Postoperative PainNCT04074226
ESP vs QL for Total Abdominal Hysterectomy
A study testing Erector Spinae Plane block and Quadratus Lumborum Block in people with Postoperative Pain, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Patients undergoing open total abdominal hysterectomy (n=82) at Parkland Memorial Hospital will be randomized into one of two groups to receive either ultrasound-guided bilateral ESP block with liposomal bupivacaine (Group 1) or ultrasound-guided bilateral QL block with liposomal bupivacaine (Group 2) for… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Erector Spinae Plane block and Quadratus Lumborum Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2021to 21 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female ASA physical status 1-3 scheduled for open abdominal hysterectomy
- Age 18-80 years old
- Able to participate personally or by legal representative in informed consent in English or Spanish
Who cannot join
- History of relevant drug allergy
- Age less than 18 or greater than 80 years
- Chronic opioid use or drug abuse
- Active use of anticoagulant medication
- Significant psychiatric disturbance
- Inability to understand the study protocol
- Refusal to provide written consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Parkland Health and Hospital System
Dallas, Texas, 75390
About this study
Official title: Erector Spinae Plane (ESP) Block With Liposomal Bupivacaine Versus Quadratus Lumborum (QL) Block With Liposomal Bupivacaine for Postoperative Pain Management After Open Total Abdominal Hysterectomy: A Prospective Randomized Controlled Trial
Patients undergoing open total abdominal hysterectomy (n=82) at Parkland Memorial Hospital will be randomized into one of two groups to receive either ultrasound-guided bilateral ESP block with liposomal bupivacaine (Group 1) or ultrasound-guided bilateral QL block with liposomal bupivacaine (Group 2) for postoperative pain management. The remaining aspect of perioperative care, including the general anesthetic technique and postoperative care will be standardized and will be similar for all patients. The duration of the involvement in the study will be until 72 hours postoperatively. Anesthesia providers will identify potential subjects during their Pre-Anesthesia Evaluation Clinic visit and/or Day Surgery Unit pre-anesthetic assessment. There will be no incentive or payment to the patients.
Patients in Group 1 will receive ultrasound-guided bilateral ESP block in the preoperative holding area prior to surgery. Patients in Group 2 will receive ultrasound-guided QL block in the preoperative holding area prior to surgery. All patients will have general anesthesia per previously established Parkland Enhanced Recovery After Surgery (ERAS) protocols. Postoperatively, patients in both Groups will receive acetaminophen 1000 mg orally every 8 hours, meloxicam 15 mg orally every 24 hours, and immediate-release oxycodone 5 - 10mg orally every 4 hours as needed for breakthrough pain.
The postoperative analgesia will be documented using the Numeric Rating Scale (0-10 scale where 0=no pain and 10=worst pain). In addition, total opioid dose over the 72-hours study period will be documented. Postoperative nausea will be measured using a categorical scoring system (none=0, mild=1, moderate=2, severe=3) and episodes of vomiting will be documented. Rescue anti-emetics will be given to any patient who complains of nausea and/or vomiting. All variables will be assessed at 4, 6, 12, 24, 48, and 72 hours, postoperatively by an investigator blinded to group allocation.
Read the detailed description
The investigators will study 82 American Society of Anesthesiologists (ASA) physical status 1-3 subjects scheduled for open Total Abdominal Hysterectomy who will be identified by anesthesia providers during their Pre-Anesthesia Evaluation Clinic visit and/or Day Surgery Unit pre-anesthetic assessment at Parkland Hospital. If the subjects agree to participate in the study, the researchers will determine eligibility. If the subject meets all inclusion/exclusion criteria, the subject will be asked to sign the Consent Form and HIPAA Authorization Form prior to any study procedures in a face-to-face meeting with the researchers.
Protected patient information will include name, medical record number, date of birth, and contact information including telephone number. Height and weight will also be recorded. All patients will receive a standardized general anesthetic based on Enhanced Recovery After Surgery protocols. One of the investigators will randomly allocate patients using computer generated randomization schedule to one of the two groups.
Study Groups:
Group 1: Ultrasound-guided ESP block with liposomal bupivacaine
Group 2: Ultrasound-guided QL block with liposomal bupivacaine.
Anesthesiologists with previous experience in ultrasound-guided regional anesthesia procedures will perform the block based on randomization results. In both groups the patient will be placed in a sitting position, a SonoSite X-Porte linear ultrasound transducer will be used for real-time ultrasound guidance.
Group 1: For the QL block, the transducer will be placed transversely over the lumbar spine at the level of the iliac crest. Then, the anesthesiologist will scan laterally to identify the ipsilateral L3 transverse process, psoas muscle, and quadratus lumborum muscle to identify the "Shamrock Sign" (7). Following aseptic preparation of the injection site and the ultrasound probe, a 22-gauge, 10mm block needle will be introduced parallel to the ultrasound guided beam (in-plane technique) until its tip reaches the plane between the quadratus lumborum muscle and psoas muscle. After negative aspiration, 20 ml of a mixture containing 10ml 0.25% bupivacaine and 10ml 1.3% liposomal bupivacaine will be injected in 5 ml increments to separate the fascial plane between the two muscles. The investigators will observe local anesthetic spread under real-time imaging. The block will then be performed in the same manner on the opposite site.
Group 2: For the ESP block, the transducer will be placed parasagittally at the level of the tip of the scapula and the anesthesiologist will scan in a craniocaudal manner to identify the ipsilateral T10 transverse process and overlying erector spinae muscle. Following aseptic preparation of the injection site and the ultrasound probe, a 22-gauge, 10mm block needle will be introduced parallel to the ultrasound guided beam (in-plane technique) until its tip reaches the plane between the erector spinae muscle and transverse process. After negative aspiration, 20 ml of a mixture containing 10ml 0.25% bupivacaine and 10ml 1.3% liposomal bupivacaine will be injected in 5 ml increments to separate the fascial plane between the muscle and transverse process. The investigators will observe local anesthetic spread under real-time imaging. The block will then be performed in the same manner on the opposite site.
A standard postoperative analgesic regimen in both groups will include acetaminophen 1000 mg, orally every 8 hours and meloxicam 15mg, orally every 24 hours. For breakthrough pain (or rescue), immediate-release oxycodone 5-10mg, orally every 4 hours as needed for pain will be provided.
The efficacy of postoperative analgesia will be documented in all patients using the visual analog score (0=no pain, 10=worst pain). In addition, total morphine dose over the 72-hours study period will be documented. Postoperative nausea will be measured using a categorical scoring system (none=0, mild=1, moderate=2, severe=3) and episodes of vomiting will be documented. Rescue antiemetics will be given to any patient who complains of nausea or vomiting. All variables will be assessed at 4, 6, 12, 24, 48, and 72 hours postoperatively by an investigator blinded to group allocation.
For each patient the following data will be recorded:
Preoperatively:
- Age
- Gender
- Height
- Weight
- Baseline pain score
- Pre-operative block procedure, duration, amount of analgesia used
- Time to perform the blocks
Intraoperatively:
- Surgical time
Postoperatively:
- Post-Anesthesia Care Unit time
- Post-operative pain scores at 4, 6, 12, 24, 48, 72 hours
- cumulative opioid consumption during the first 24-hours postoperatively
- Time to first ambulation
- Time to first oral intake
- Time to be ready for discharge home
- Conditions
- Postoperative Pain
- Being tested
- Erector Spinae Plane block, Quadratus Lumborum Block
- Keywords
- regional anesthesia, postoperative pain, erector spinae plane block, quadratus lumborum block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane blockProcedure or surgery
The Erector Spinae Plane (ESP) block is a new block first described in 2016 which blocks terminal branches of the lower thoracic and lumbar nerve roots. It is performed by injection of local anesthetic in the fascial plane below the erector spinae muscle group.
