Laparoscopic MyomectomyPhase 1NCT03935815
Quadratus Lumborum Nerve Blocks for Myomectomies
A Phase 1 study testing Ropivacaine injection in people with Laparoscopic Myomectomy and Quadratus Lumborum Nerve Block, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study would like to compare the use of the current standard of care in pain management for patients undergoing laparoscopic myomectomies to the addition of a quadratus lumborum nerve block plus the standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Laparoscopic Myomectomy, Quadratus Lumborum Nerve Block
- What is being tested?
- Ropivacaine injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 8 Jun 2020
- Phase
- Phase 1
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status 1-2,
- Female,
- greater than or equal to 18 years of age,
- undergoing laparoscopic myomectomy surgery
Who cannot join
- History of chronic pain requiring preoperative opioids,
- congenital coagulopathy,
- anatomic abnormalities,
- localized soft tissue infection,
- use of anticoagulants,
- unable to comprehend pain scoring system,
- severely obese (BMI > 35)
Trial locations and contacts
1 site in 1 country.
United States1 site
Ronald Reagan UCLA Medical Center, Department of Anesthesiology
Los Angeles, California, 90095
About this study
Official title: Quadratus Lumborum Nerve Blocks in Laparoscopic Myomectomy Patients
This study would like to compare the use of the current standard of care in pain management for patients undergoing laparoscopic myomectomies to the addition of a quadratus lumborum nerve block plus the standard of care. Patients will be consented and the nerve blocks will be placed after the patients are placed under general anesthesia. Standard pain management will continue regardless of which arm of the study patients are in and measurements of pain scores, narcotic usage and abdominal numbness will be assessed in the post-operative period.
Read the detailed description
This study aims to investigate benefits to the use of quadratus lumborum nerve blocks for laparoscopic myomectomies. Outcomes measured will be analgesic efficacy, incidence of post-operative events, patient satisfaction and narcotic usage.
Once a patient meets eligibility criteria and has consented to enter the study, randomization will be performed by the concealed envelope method. If chosen to be in the intervention group, a regional-trained anesthesiologist will perform the procedure, different from the intra-operative anesthesiologist. The control group will receive a superficial needle stick in the same location the quadratus lumborum block would have been otherwise placed.
Pre-operative protocol:
No premedications will be given while in the pre-operative waiting area. A member of the study group will randomly chose a concealed envelope indicating whether the patient will be in the control or intervention group.
Intraoperative protocol:
All patients will have standard ASA monitoring including: continuous electrocardiography, non-invasive blood pressure, percutaneous oxygen saturation, end-tidal carbon dioxide measurements, and heart rate.
Induction of general anesthesia and endotracheal intubation will be performed with propofol 1-2mg/kg and fentanyl 100 mcg. Dexamethasone 10mg IV will be administered for all patients for post-operative nausea risk reduction.
Maintenance of general anesthesia with be performed with sevoflurane 2-3% inhalation. Rocuronium 0.8-1 mg/kg intravenously will be administered for muscle relaxation.
After the patient is intubated and hemodynamically stable, the quadratus lumborum block procedure will be performed under ultrasound guidance by the regional trained anesthesiologist. First, a pillow or rolled blanket will be placed under the patient's hip for a semi-lateral position. 30 mL of 0.25% ropivacaine will be administered on both the right and left sides with a 20 gauge, 4 inch ultrasound needle using a SonoSite ultrasound machine with a linear transducer probe. The tip of the ultrasound needle will be placed posterior to the quadratus lumborum muscle (QL2) made in the plane between the quadratus lumborum muscle and thoracolumbar fascia.
After performing the block, intra-operative fentanyl administration will be at the discretion of the intraoperative anesthesiologist. On surgical closure, acetaminophen 1000 mg IV and ketorolac 15mg IV will be administered. No long acting opioids (eg hydromorphone, morphine) will be given intra-operatively. Ondansetron 4mg IV will be administered for post-operative nausea risk reduction. Sugammadex 2 mg/kg will be administered for reversal of neuromuscular blockade. Extubation will be performed by the intra-operative anesthesiologist.
Post-operative Protocol:
Patients will be asked their pain scores at rest and with movement at the designated time intervals: Arrival to PACU (t=0), 1 hr, 2hr, 3hr, and at PACU discharge. Severity of pain will be on a 10-point Numeric Rating Scale (NRS 0 = no pain, NRS 10 = worst imaginable pain).
A worksheet will be given to the patient at discharge and the patient will fill out her pain score 6 hours, 24 hours, and 48 hours after surgery. Nursing staff will ask and record pain scores while in the PACU in the electronic medical system. A study member will make phone calls home after PACU discharge to collect data from the patient.
While in the PACU, all patients will be ordered for intravenous fentanyl 25 mcg for mild pain, fentanyl 50 mcg for moderate pain, fentanyl 100 mcg for severe pain.
Patients will be ordered for oxycodone PO 5mg for mild pain, oxycodone PO 10mg for moderate pain, oxycodone PO 15 mg for severe pain while in the recovery room.
All patients will be discharged home with the same prescription of oxycodone 5mg, one pill every 4 hours as needed. All patients will be instructed to take acetaminophen 650mg every 6 hours by mouth for the first 24 hours (6 doses, total 2,600 mg for 24 hours) as needed.
It is currently not the standard of care to place these regional anesthesia nerve blocks, but we do think they offer great value and are hoping to produce results which will change what the standard of care entails.
- Being tested
- Ropivacaine injection, Sham treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine injectionDrug
30 mL of 0.25% ropivacaine will be administered on both the right and left sides with a 20 gauge, 4 inch ultrasound needle using a SonoSite ultrasound machine with a linear transducer probe. The tip of the ultrasound needle will be placed posterior to the quadratus lumborum muscle (QL2) made in the plane between the quadratus lumborum muscle and thoracolumbar fascia.
Sham treatmentProcedure or surgery
A sham procedure with a superficial 22 gauge needle stick will be performed without injectate.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Standard of care pain management plus quadratus lumborum nerve block.
Ropivicaine 0.25% 60 mL will be injected in the fascial plane between the quadratus lumborum muscle and transverses abdominus muscle. Receives: Drug: Ropivacaine injection |
| Control | Sham comparator | Standard of care pain management plus a sham procedure. Receives: Procedure: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine equivalents (MOE) consumption
The patient's cumulative intake of morphine over 24 hours.
Measured: Up to 24 hours after surgery
Secondary outcomes (1)
Pain Score
Rate of pain on a scale of 0-10 (0 is no pain and 10 is the worst pain possible)
Measured: Up to 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 posted2 May 2019
- Study start1 May 2019
- Primary completion6 Jun 2020
- Study completion8 Jun 2020
Why it stopped: Closed prior to completion secondary to surgeon leaving UCLA
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic MyomectomyStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natale Naim, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935815
- Sponsor's protocol ID
- 18-000825
- Status last verified
- Apr 2021
- First submitted
- 26 Feb 2019
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
PubMed 26225500Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.
PubMed 24249997Carvalho R, Segura E, Loureiro MD, Assuncao JP. [Quadratus lumborum block in chronic pain after abdominal hernia repair: case report]. Rev Bras Anestesiol. 2017 Jan-Feb;67(1):107-109. doi: 10.1016/j.bjan.2014.08.001. Epub 2014 Dec 6. Portuguese.
PubMed 25487690Visoiu M, Yakovleva N. Continuous postoperative analgesia via quadratus lumborum block - an alternative to transversus abdominis plane block. Paediatr Anaesth. 2013 Oct;23(10):959-61. doi: 10.1111/pan.12240. Epub 2013 Aug 9.
PubMed 23927552Chakraborty A, Goswami J, Patro V. Ultrasound-guided continuous quadratus lumborum block for postoperative analgesia in a pediatric patient. A A Case Rep. 2015 Feb 1;4(3):34-6. doi: 10.1213/XAA.0000000000000090.
PubMed 25642956
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadratus Lumborum Nerve Blocks in Laparoscopic Myomectomy Patients
- ClinicalTrials.gov ID
- NCT03935815
- Acronym / sponsor ID
- 18-000825
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed prior to completion secondary to surgeon leaving UCLA
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 6 Jun 2020 (actual)
- Study completion
- 8 Jun 2020 (actual)
- First posted
- 2 May 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.
This study would like to compare the use of the current standard of care in pain management for patients undergoing laparoscopic myomectomies to the addition of a quadratus lumborum nerve block plus the standard of care. Patients will be consented and the nerve blocks will be placed after the patients are placed under general anesthesia. Standard pain management will continue regardless of which arm of the study patients are in and measurements of pain scores, narcotic usage and abdominal numbness will be assessed in the post-operative period.
Detailed description
This study aims to investigate benefits to the use of quadratus lumborum nerve blocks for laparoscopic myomectomies. Outcomes measured will be analgesic efficacy, incidence of post-operative events, patient satisfaction and narcotic usage.
Once a patient meets eligibility criteria and has consented to enter the study, randomization will be performed by the concealed envelope method. If chosen to be in the intervention group, a regional-trained anesthesiologist will perform the procedure, different from the intra-operative anesthesiologist. The control group will receive a superficial needle stick in the same location the quadratus lumborum block would have been otherwise placed.
Pre-operative protocol:
No premedications will be given while in the pre-operative waiting area. A member of the study group will randomly chose a concealed envelope indicating whether the patient will be in the control or intervention group.
Intraoperative protocol:
All patients will have standard ASA monitoring including: continuous electrocardiography, non-invasive blood pressure, percutaneous oxygen saturation, end-tidal carbon dioxide measurements, and heart rate.
Induction of general anesthesia and endotracheal intubation will be performed with propofol 1-2mg/kg and fentanyl 100 mcg. Dexamethasone 10mg IV will be administered for all patients for post-operative nausea risk reduction.
