Not provided
Not provided
Not provided
Not provided
The investigator decided not to continue the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study attempts to learn about the effectiveness of a modification to the Transversus Abdominis Plane (TAP) block that works by anaesthetizing the sensory afferents of the abdominal wall postoperatively using ultrasound guidance. The investigators want to see if regional blocks placed by the surgeon intraoperatively to assure regional anesthetic spread in the appropriate plane could reduce error and improve postoperative recovery.
This study is a prospective, randomized blinded study that investigates the efficacy of a transversus abdominis plane block under direct view. In this pilot study involving gynecologic patients undergoing open (abdominal wall incision either vertically or horizontally) hysterectomy or other related gynecologic surgery, the investigators will use ropivacaine versus saline for the placebo control group, which in both groups involves injection of agent directly into the appropriate fascial layers prior to abdominal wall closure. Efficacy is to be assessed via measurement of pain scores, nausea and vomiting, and opioid consumption in both participant groups. The number of dermatomes which are blocked in both participant groups during the first 24 hours following surgery will be recorded.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Study participants will undergo intraoperative transversus abdominis plane (TAP) block with the syringe of medication supplied by the pharmacy using a syringe with attached spinal needle between the transversus abdominis and internal oblique. The spinal needle will be threaded horizontally and as far laterally at the superior aspect of the vertical axis of the incision as possible within this space and anesthetic will be injected after an initial pull back on the syringe to ensure there is no arterial exposure as per the following schedule: Weight <70kg: Ropivacaine 75mg - 150 mg on each side (20mL ropivacaine 3.75mg/ml each side) Weight greater than or equal to 70kg: Ropivacaine 100mg - 200mg on each side (20mL ropivacaine 5mg/ml each side |
|
| Group B | Placebo Comparator | Study participants will undergo intraoperative transversus abdominis plane (TAP) block with the syringe of medication supplied by the pharmacy using a syringe with attached spinal needle between the transversus abdominis and internal oblique. The spinal needle will be threaded horizontally and as far laterally at the superior aspect of the vertical axis of the incision as possible within this space and the placebo solution will be injected after an initial pull back on the syringe to ensure there is no arterial exposure as per the following schedule: Weight <70kg: 20mL each side Weight greater than or equal to 70kg: 20mL each side |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Milligrams of Diludid Consumption During First 48 hours Following Surgery | The amount of diludid received per participant will be recorded from participant medication record at the specified time frame. | 48 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Nerve (Dermatome) Block | The investigator will complete dermatomal assessments at the specified time frames by using a stimulus in the area of the transversus abdominis plane block to determine the effectiveness of the block. | 4hrs postoperative and on postoperative day 1 |
| Pain Scores at Rest and with Movement |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Transversus Abdominis Plane Block | Procedure |
|
Pain severity will be measured using a validated Numerical Rating Scale with 0cm=no pain and 10cm=worst pain imaginable. |
| 2, 4, 6, 12, 24, 36 and 48 hours postoperatively. |
| Postoperative Nausea and Vomiting | Nausea will be measured using a validated postoperative nausea and vomiting scale known as the Impact Scale. | 2, 4, 6, 12, 24, 36 and 48 hours postoperatively. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |
| D000588 |
| Amines |