Quadratus Lumborum BlockProcedure or surgery
Ultrasound-guided QL block has been reported to provide effective analgesia in patients undergoing lower abdominal surgical procedures, including in patients undergoing abdominal hysterectomy. Ultrasound guidance offers a number of advantages, including the ability to visualize the anatomy, perform real-time navigation, and direct observation of local anesthetic spread. The QL block is performed via ultrasound-guided injection of local anesthetic in the fascial planes above or below the QL muscle
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided ESP block with liposomal bupivacaine | Experimental | For the ESP block, the transducer will be placed parasagittally at the level of the tip of the scapula and the anesthesiologist will scan in a craniocaudal manner to identify the ipsilateral T10 transverse process and overlying erector spinae muscle. Following aseptic preparation of the injection site and the ultrasound probe, a 22-gauge, 10mm block needle will be introduced parallel to the ultrasound guided beam (in-plane technique) until its tip reaches the plane between the erector spinae muscle and transverse process. After negative aspiration, 20 ml of a mixture containing 10ml 0.25% bupivacaine and 10ml 1.3% liposomal bupivacaine will be injected in 5 ml increments to separate the fascial plane between the muscle and transverse process. The investigators will observe local anesthetic spread under real-time imaging. The block will then be performed in the same manner on the opposite site. Receives: Procedure: Erector Spinae Plane block |
| Ultrasound-guided QL block with liposomal bupivacaine | Active comparator | For the QL block, the transducer will be placed transversely over the lumbar spine at the level of the iliac crest. Then, the anesthesiologist will scan laterally to identify the ipsilateral L3 transverse process, psoas muscle, and quadratus lumborum muscle to identify the "Shamrock Sign" (7). Following aseptic preparation of the injection site and the ultrasound probe, a 22-gauge, 10mm block needle will be introduced parallel to the ultrasound guided beam (in-plane technique) until its tip reaches the plane between the quadratus lumborum muscle and psoas muscle. After negative aspiration, 20 ml of a mixture containing 10ml 0.25% bupivacaine and 10ml 1.3% liposomal bupivacaine will be injected in 5 ml increments to separate the fascial plane between the two muscles. The investigators will observe local anesthetic spread under real-time imaging. The block will then be performed in the same manner on the opposite site. Receives: Procedure: Quadratus Lumborum Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain (NRS = numeric rating scale) at 24 hours
The primary aim of this study is to compare postoperative pain scores at 24 hours between the subjects who receive ESP block with liposomal bupivacaine and the subjects who receive QL block with liposomal bupivacaine undergoing Total Abdominal Hysterectomy. The investigators will use the Numeric Rating Scale, measuring patient report of pain from 0 = no pain up to 10 = worst possible pain.
Measured: 24 hours
Secondary outcomes (7)
Postoperative Pain (NRS = numeric rating scale) at 48 hours
One secondary objectives is to compare pain scores at 48 hours. The investigators will use the Numeric Rating Scale, measuring patient report of pain from 0 = no pain up to 10 = worst possible pain.
Measured: 48 hours
Postoperative Pain (NRS = numeric rating scale) at 72 hours
Another secondary objective is to compare pain scores at 48 hours and 72 hours. The investigators will use the Numeric Rating Scale, measuring patient report of pain from 0 = no pain up to 10 = worst possible pain.
Measured: 72 hours
Opioid Use (oral morphine equivalents)
Another secondary objective is to assess cumulative opioid consumption during the first 24-hours postoperatively. The investigators will convert all opioids consumed in this time from to oral morphine equivalents.
Measured: 24 hours
Block Time (minutes)
Antoher secondary objective is to assess the time to perform the blocks as measured in minutes.
Measured: 1 hour
Ambulation Time (hours:minutes)
Another secondary objective is to assess the time to first ambulation as measured in hours:minutes after the end of surgery.
Measured: 24 hours
Oral Intake Time (hours:minutes)
Another secondary objective is to assess the time to first oral intake as measured in hours:minutes after the end of surgery.
Measured: 24 hours
Discharge Readiness Time (hours:minutes)
Another secondary objective is to assess the time time for discharge readiness as measured in hours:minutes after the end of surgery.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start20 Mar 2021
- Primary completion20 Mar 2023
- Study completion21 Mar 2023
Why it stopped: Inability to recruit patients for the past several months due to all the staffing shortages and changes to the surgeons' practice patterns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Alexander, University of Texas Southwestern Medical Center
- Investigators
- John C Alexander, MD, Principal investigator, UT Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074226
- Sponsor's protocol ID
- STU-2019-1174
- Status last verified
- Mar 2023
- First submitted
- 26 Jul 2019
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be shared
Publications
Elsharkawy H, Bajracharya GR, El-Boghdadly K, Drake RL, Mariano ER. Comparing two posterior quadratus lumborum block approaches with low thoracic erector spinae plane block: an anatomic study. Reg Anesth Pain Med. 2019 Mar 28:rapm-2018-100147. doi: 10.1136/rapm-2018-100147. Online ahead of print.
