Continuous Infusion of Local Anesthetic for Optimal Post Operative Pain Control Following Hemorrhoidectomy
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| ClinicalTrials.gov Identifier: NCT01099605 |
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Recruitment Status : Unknown
Verified April 2010 by United States Naval Medical Center, Portsmouth.
Recruitment status was: Recruiting
First Posted : April 7, 2010
Last Update Posted : April 7, 2010
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Over the past decade, continuous wound infiltration systems have been introduced to treat a variety of post-surgical pain. These systems, commonly referred to pain pumps by patients, possess a catheter(s) attached to a reservoir of local anesthetic that directly infuses into the surgical site to provide local pain control thus avoiding the common and less desirable systemic effects of oral narcotic pain medication. Due to its portability, another benefit associated with these wound infiltration systems is its use as an outpatient pain control modality. Despite the apparent benefits, the verdict on the system's effectiveness in treating pain - throughout a variety of surgical fields - varies between very effective in reducing post-operative pain and reducing overall narcotic consumption for several days to completely ineffective with no reported changes in perceived pain or overall narcotic use.
Through a randomized trial comparing plain saline to a common local anesthetic, The investigators hope to evaluate the effectiveness of these pain pumps as an outpatient modality for pain management following hemorrhoidectomy patients. The investigators hypothesize that there will be a significant benefit in pain relief with the use of these pumps.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hemorrhoids | Device: placement of a continuous infusion pump Device: continuous infusion pump of bupivacaine | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 42 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Continuous Infusion of Local Anesthetic for Optimal Post Operative Pain Control Following Hemorrhoidectomy: A Randomized Double-blind Controlled Trial |
| Study Start Date : | April 2010 |
| Estimated Primary Completion Date : | April 2012 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Pump device
One arm will have continuous subcutaneous infusion of normal saline.
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Device: placement of a continuous infusion pump
Each infusion pump is placed below the mucosa of the rectum. Infusion of either the drug or saline will continue for approximately 3-4 days. |
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Active Comparator: Bupivacaine
will receive continuous infusion of bupivacaine
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Device: continuous infusion pump of bupivacaine
bupivacaine 0.25% at 4ml/hr for 3 to 4 days |
- VAS pain scales [ Time Frame: 1 week ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Patients scheduled for hemorrhoidectomies at NMCP
Exclusion Criteria:
- Any patient with co-existing active purulent infection (i.e. abscess).
- Any patient who has had previous surgical intervention for his/her hemorrhoidal disease. Previous simple incision to treat a thrombosed hemorrhoid is not considered a surgical intervention for the purposes of this study. The minimal scar produced by a small incision would not alter post-operative pain following removal of a hemorrhoidal column.
- Any patient allergic to local anesthetics or oral pain medications
- Any patient with a history of chronic pain
- Any patient allergic to or has had an adverse reaction (i.e. history of gastrointestinal bleed) to a non-steroidal anti-inflammatory drugs (NSAIDs)
- Any patient pregnant patient
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01099605
| Contact: Ellie Mentler, MD | 757-953-2454 | ellie.mentler@med.navy.mil |
| United States, Virginia | |
| Naval Medical Center Portsmouth | Recruiting |
| Portsmouth, Virginia, United States, 23708 | |
| Contact: Ellie Mentler, MD 757-314-0134 ellie.mentler@med.navy.mil | |
| Principal Investigator: Ellie Mentler, MD | |
| Responsible Party: | LT Ellie K Mentler, MC USN, NavalMCPortsmouth |
| ClinicalTrials.gov Identifier: | NCT01099605 |
| Other Study ID Numbers: |
CIP# 10.0042 |
| First Posted: | April 7, 2010 Key Record Dates |
| Last Update Posted: | April 7, 2010 |
| Last Verified: | April 2010 |
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hemorrhoidectomy pain management |
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Hemorrhoids Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
Vascular Diseases Cardiovascular Diseases Bupivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |