Postoperative Pain
Conditions
Keywords
Pain, Post Operative, Opioids, Laparoscopic, Surgery, Hysterectomy
Brief summary
The transversus abdominis plane (TAP) block involves the sensory nerve supply of the anterior -lateral abdominal wall where the T7-12 intercostal nerves, ilioinguinal, iliohypogastric and the lateral cutaneous branches of the dorsal rami of L1-3 are blocked with an injection of local anesthetic between the internal oblique abdominal muscle (IOAM) and the transverse abdominal muscle(TAM)This technique allows sensory blockade of the anterolateral abdominal wall via local anesthetic deposition superficial to the transversus abdominis muscle. It was first described by McDonnell et al. as a landmark technique to provide analgesia for lower abdominal surgery. Hebbart et al. subsequently described an ultrasound guided technique for the TAP block which they named posterior TAP block. The ultrasound allows identification of the external oblique abdominal muscles (EOAM),IOAM and TAM. Previous studies about ultrasound -guided regional anesthetic techniques suggest improved block quality and safety, which is primarily due to direct visualization of the relevant anatomy, the tip of the needle, and the spread of the local anesthetics. Clinical trials of the single shot posterior TAP block have shown a significant reduction in morphine consumption during the first 24-36 hours after surgery. More recently, El-dawlatly et al. demonstrated that ultrasound guided TAP block in patients undergoing laparoscopic cholecystectomy reduced perioperative opioid consumption by more than 50%. This is the first study to evaluate the effect of TAP block in the quality of recovery in patients undergoing laparoscopic hysterectomy and may help the pathway to make this an outpatient procedure.
Interventions
DRUGPlacebo
placebo injection
DRUGDrug .5% Ropivacaine
.5% ropivacaine 20 mls on each side of abdomen
DRUG20 cc of 0.25% ropivacaine
Will receive a bilateral TAP block using 20 cc of 0.25% ropivacaine
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18-64 years * Surgery: Laparoscopic Hysterectomy surgery * ASA status: I and II * Fluent in English
Exclusion criteria
* History of allergy to local anesthetics * History of chronic opioid use * Pregnant patients * BMI greater than 30 Drop-out criteria: * Patient or surgeon request * Complications related to the procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QoR40 on the Day After Surgery | 1 day | QoR40 on the day after surgery. Quality of recovery is based on a score of 40-200. 40 being a poor recovery and 200 being a good recovery score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 24 Total Morphine Consumption | 1 day | Total 24 total morphine consumption post operative. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Group B (control group) will receive sterile normal saline. | 25 |
| Study Drug Group A (study group) 20 cc of 0.5% ropivacaine | 25 |
| 20 cc of 0.25% Ropivacaine Active Comparator 2. 20 cc of 0.25% ropivacaine | 25 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Change to open surgical procedure | 1 | 3 | 4 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Study Drug | 20 cc of 0.25% Ropivacaine | Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 25 Participants | 25 Participants | 75 Participants |
| Age, Continuous | 45.4 years STANDARD_DEVIATION 4.5 | 46.76 years STANDARD_DEVIATION 6.4 | 47.4 years STANDARD_DEVIATION 9.6 | 46.55 years STANDARD_DEVIATION 7.2 |
| Region of Enrollment United States | 25 participants | 25 participants | 25 participants | 75 participants |
| Sex: Female, Male Female | 25 Participants | 25 Participants | 25 Participants | 75 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 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
Primary
QoR40 on the Day After Surgery
QoR40 on the day after surgery. Quality of recovery is based on a score of 40-200. 40 being a poor recovery and 200 being a good recovery score.
Time frame: 1 day
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| PLACEBO | QoR40 on the Day After Surgery | 152 units on a scale | Inter-Quartile Range 22.8 |
| 20 cc of 0.5% Ropivacaine | QoR40 on the Day After Surgery | 180 units on a scale | Inter-Quartile Range 12.16 |
| 20 cc of 0.25% Ropivacaine | QoR40 on the Day After Surgery | 180 units on a scale | Inter-Quartile Range 15.3 |
p-value: 0.05Kruskal-Wallis
p-value: 0.0595% CI: [9, 37]Dunns test
p-value: 0.0595% CI: [14, 42]Dunns Test
Secondary
24 Total Morphine Consumption
Total 24 total morphine consumption post operative.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PLACEBO | 24 Total Morphine Consumption | 22.75 miligrams of morphine | Standard Deviation 10.75 |
| 20 cc of 0.5% Ropivacaine | 24 Total Morphine Consumption | 12.5 miligrams of morphine | Standard Deviation 9.84 |
| 20 cc of 0.25% Ropivacaine | 24 Total Morphine Consumption | 17.5 miligrams of morphine | Standard Deviation 13.07 |
p-value: 0.05Kruskal-Wallis
p-value: 0.00395% CI: [3, 15]Dunns test
p-value: 0.1495% CI: [-1, 12]Dunns test