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Clinical Trials/NCT01153503
NCT01153503
Completed
Not Applicable

Ultrasound-guided Transversus Abdominis Plane Block After Abdominal Hysterectomy: a Prospective Randomized Controlled Trial

University of Texas Southwestern Medical Center1 site in 1 country75 target enrollmentApril 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post Operative Pain
Sponsor
University of Texas Southwestern Medical Center
Enrollment
75
Locations
1
Primary Endpoint
Morphine Consumption
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 2010
End Date
December 2011
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Irina Gasanova

ASSOC PROFESSOR

University of Texas Southwestern Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Morphine Consumption

Time Frame: 24 hours post surgery

Morphine consumption over the first 24 hours

Study Sites (1)

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