HysterectomyPhase 3NCT04003987
ESP Block VS TAP in Laparoscopic Hysterectomy
A Phase 3 study testing Liposomal bupivacaine and bupivacaine, 0.125% in people with Hysterectomy, run by Indiana University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- Liposomal bupivacaine and bupivacaine, 0.125%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2019to 4 Mar 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana Univeristy
Indianapolis, Indiana, 46202
Indiana University Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Erector Spinae Plane Block Versus Transverse Abdominis Plane Block in Laparoscopic Hysterectomy
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).
Read the 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.
- Conditions
- Hysterectomy
- Being tested
- Liposomal bupivacaine, bupivacaine, 0.125%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
Also called Exparel
20ml
bupivacaine, 0.125%Drug
Also called bupivacaine
60ml
| Study group | Role | What they receive |
|---|---|---|
| ESP Block | Active comparator | 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) Receives: Drug: Liposomal bupivacaine; Drug: bupivacaine, 0.125% |
| TAP Block | Active comparator | 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). Receives: Drug: Liposomal bupivacaine; Drug: bupivacaine, 0.125% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) Pain Scores at Rest at 1 Hour.
Visual Analogue Scale (VAS) score taken at rest is measured as minimal to maximal; higher values mean worse pain (scale 0-10)
Measured: 1 hour after surgery
Visual Analogue Scale (VAS) Pain Scores at Rest at 24 Hours.
Visual Analogue Scale (VAS) score taken at rest measured as minimal to maximal; higher values mean worse pain (scale 0-10)
Measured: 24 hours after surgery
Visual Analogue Scale (VAS) Pain Scores at Rest at 48 Hours.
Visual Analogue Scale (VAS) score taken at rest measured as minimal to maximal; higher values mean worse pain(scale 0-10)
Measured: 48 hours after surgery
Visual Analogue Scale (VAS) Pain Scores With Movement at 1 Hour.
Visual Analogue Scale (VAS) score taken with movement is measured as minimal to maximal; higher values mean worse pain (scale 0-10)
Measured: 1 hour after surgery
Visual Analogue Scale (VAS) Pain Scores With Movement at 24 Hours.
Visual Analogue Scale (VAS) score taken with movement measured as minimal to maximal; higher values mean worse pain (scale 0-10)
Measured: 24 hours after surgery
Visual Analogue Scale (VAS) Pain Scores With Movement at 48 Hours.
Visual Analogue Scale (VAS) score taken with movement measured as minimal to maximal; higher values mean worse pain(scale 0-10)
Measured: 48 hours after surgery
Secondary outcomes (8)
Patient Sedation Score at 1 Hour
Sedation is measured as minimum to maximum awareness/level of consciousness; higher values means worse or less awareness (awake, asleep but arousable, deep sleep)
Measured: 1 hour after surgery
Patient Sedation Score at 24 Hours
Sedation is measured as minimum to maximum aware ness/level of consciousness: higher values means worse or less awareness (awake, asleep but arousable, deep sleep)
Measured: 24 hours after surgery
Patient Sedation Score at 48 Hours
Sedation is measured as minimum to maximum awareness/level of consciousness; higher values means worse or less awareness (awake, asleep but arousable, deep sleep)
Measured: 48 hours after surgery
Patient Nausea Score at 1 Hour
Nausea is measured as minimum to maximum: higher values is worse (none, mild, moderate, severe)
Measured: 1 hour after surgery
Patient Nausea Score at 24 Hour
Nausea is measured as minimum to maximum: higher values is worse (none, mild, moderate, severe)
Measured: 24 hour after surgery
Patient Nausea Score at 48 Hour
Nausea is measured as minimum to maximum: higher values is worse (none, mild, moderate, severe)
Measured: 48 hour after surgery
Patient Satisfaction Score at 24 Hours
patient satisfaction is measured as minimum to maximum 1-5; the higher the score the better satisfied (very unsatisfied, unsatisfied, neutral, satisfied, very satisfied)
Measured: 24 hours after surgery
Patient Satisfaction Score at 48 Hours
patient satisfaction is measured as minimum to maximum 1-5; the higher the score the better satisfied (very unsatisfied, unsatisfied, neutral, satisfied, very satisfied)
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start1 May 2019
- Primary completion4 Mar 2021
- Study completion4 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. ESP Block Group 2. TAP Block Group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yar Yeap, Indiana University
- Investigators
- Yar Yeap, MD, Principal investigator, Indiana University HospitalMatthew Warner, MD, Principal investigator, Indiana University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003987
- Sponsor's protocol ID
- 1903977303
- Status last verified
- Jun 2022
- First submitted
- 23 May 2019
- Last updated
- 5 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shaffer EE, Pham A, Woldman RL, Spiegelman A, Strassels SA, Wan GJ, Zimmerman T. Estimating the Effect of Intravenous Acetaminophen for Postoperative Pain Management on Length of Stay and Inpatient Hospital Costs. Adv Ther. 2017 Jan;33(12):2211-2228. doi: 10.1007/s12325-016-0438-y. Epub 2016 Nov 9.