PubMed 30923253Elsharkawy H, El-Boghdadly K, Barrington M. Quadratus Lumborum Block: Anatomical Concepts, Mechanisms, and Techniques. Anesthesiology. 2019 Feb;130(2):322-335. doi: 10.1097/ALN.0000000000002524. No abstract available.
PubMed 30688787Forero 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 27501016
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane (ESP) Block With Liposomal Bupivacaine Versus Quadratus Lumborum (QL) Block With Liposomal Bupivacaine for Postoperative Pain Management After Open Total Abdominal Hysterectomy: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04074226
- Acronym / sponsor ID
- STU-2019-1174
- Conditions
- Postoperative Pain
- Keywords
- regional anesthesia, postoperative pain, erector spinae plane block, quadratus lumborum block
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to recruit patients for the past several months due to all the staffing shortages and changes to the surgeons' practice patterns
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 20 Mar 2021 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 30 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients undergoing open total abdominal hysterectomy (n=82) at Parkland Memorial Hospital will be randomized into one of two groups to receive either ultrasound-guided bilateral ESP block with liposomal bupivacaine (Group 1) or ultrasound-guided bilateral QL block with liposomal bupivacaine (Group 2) for postoperative pain management. The remaining aspect of perioperative care, including the general anesthetic technique and postoperative care will be standardized and will be similar for all patients. The duration of the involvement in the study will be until 72 hours postoperatively. Anesthesia providers will identify potential subjects during their Pre-Anesthesia Evaluation Clinic visit and/or Day Surgery Unit pre-anesthetic assessment. There will be no incentive or payment to the patients.
Patients in Group 1 will receive ultrasound-guided bilateral ESP block in the preoperative holding area prior to surgery. Patients in Group 2 will receive ultrasound-guided QL block in the preoperative holding area prior to surgery. All patients will have general anesthesia per previously established Parkland Enhanced Recovery After Surgery (ERAS) protocols. Postoperatively, patients in both Groups will receive acetaminophen 1000 mg orally every 8 hours, meloxicam 15 mg orally every 24 hours, and immediate-release oxycodone 5 - 10mg orally every 4 hours as needed for breakthrough pain.
The postoperative analgesia will be documented using the Numeric Rating Scale (0-10 scale where 0=no pain and 10=worst pain). In addition, total opioid dose over the 72-hours study period will be documented. Postoperative nausea will be measured using a categorical scoring system (none=0, mild=1, moderate=2, severe=3) and episodes of vomiting will be documented. Rescue anti-emetics will be given to any patient who complains of nausea and/or vomiting. All variables will be assessed at 4, 6, 12, 24, 48, and 72 hours, postoperatively by an investigator blinded to group allocation.
Detailed description
The investigators will study 82 American Society of Anesthesiologists (ASA) physical status 1-3 subjects scheduled for open Total Abdominal Hysterectomy who will be identified by anesthesia providers during their Pre-Anesthesia Evaluation Clinic visit and/or Day Surgery Unit pre-anesthetic assessment at Parkland Hospital. If the subjects agree to participate in the study, the researchers will determine eligibility. If the subject meets all inclusion/exclusion criteria, the subject will be asked to sign the Consent Form and HIPAA Authorization Form prior to any study procedures in a face-to-face meeting with the researchers.
Protected patient information will include name, medical record number, date of birth, and contact information including telephone number. Height and weight will also be recorded. All patients will receive a standardized general anesthetic based on Enhanced Recovery After Surgery protocols. One of the investigators will randomly allocate patients using computer generated randomization schedule to one of the two groups.
Study Groups:
Group 1: Ultrasound-guided ESP block with liposomal bupivacaine
Group 2: Ultrasound-guided QL block with liposomal bupivacaine.
Anesthesiologists with previous experience in ultrasound-guided regional anesthesia procedures will perform the block based on randomization results. In both groups the patient will be placed in a sitting position, a SonoSite X-Porte linear ultrasound transducer will be used for real-time ultrasound guidance.
