Ultrasound-guided Transversus Abdominis Plane Block After Hysterectomy (TAP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Irina Gasanova, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01153503
First received: June 28, 2010
Last updated: March 18, 2014
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Post Operative Pain
Procedure: TAP block
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Ultrasound-guided Transversus Abdominis Plane Block After Abdominal Hysterectomy: a Prospective Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Morphine Consumption [ Time Frame: 24 hours post surgery ] [ Designated as safety issue: No ]
    Morphine consumption over the first 24 hours


Enrollment: 75
Study Start Date: April 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ketorolac 30 mg, IV + TAP block

Ketorolac 30 mg, IV + Bilateral ultrasound-guided TAP blocks at the end of the surgery

First 24-h Postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine

24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn

Procedure: TAP block

Group Intraoperative (at the end of surgery): Ketorolac 30 mg, IV + TAP block; TAP block

First 24-h Postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine

24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn

Active Comparator: TAP block

Intraoperative (at the end of surgery): Bilateral ultrasound-guided TAP block at the end of the surgery

First 24-h Postoperative: IV-PCA morphine

24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn

Procedure: TAP block

Group Intraoperative (at the end of surgery): Ketorolac 30 mg, IV + TAP block; TAP block

First 24-h Postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine

24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn

No Intervention: Ketorolac 30 mg

Intraoperative (at the end of surgery): Ketorolac 30 mg, IV at the end of the surgery.

First 24-h Postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h +IV-PCA morphine.

24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn


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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153503

Locations
United States, Texas
UTSW Parkland Health Hospital System
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Irina Gasanova, MD University of Texas Southwestern Medical Center
  More Information

No publications provided by University of Texas Southwestern Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Irina Gasanova, ASSOC PROFESSOR, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01153503     History of Changes
Other Study ID Numbers: 022010-002
Study First Received: June 28, 2010
Results First Received: March 18, 2014
Last Updated: March 18, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Acetaminophen
Acetaminophen, hydrocodone drug combination
Ketorolac
Ketorolac Tromethamine
Analgesics
Analgesics, Non-Narcotic
Analgesics, Opioid
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Central Nervous System Agents
Central Nervous System Depressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014