Erector Spinae Plane Block Versus Transverse Abdominis Plane Block in Laparoscopic Hysterectomy
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Indiana University
- Enrollment
- 78
- Locations
- 2
- Primary Endpoint
- Visual Analogue Scale (VAS) Pain Scores at Rest at 48 Hours.
Study Overview
Brief Summary
The purpose of this study is to compare the difference between two different pain control methods in patients who will be having a hysterectomy surgery. By collecting this data, we aim to show improved postoperative pain scores, decreased opioid needs, and decreased opioid side effects (nausea, sedation, ileus, urinary retention, respiratory depression).
Detailed Description
For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected. [10]
For the ESP block, as mentioned previously, the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected.
All patients will receive PO acetaminophen and PO gabapentin the morning of surgery. Pt. will be placed on PRN oxycodone/acetaminophen (Percocet) postoperatively. PRN IV dilaudid may be given for severe breakthrough pain.
Opioid usage at 1, 24 and 48 hours after the block will be recorded by a member of the research team. Pain scores at rest and on movement will be measured by the investigator using Visual Analog Scale (VAS). Nausea will be measured using a categorical scoring system (none=0; mild=1; moderate=2; severe=3). Sedation scores will also be assessed by a member of the study team using a sedation scale (awake and alert=0; quietly awake=1; asleep but easily roused=2; deep sleep=3). All these parameters will be measured at 1, 24 and 48 hours after the blocks and patients will be encouraged to ambulate on postoperative day 1 under supervision. Their ambulation activity will be recorded.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Both the patients and the research staff doing assessments will be blinded to the randomization
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing laparoscopic hysterectomy surgery at Indiana University Hospital
- •ASA class 1, 2, 3 or 4
- •Age 18 or older, female
- •Desires Regional anesthesia for postoperative pain control
Exclusion Criteria
- •History of substance abuse in the past 6 months.
- •Patients on more than 30 mg morphine equivalents of opioids.
- •Any physical, mental or medical conditions which in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
- •Known allergy or other contraindications to the study medications (Acetaminophen, Gabapentin, Bupivacaine).
- •Postoperative intubation.
- •Any BMI greater than 40.0.
Arms & Interventions
ESP Block
For the ESP block the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected (40 ml into each side; 20 ml injected at T8 and 20 ml injected at T12)
Intervention: bupivacaine, 0.125% (Drug)
TAP Block
For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected (40 ml into each side; 20 ml injected for subcostal TAP and 20 ml injected for posterior TAP).
Intervention: Liposomal bupivacaine (Drug)
TAP Block
For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected (40 ml into each side; 20 ml injected for subcostal TAP and 20 ml injected for posterior TAP).
Intervention: bupivacaine, 0.125% (Drug)
ESP Block
For the ESP block the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected (40 ml into each side; 20 ml injected at T8 and 20 ml injected at T12)
Intervention: Liposomal bupivacaine (Drug)
Outcomes
Primary Outcomes
Visual Analogue Scale (VAS) Pain Scores at Rest at 48 Hours.
Time Frame: 48 hours after surgery
Visual Analogue Scale (VAS) score taken at rest measured as minimal to maximal; higher values mean worse pain(scale 0-10)
Visual Analogue Scale (VAS) Pain Scores With Movement at 1 Hour.
Time Frame: 1 hour after surgery
Visual Analogue Scale (VAS) score taken with movement is measured as minimal to maximal; higher values mean worse pain (scale 0-10)
Visual Analogue Scale (VAS) Pain Scores With Movement at 24 Hours.
Time Frame: 24 hours after surgery
Visual Analogue Scale (VAS) score taken with movement measured as minimal to maximal; higher values mean worse pain (scale 0-10)
Visual Analogue Scale (VAS) Pain Scores With Movement at 48 Hours.
Time Frame: 48 hours after surgery
Visual Analogue Scale (VAS) score taken with movement measured as minimal to maximal; higher values mean worse pain(scale 0-10)
Visual Analogue Scale (VAS) Pain Scores at Rest at 1 Hour.
Time Frame: 1 hour after surgery
Visual Analogue Scale (VAS) score taken at rest is measured as minimal to maximal; higher values mean worse pain (scale 0-10)
Visual Analogue Scale (VAS) Pain Scores at Rest at 24 Hours.
Time Frame: 24 hours after surgery
Visual Analogue Scale (VAS) score taken at rest measured as minimal to maximal; higher values mean worse pain (scale 0-10)
Secondary Outcomes
- Patient Sedation Score at 1 Hour(1 hour after surgery)
- Patient Sedation Score at 24 Hours(24 hours after surgery)
- Patient Sedation Score at 48 Hours(48 hours after surgery)
- Patient Nausea Score at 1 Hour(1 hour after surgery)
- Patient Nausea Score at 24 Hour(24 hour after surgery)
- Patient Nausea Score at 48 Hour(48 hour after surgery)
- Patient Satisfaction Score at 24 Hours(24 hours after surgery)
- Patient Satisfaction Score at 48 Hours(48 hours after surgery)
Investigators
Yar Yeap
Director, Acute Pain Service Assistant Professor of Clinical Anesthesiololgy Department of Anesthesiology
Indiana University