Group 1: For the QL block, the transducer will be placed transversely over the lumbar spine at the level of the iliac crest. Then, the anesthesiologist will scan laterally to identify the ipsilateral L3 transverse process, psoas muscle, and quadratus lumborum muscle to identify the "Shamrock Sign" (7). Following aseptic preparation of the injection site and the ultrasound probe, a 22-gauge, 10mm block needle will be introduced parallel to the ultrasound guided beam (in-plane technique) until its tip reaches the plane between the quadratus lumborum muscle and psoas muscle. After negative aspiration, 20 ml of a mixture containing 10ml 0.25% bupivacaine and 10ml 1.3% liposomal bupivacaine will be injected in 5 ml increments to separate the fascial plane between the two muscles. The investigators will observe local anesthetic spread under real-time imaging. The block will then be performed in the same manner on the opposite site.
Group 2: For the ESP block, the transducer will be placed parasagittally at the level of the tip of the scapula and the anesthesiologist will scan in a craniocaudal manner to identify the ipsilateral T10 transverse process and overlying erector spinae muscle. Following aseptic preparation of the injection site and the ultrasound probe, a 22-gauge, 10mm block needle will be introduced parallel to the ultrasound guided beam (in-plane technique) until its tip reaches the plane between the erector spinae muscle and transverse process. After negative aspiration, 20 ml of a mixture containing 10ml 0.25% bupivacaine and 10ml 1.3% liposomal bupivacaine will be injected in 5 ml increments to separate the fascial plane between the muscle and transverse process. The investigators will observe local anesthetic spread under real-time imaging. The block will then be performed in the same manner on the opposite site.
A standard postoperative analgesic regimen in both groups will include acetaminophen 1000 mg, orally every 8 hours and meloxicam 15mg, orally every 24 hours. For breakthrough pain (or rescue), immediate-release oxycodone 5-10mg, orally every 4 hours as needed for pain will be provided.
The efficacy of postoperative analgesia will be documented in all patients using the visual analog score (0=no pain, 10=worst pain). In addition, total morphine dose over the 72-hours study period will be documented. Postoperative nausea will be measured using a categorical scoring system (none=0, mild=1, moderate=2, severe=3) and episodes of vomiting will be documented. Rescue antiemetics will be given to any patient who complains of nausea or vomiting. All variables will be assessed at 4, 6, 12, 24, 48, and 72 hours postoperatively by an investigator blinded to group allocation.
For each patient the following data will be recorded:
Preoperatively:
- Age
- Gender
- Height
- Weight
- Baseline pain score
- Pre-operative block procedure, duration, amount of analgesia used
- Time to perform the blocks
Intraoperatively:
- Surgical time
Postoperatively:
- Post-Anesthesia Care Unit time
- Post-operative pain scores at 4, 6, 12, 24, 48, 72 hours
- cumulative opioid consumption during the first 24-hours postoperatively
- Time to first ambulation
- Time to first oral intake
- Time to be ready for discharge home
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided ESP block with liposomal bupivacaine | Experimental | Procedure: Erector Spinae Plane blockFor the ESP block, the transducer will be placed parasagittally at the level of the tip of the scapula and the anesthesiologist will scan in a craniocaudal manner to identify the ipsilateral T10 transverse process and overlying erector spinae muscle. Following aseptic preparation of the injection site and the ultrasound probe, a 22-gauge, 10mm block needle will be introduced parallel to the ultrasound guided beam (in-plane technique) until its tip reaches the plane between the erector spinae muscle and transverse process. After negative aspiration, 20 ml of a mixture containing 10ml 0.25% bupivacaine and 10ml 1.3% liposomal bupivacaine will be injected in 5 ml increments to separate the fascial plane between the muscle and transverse process. The investigators will observe local anesthetic spread under real-time imaging. The block will then be performed in the same manner on the opposite site. |
