Anesthesia, Pain, Postoperative
Conditions
Keywords
recovery, postoperative, pain, laparoscopy, hysterectomy, ropivacaine, TAP block, local anesthesia
Brief summary
The Transversus Abdominal Plane (TAP) block has been used with good success to decrease postoperative pain following laparatomy. If the TAP block provides any improvement in the quality of recovery following laparoscopic hysterectomy, it could decrease the need for postoperative narcotics and allow for more outpatient hysterectomy procedures.
Interventions
DRUGTAP Block
Bilateral transversus abdominal plane injection under ultrasound guidance, done at conclusion of hysterectomy procedure, prior to emergence from general anesthesia
Sponsors
MetroHealth Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Any patient undergoing laparoscopic hysterectomy * Age ranges 18-80 * Reading literacy * English speaking * Able to give informed consent
Exclusion criteria
* History of relevant drug allergy * Chronic opioid users who may have tolerance to pain medications * Inability to understand written consent forms or give consent * Age less than 18 or over 80 * Any conversion to open surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery Questionnaire (QoR-40) on Postop Day #1 or #2 | Postop Day #1 or Day #2 | 40 question survey completed on paper or by telephone on post-operative day #1 or #2, designed to measure health status after surgery and anesthesia. Scale ranges from 40 (extremely poor qualify of recovery) to 200 (excellent quality of recovery). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Narcotic Use | Postop Day #0 and Day #1 | narcotic use in mg of Morphine will be recorded |
| Visual Analog Scale (VAS) for Pain | 2 and 24 hours post operative | visual analogue scales for pain will be completed on post-operative day #0 and #1, pain is assessed on a 10-point visual analogue scale (0 = no pain; 1 to 3 = mild; 4 to 6 = moderate pain; 7 to 10 = severe pain.) |
| Intraoperative Time | the total intraoperative time in minutes | The total time in the operating room will be recorded to see if there is a difference between groups. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tap Block Patients randomized to either Tap Block or No Tap Block | 28 |
| No Block Patients randomized to either Tap Block or No Tap Block | 28 |
| Total | 56 |
Baseline characteristics
| Characteristic | Total | No Block | Tap Block |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 56 Participants | 28 Participants | 28 Participants |
| Sex: Female, Male Female | 56 Participants | 28 Participants | 28 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 28 |
| other Total, other adverse events | 0 / 28 | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
Primary
Quality of Recovery Questionnaire (QoR-40) on Postop Day #1 or #2
40 question survey completed on paper or by telephone on post-operative day #1 or #2, designed to measure health status after surgery and anesthesia. Scale ranges from 40 (extremely poor qualify of recovery) to 200 (excellent quality of recovery).
Time frame: Postop Day #1 or Day #2
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAP Block | Quality of Recovery Questionnaire (QoR-40) on Postop Day #1 or #2 | 168.0 units on a scale |
| No Block | Quality of Recovery Questionnaire (QoR-40) on Postop Day #1 or #2 | 169.5 units on a scale |
Secondary
Intraoperative Time
The total time in the operating room will be recorded to see if there is a difference between groups.
Time frame: the total intraoperative time in minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAP Block | Intraoperative Time | 47.4 Minutes |
| No Block | Intraoperative Time | 34.5 Minutes |
Secondary
Narcotic Use
narcotic use in mg of Morphine will be recorded
Time frame: Postop Day #0 and Day #1
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TAP Block | Narcotic Use | Post operative day #0 | 11.7 mg of morphine |
| TAP Block | Narcotic Use | Post operative day #1 | 7.5 mg of morphine |
| No Block | Narcotic Use | Post operative day #0 | 11.8 mg of morphine |
| No Block | Narcotic Use | Post operative day #1 | 9.0 mg of morphine |
Secondary
Visual Analog Scale (VAS) for Pain
visual analogue scales for pain will be completed on post-operative day #0 and #1, pain is assessed on a 10-point visual analogue scale (0 = no pain; 1 to 3 = mild; 4 to 6 = moderate pain; 7 to 10 = severe pain.)
Time frame: 2 and 24 hours post operative
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TAP Block | Visual Analog Scale (VAS) for Pain | 2 hours post operative | 5.0 units on a scale |
| TAP Block | Visual Analog Scale (VAS) for Pain | 24 hours post operative | 5.0 units on a scale |
| No Block | Visual Analog Scale (VAS) for Pain | 2 hours post operative | 6.0 units on a scale |
| No Block | Visual Analog Scale (VAS) for Pain | 24 hours post operative | 5.0 units on a scale |