Post Operative Pain
Conditions
Keywords
Postoperative pain, TAP block, Hysterectomy
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.
Interventions
PROCEDURETAP 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
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Consumption | 24 hours post surgery | Morphine consumption over the first 24 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ketorolac 30 mg, IV + TAP Block Bilateral ultrasound-guided TAP block at the end of the surgery
First 24-h postoperative: Ketorolac 30 mg, IV, every 6h + acetaminophen 650 mg, orally, every 6h + IV-PCA morphine | 25 |
| TAP Block Bilateral ultrasound-guided TAP block at the end of the surgery+ IV-PCA morphine
First 24-h postoperative: IV-PCA morphine | 24 |
| Ketorolac 30 mg IV Ketorolac 30 mg, IV at the end of surgery
First 24-h postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine | 25 |
| Total | 74 |
Baseline characteristics
| Characteristic | Ketorolac 30 mg, IV + TAP Block | TAP Block | Ketorolac 30 mg IV | Total |
|---|---|---|---|---|
| Age, Continuous | 42.4 years STANDARD_DEVIATION 5.4 | 43.8 years STANDARD_DEVIATION 6.5 | 43.1 years STANDARD_DEVIATION 5.6 | 43.1 years STANDARD_DEVIATION 5.8 |
| Region of Enrollment United States | 25 participants | 24 participants | 25 participants | 74 participants |
| Sex: Female, Male Female | 25 Participants | 24 Participants | 25 Participants | 74 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 24 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 24 | 0 / 25 |
Outcome results
Primary
Morphine Consumption
Morphine consumption over the first 24 hours
Time frame: 24 hours post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac 30 mg, IV + TAP Block | Morphine Consumption | 38.4 mg | Standard Deviation 25.7 |
| TAP Block | Morphine Consumption | 38.6 mg | Standard Deviation 26.8 |
| Ketorolac 30 mg | Morphine Consumption | 42.6 mg | Standard Deviation 31.2 |