Ultrasound-guided Transversus Abdominis Plane Block After Hysterectomy
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

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.
    

Intervention name(s): TAP block
Intervention type(s): Procedure
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Postoperative pain, TAP block, Hysterectomy