| Ultrasound-guided QL block with liposomal bupivacaine | Active comparator | Procedure: Quadratus Lumborum BlockFor the QL block, the transducer will be placed transversely over the lumbar spine at the level of the iliac crest. Then, the anesthesiologist will scan laterally to identify the ipsilateral L3 transverse process, psoas muscle, and quadratus lumborum muscle to identify the "Shamrock Sign" (7). Following aseptic preparation of the injection site and the ultrasound probe, a 22-gauge, 10mm block needle will be introduced parallel to the ultrasound guided beam (in-plane technique) until its tip reaches the plane between the quadratus lumborum muscle and psoas muscle. After negative aspiration, 20 ml of a mixture containing 10ml 0.25% bupivacaine and 10ml 1.3% liposomal bupivacaine will be injected in 5 ml increments to separate the fascial plane between the two muscles. The investigators will observe local anesthetic spread under real-time imaging. The block will then be performed in the same manner on the opposite site. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female ASA physical status 1-3 scheduled for open abdominal hysterectomy
- Age 18-80 years old
- Able to participate personally or by legal representative in informed consent in English or Spanish
Key exclusion criteria (7 listed)
- History of relevant drug allergy
- Age less than 18 or greater than 80 years
- Chronic opioid use or drug abuse
- Active use of anticoagulant medication
- Significant psychiatric disturbance
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 |
|---|---|---|
| Erector Spinae Plane blockThe Erector Spinae Plane (ESP) block is a new block first described in 2016 which blocks terminal branches of the lower thoracic and lumbar nerve roots. It is performed by injection of local anesthetic in the fascial plane below the erector spinae muscle group. | Procedure or surgery | Ultrasound-guided ESP block with liposomal bupivacaine |
| Quadratus Lumborum BlockUltrasound-guided QL block has been reported to provide effective analgesia in patients undergoing lower abdominal surgical procedures, including in patients undergoing abdominal hysterectomy. Ultrasound guidance offers a number of advantages, including the ability to visualize the anatomy, perform real-time navigation, and direct observation of local anesthetic spread. The QL block is performed via ultrasound-guided injection of local anesthetic in the fascial planes above or below the QL muscle | Procedure or surgery | Ultrasound-guided QL block with liposomal bupivacaine |
Primary outcome
Postoperative pain (NRS = numeric rating scale) at 24 hours
Time frame: 24 hours
The primary aim of this study is to compare postoperative pain scores at 24 hours between the subjects who receive ESP block with liposomal bupivacaine and the subjects who receive QL block with liposomal bupivacaine undergoing Total Abdominal Hysterectomy. The investigators will use the Numeric Rating Scale, measuring patient report of pain from 0 = no pain up to 10 = worst possible pain.
7 secondary outcomes
Postoperative Pain (NRS = numeric rating scale) at 48 hours
Time frame: 48 hours
Postoperative Pain (NRS = numeric rating scale) at 72 hours
Time frame: 72 hours
Opioid Use (oral morphine equivalents)
Time frame: 24 hours
Block Time (minutes)
Time frame: 1 hour
Ambulation Time (hours:minutes)
Time frame: 24 hours
Oral Intake Time (hours:minutes)
Time frame: 24 hours
Discharge Readiness Time (hours:minutes)
Time frame: 72 hours
Results and safety
The study was stopped early (reason given: Inability to recruit patients for the past several months due to all the staffing shortages and changes to the surgeons' practice patterns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Background: PubMed 30923253Elsharkawy H, Bajracharya GR, El-Boghdadly K, Drake RL, Mariano ER. Comparing two posterior quadratus lumborum block approaches with low thoracic erector spinae plane block: an anatomic study. Reg Anesth Pain Med. 2019 Mar 28:rapm-2018-100147. doi: 10.1136/rapm-2018-100147. Online ahead of print.
- Background: PubMed 30688787Elsharkawy H, El-Boghdadly K, Barrington M. Quadratus Lumborum Block: Anatomical Concepts, Mechanisms, and Techniques. Anesthesiology. 2019 Feb;130(2):322-335. doi: 10.1097/ALN.0000000000002524. No abstract available.
- Background: 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.
- Individual participant dataSharing planned: No. Individual Participant Data will not be shared
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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.
John C Alexander, MD principal investigator
UT Southwestern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane block and Quadratus Lumborum Block in people with Postoperative Pain, run by University of Texas Southwestern Medical Center at 1 site 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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study was stopped early (reason given: Inability to recruit patients for the past several months due to all the staffing shortages and changes to the surgeons' practice patterns). Results are not available in the source record.
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?
Postoperative pain (NRS = numeric rating scale) at 24 hours (time frame: 24 hours). 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 NCT04074226, which also lists 3 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 4 Apr 2023.