PubMed 27830448Routman HD, Israel LR, Moor MA, Boltuch AD. Local injection of liposomal bupivacaine combined with intravenous dexamethasone reduces postoperative pain and hospital stay after shoulder arthroplasty. J Shoulder Elbow Surg. 2017 Apr;26(4):641-647. doi: 10.1016/j.jse.2016.09.033. Epub 2016 Nov 15.
PubMed 27856266Bacal V, Rana U, McIsaac DI, Chen I. Transversus Abdominis Plane Block for Post Hysterectomy Pain: A Systematic Review and Meta-Analysis. J Minim Invasive Gynecol. 2019 Jan;26(1):40-52. doi: 10.1016/j.jmig.2018.04.020. Epub 2018 Apr 30.
PubMed 29723644Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.
PubMed 30292068Petsas D, Pogiatzi V, Galatidis T, Drogouti M, Sofianou I, Michail A, Chatzis I, Donas G. Erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: a case report. J Pain Res. 2018 Sep 24;11:1983-1990. doi: 10.2147/JPR.S164489. eCollection 2018.
PubMed 30288093Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016Vyas KS, Rajendran S, Morrison SD, Shakir A, Mardini S, Lemaine V, Nahabedian MY, Baker SB, Rinker BD, Vasconez HC. Systematic Review of Liposomal Bupivacaine (Exparel) for Postoperative Analgesia. Plast Reconstr Surg. 2016 Oct;138(4):748e-756e. doi: 10.1097/PRS.0000000000002547.
PubMed 27673545Hadzic A, Minkowitz HS, Melson TI, Berkowitz R, Uskova A, Ringold F, Lookabaugh J, Ilfeld BM. Liposome Bupivacaine Femoral Nerve Block for Postsurgical Analgesia after Total Knee Arthroplasty. Anesthesiology. 2016 Jun;124(6):1372-83. doi: 10.1097/ALN.0000000000001117.
PubMed 27035853Wu ZQ, Min JK, Wang D, Yuan YJ, Li H. Liposome bupivacaine for pain control after total knee arthroplasty: a meta-analysis. J Orthop Surg Res. 2016 Jul 22;11(1):84. doi: 10.1186/s13018-016-0420-z.
PubMed 27443874Warner M, Yeap YL, Rigueiro G, Zhang P, Kasper K. Erector spinae plane block versus transversus abdominis plane block in laparoscopic hysterectomy. Pain Manag. 2022 Nov;12(8):907-916. doi: 10.2217/pmt-2022-0037. Epub 2022 Oct 10.
PubMed 36214314
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block Versus Transverse Abdominis Plane Block in Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT04003987
- Acronym / sponsor ID
- 1903977303
- Conditions
- Hysterectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 4 Mar 2021 (actual)
- Study completion
- 4 Mar 2021 (actual)
- First posted
- 1 Jul 2019 (actual)
- Results
- Posted 5 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 1. ESP Block Group 2. TAP Block Group
| Arm | Type | Receives |
|---|---|---|
| ESP Block | Active comparator | Drug: Liposomal bupivacaine, Drug: bupivacaine, 0.125%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) |
| TAP Block | Active comparator | Drug: Liposomal bupivacaine, Drug: bupivacaine, 0.125%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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal bupivacaineAlso: Exparel20ml | Drug | ESP Block, TAP Block |
| bupivacaine, 0.125%Also: bupivacaine60ml | Drug | ESP Block, TAP Block |
Primary outcome
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)
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)
8 secondary outcomes
Patient Sedation Score at 1 Hour
Time frame: 1 hour after surgery
Patient Sedation Score at 24 Hours
Time frame: 24 hours after surgery
Patient Sedation Score at 48 Hours
Time frame: 48 hours after surgery
Patient Nausea Score at 1 Hour
Time frame: 1 hour after surgery
Patient Nausea Score at 24 Hour
Time frame: 24 hour after surgery
Patient Nausea Score at 48 Hour
Time frame: 48 hour after surgery
Patient Satisfaction Score at 24 Hours
Time frame: 24 hours after surgery
Patient Satisfaction Score at 48 Hours
Time frame: 48 hours after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27830448Shaffer EE, Pham A, Woldman RL, Spiegelman A, Strassels SA, Wan GJ, Zimmerman T. Estimating the Effect of Intravenous Acetaminophen for Postoperative Pain Management on Length of Stay and Inpatient Hospital Costs. Adv Ther. 2017 Jan;33(12):2211-2228. doi: 10.1007/s12325-016-0438-y. Epub 2016 Nov 9.
