View Clinical Trial (Medical Research Study)
Ultrasound-guided Transversus Abdominis Plane Block After Abdominal Hysterectomy: a Prospective Randomized Controlled Trial
| City: |
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Dallas |
| State: |
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Texas |
| Zip Code: |
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75390 |
| Conditions: |
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Post Operative Pain |
| Purpose: |
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In this randomized, controlled, observer-blinded study we plan to evaluate ultrasound-guided
transversus abdominis plane (TAP) block for postoperative pain management in patients
undergoing abdominal hysterectomy.
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| Study Summary: |
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Patients undergoing abdominal hysterectomy (n=75) at Parkland Hospital will be randomized
into one of three groups to receive either ultrasound-guided bilateral TAP block with or
without NSAIDs and acetaminophen (Groups 1 and 2) or the conventional analgesic regimen
(Group 3) for postoperative pain management. The remaining aspect of perioperative care,
including the general anesthetic technique, will be standardized and similar for all
patients. The duration of the involvement in the study will be until 48 hours
postoperatively. The pre-anesthesia care unit personnel will identify patients during their
preoperative clinic visit. There will be no incentive or payment to the patients.
Patients in Group 1 and 2 will receive ultrasound-guided bilateral TAP block after surgery.
In the first 24-h postoperative period, patients in Groups 1 and 3 will receive
acetaminophen 650 mg every 6 h orally, ketorolac 30 mg every 6 h, and morphine via an
intravenous patient controlled analgesia (IV-PCA) system to maintain adequate pain control.
Patients in Group 2 will receive IV-PCA morphine for the first 24 hours in addition to the
ultrasound-guided bilateral block. In the 24-48 h study period, all patients will receive
oral ibuprofen 800 mg three times a day and a combination of hydrocodone/acetaminophen
5mg/500 mg 1-2 tablets every 6h, prn. The postoperative analgesia will be documented using
the visual analog score (0=no pain,10=worst pain). In addition, total opioid dose over the
48-h study period will be documented. Postoperative nausea will be measured using a
categorical scoring system (none=0, mild=1, moderate=2, severe=3) and episodes of vomiting
will be documented. Rescue antiemetics will be given to any patient who complains of nausea
or vomiting. All variables will be assessed at 2, 6, 12, 24, and 48 hours, postoperatively
by an investigator blinded to group allocation.
Primary endpoint will be in about 24 hours after surgery morphine consumption. The secondary
endpoints will include the VAS pain score at 6, 12, 24 and 48 hours after surgery and side
effects associated with morphine use.
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| Criteria: |
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Inclusion Criteria:
- 18-80 years old
- Female ASA physical status 1-3 scheduled for abdominal hysterectomy
- Able to participate personally or by legal representative in informed consent in
English or Spanish
Exclusion Criteria:
- History of relevant drug allergy
- Age less than 18 or greater than 80
- Chronic opioid users who may have a tolerance to opioids
- Psychiatric disturbance
- Inability to understand the study protocol procedures
- Patient refusal
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| NCT ID: |
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NCT01153503 |
| Primary Contact: |
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Irina Gasanova, MD, PhD
Phone: 214-590-0064
Email: IRINA.GASANOVA@UTSOUTHWESTERN.EDU
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| Backup Contact: |
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N/A |
| Location Contact: |
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Dallas, Texas 75390
United States
Irina Gasanova, MD, PhD
Phone: 214-590-0064
Email: IRINA.GASANOVA@UTSOUTHWESTERN.EDU
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
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