgical Pain

Pain Clinical Trial

— RIPCEPP  

Official title:

Remote Ischemic Preconditioning (RIPC) and Its Effect on the Postoperative Pain Experience Following Intra-abdominal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01383317
• Other study ID #: 00016978
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: April 30, 2017

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 30, 2017
• Est. primary completion date: April 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Ages 30-80

2. Undergoing elective open intra-peritoneal surgery

3. Able to provide written informed consent to participate

4. Laparoscopic abdominal surgery

Exclusion Criteria:

1. Ongoing Workman's Compensation claim

2. >50mg/day of oral morphine or morphine equivalent

3. Currently being treated for lower extremity DVT

4. Known intracranial hypertension (not excluding patients with a functioning VP shunt)

5. Known Hypercoagulable state (e.g. factor V Leiden, protein s or c deficiency)

6. Ongoing localized thigh pain

7. Planned epidural analgesia

8. Pregnancy

9. Any DSM IV-R Axis I psychotic disorders

10. Unable to understand English

11. Unable to understand the consent form

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1)
Disposable sterile thigh tourniquet
• Sham RIPC
Disposable sterile thigh tourniquet

Locations

Country	Name	City	State
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Pain Intensity and Unpleasantness Postoperatively	Pain intensity and unpleasantness will be measured on postoperative day (POD) 1 and 2 by using a 0-10 verbal scale after asking the subject to cough. Higher scores denotes more intensity and unpleasantness of pain.	Postoperative day 1 and postoperative day 2
Secondary	Number of Participants That Consumed Opioids	All opioids administered during postoperative day (POD) 1 and 2 will be recorded and the number of participants that used opioids will be given.	Postoperative day 1 and postoperative day 2
Secondary	Consumption of Nonopioid Analgesics	All non-opioids analgesics administered during postoperative day 1 and 2 will be recorded and the number of participants that used nonopiods will be given.	Postoperative day 1 and postoperative day 2
Secondary	Use of Antiemetics	Number of participants that used an antiemetic postoperative day 1 and postoperative day 2 was recorded.	Postoperative day 1 and postoperative day 2
Secondary	Level of Sedation	The Ramsey Sedation Scale (RSS) was used to determine the level of sedation. Th RSS defines the conscious state from a level 1: the patient is anxious, agitated or restless, through the continuum of sedation to a level 6: the patient is completely unresponsive. The score range is from 1-6, with higher scores denoting worse outcomes.	Postoperative day 1 and postoperative day 2
Secondary	McGill Pain Sensory	The McGill Pain Questionnaire (MPQ) is a three-part pain assessment tool that measures several dimensions of the patient's pain experience. The scale range is 0-78, with higher scores denoting worse outcomes.	Postoperative day 1 and postoperative day 2
Secondary	Leg Pain at 48 Hours	Number of participants that had leg pain at 48 hours.	postoperative day 2
Secondary	Patient Verbal Assessment as to Whether They Received Active Treatment or Placebo	Participants were questioned to see if they knew what interventional group they belonged to.	Postoperative day 1 and postoperative day 2
Secondary	Pain Unpleasantness	Pain unpleasantness will be measured on postoperative day (POD) 1 and 2 by using a 0-10 verbal scale after asking the subject to cough. Higher scores denotes more intensity and unpleasantness of pain.	Postoperative day 1 and postoperative day 2