- Results publication: PubMed 27856266Routman HD, Israel LR, Moor MA, Boltuch AD. Local injection of liposomal bupivacaine combined with intravenous dexamethasone reduces postoperative pain and hospital stay after shoulder arthroplasty. J Shoulder Elbow Surg. 2017 Apr;26(4):641-647. doi: 10.1016/j.jse.2016.09.033. Epub 2016 Nov 15.
- Results publication: PubMed 29723644Bacal V, Rana U, McIsaac DI, Chen I. Transversus Abdominis Plane Block for Post Hysterectomy Pain: A Systematic Review and Meta-Analysis. J Minim Invasive Gynecol. 2019 Jan;26(1):40-52. doi: 10.1016/j.jmig.2018.04.020. Epub 2018 Apr 30.
- Results publication: PubMed 30292068Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.
- Results publication: PubMed 30288093Petsas D, Pogiatzi V, Galatidis T, Drogouti M, Sofianou I, Michail A, Chatzis I, Donas G. Erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: a case report. J Pain Res. 2018 Sep 24;11:1983-1990. doi: 10.2147/JPR.S164489. eCollection 2018.
- Results publication: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Results publication: PubMed 27673545Vyas KS, Rajendran S, Morrison SD, Shakir A, Mardini S, Lemaine V, Nahabedian MY, Baker SB, Rinker BD, Vasconez HC. Systematic Review of Liposomal Bupivacaine (Exparel) for Postoperative Analgesia. Plast Reconstr Surg. 2016 Oct;138(4):748e-756e. doi: 10.1097/PRS.0000000000002547.
- Results publication: PubMed 27035853Hadzic A, Minkowitz HS, Melson TI, Berkowitz R, Uskova A, Ringold F, Lookabaugh J, Ilfeld BM. Liposome Bupivacaine Femoral Nerve Block for Postsurgical Analgesia after Total Knee Arthroplasty. Anesthesiology. 2016 Jun;124(6):1372-83. doi: 10.1097/ALN.0000000000001117.
- Results publication: PubMed 27443874Wu ZQ, Min JK, Wang D, Yuan YJ, Li H. Liposome bupivacaine for pain control after total knee arthroplasty: a meta-analysis. J Orthop Surg Res. 2016 Jul 22;11(1):84. doi: 10.1186/s13018-016-0420-z.
- Derived from this study: PubMed 36214314Warner M, Yeap YL, Rigueiro G, Zhang P, Kasper K. Erector spinae plane block versus transversus abdominis plane block in laparoscopic hysterectomy. Pain Manag. 2022 Nov;12(8):907-916. doi: 10.2217/pmt-2022-0037. Epub 2022 Oct 10.
- Individual participant dataSharing planned: No
Related trials for Hysterectomy
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Not yet recruiting
COMPARISON OF THE POSTOPERATIVE ANALGESIC EFFECTS OF ULTRASOUND-GUIDED QUADRO-ILIAC PLANE AND TRANSVERSUS ABDOMINIS PLANE BLOCKS IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY
Postoperative Pain Following Total Laparoscopic Hysterectomy
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
Active, not recruiting
Clinical Assessment - HominisTM Surgical System
Hysterectomy
RecruitingPhase 4
Preoperative Acetazolamide
Post Operative Pain, Laparoscopic Hysterectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yar Yeap, MD principal investigator
Indiana University Hospital
Matthew Warner, MD principal investigator
Indiana University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Liposomal bupivacaine and bupivacaine, 0.125% in people with Hysterectomy, run by Indiana University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) Pain Scores at Rest at 1 Hour. (time frame: 1 hour after surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04003987, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022; AzTrials last refreshed its copy on 30 Oct 2026.