Remote Ischemic PreConditioning Effect on Postsurgical Pain

Not Applicable

Completed

Conditions: Pain

Interventions: Device: Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1)
Device: Sham RIPC

Registration Number: NCT01383317

Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 64

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RIPC	Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1)	A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times
Sham RIPC	Sham RIPC	A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times

Primary Outcome Measures

Name	Time	Method
Comparison of Pain Intensity and Unpleasantness Postoperatively	Postoperative day 1 and postoperative day 2	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.

Secondary Outcome Measures

Name	Time	Method
Use of Antiemetics	Postoperative day 1 and postoperative day 2	Number of participants that used an antiemetic postoperative day 1 and postoperative day 2 was recorded.
Consumption of Nonopioid Analgesics	Postoperative day 1 and postoperative day 2	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.
Number of Participants That Consumed Opioids	Postoperative day 1 and postoperative day 2	All opioids administered during postoperative day (POD) 1 and 2 will be recorded and the number of participants that used opioids will be given.
Leg Pain at 48 Hours	postoperative day 2	Number of participants that had leg pain at 48 hours.
Patient Verbal Assessment as to Whether They Received Active Treatment or Placebo	Postoperative day 1 and postoperative day 2	Participants were questioned to see if they knew what interventional group they belonged to.
Level of Sedation	Postoperative day 1 and postoperative day 2	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.
McGill Pain Sensory	Postoperative day 1 and postoperative day 2	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.
Pain Unpleasantness	Postoperative day 1 and postoperative day 2	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.