Maintenance of general anesthesia with be performed with sevoflurane 2-3% inhalation. Rocuronium 0.8-1 mg/kg intravenously will be administered for muscle relaxation.
After the patient is intubated and hemodynamically stable, the quadratus lumborum block procedure will be performed under ultrasound guidance by the regional trained anesthesiologist. First, a pillow or rolled blanket will be placed under the patient's hip for a semi-lateral position. 30 mL of 0.25% ropivacaine will be administered on both the right and left sides with a 20 gauge, 4 inch ultrasound needle using a SonoSite ultrasound machine with a linear transducer probe. The tip of the ultrasound needle will be placed posterior to the quadratus lumborum muscle (QL2) made in the plane between the quadratus lumborum muscle and thoracolumbar fascia.
After performing the block, intra-operative fentanyl administration will be at the discretion of the intraoperative anesthesiologist. On surgical closure, acetaminophen 1000 mg IV and ketorolac 15mg IV will be administered. No long acting opioids (eg hydromorphone, morphine) will be given intra-operatively. Ondansetron 4mg IV will be administered for post-operative nausea risk reduction. Sugammadex 2 mg/kg will be administered for reversal of neuromuscular blockade. Extubation will be performed by the intra-operative anesthesiologist.
Post-operative Protocol:
Patients will be asked their pain scores at rest and with movement at the designated time intervals: Arrival to PACU (t=0), 1 hr, 2hr, 3hr, and at PACU discharge. Severity of pain will be on a 10-point Numeric Rating Scale (NRS 0 = no pain, NRS 10 = worst imaginable pain).
A worksheet will be given to the patient at discharge and the patient will fill out her pain score 6 hours, 24 hours, and 48 hours after surgery. Nursing staff will ask and record pain scores while in the PACU in the electronic medical system. A study member will make phone calls home after PACU discharge to collect data from the patient.
While in the PACU, all patients will be ordered for intravenous fentanyl 25 mcg for mild pain, fentanyl 50 mcg for moderate pain, fentanyl 100 mcg for severe pain.
Patients will be ordered for oxycodone PO 5mg for mild pain, oxycodone PO 10mg for moderate pain, oxycodone PO 15 mg for severe pain while in the recovery room.
All patients will be discharged home with the same prescription of oxycodone 5mg, one pill every 4 hours as needed. All patients will be instructed to take acetaminophen 650mg every 6 hours by mouth for the first 24 hours (6 doses, total 2,600 mg for 24 hours) as needed.
It is currently not the standard of care to place these regional anesthesia nerve blocks, but we do think they offer great value and are hoping to produce results which will change what the standard of care entails.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Drug: Ropivacaine injectionStandard of care pain management plus quadratus lumborum nerve block. Ropivicaine 0.25% 60 mL will be injected in the fascial plane between the quadratus lumborum muscle and transverses abdominus muscle. |
| Control | Sham comparator | Procedure: Sham treatmentStandard of care pain management plus a sham procedure. |
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)
- American Society of Anesthesiologists (ASA) physical status 1-2,
- Female,
- greater than or equal to 18 years of age,
- undergoing laparoscopic myomectomy surgery
Key exclusion criteria (7 listed)
- History of chronic pain requiring preoperative opioids,
- congenital coagulopathy,
- anatomic abnormalities,
- localized soft tissue infection,
- use of anticoagulants,
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 |
|---|---|---|
| Ropivacaine injection30 mL of 0.25% ropivacaine will be administered on both the right and left sides with a 20 gauge, 4 inch ultrasound needle using a SonoSite ultrasound machine with a linear transducer probe. The tip of the ultrasound needle will be placed posterior to the quadratus lumborum muscle (QL2) made in the plane between the quadratus lumborum muscle and thoracolumbar fascia. | Drug | Intervention |
| Sham treatmentA sham procedure with a superficial 22 gauge needle stick will be performed without injectate. | Procedure or surgery | Control |
Primary outcome
Morphine equivalents (MOE) consumption
Time frame: Up to 24 hours after surgery
The patient's cumulative intake of morphine over 24 hours.
1 secondary outcome
Pain Score
Time frame: Up to 48 hours after surgery
Results and safety
The study was stopped early (reason given: Closed prior to completion secondary to surgeon leaving UCLA). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Results publication: PubMed 26225500Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
- Results publication: PubMed 24249997Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.
- Results publication: PubMed 25487690Carvalho R, Segura E, Loureiro MD, Assuncao JP. [Quadratus lumborum block in chronic pain after abdominal hernia repair: case report]. Rev Bras Anestesiol. 2017 Jan-Feb;67(1):107-109. doi: 10.1016/j.bjan.2014.08.001. Epub 2014 Dec 6. Portuguese.
- Results publication: PubMed 23927552Visoiu M, Yakovleva N. Continuous postoperative analgesia via quadratus lumborum block - an alternative to transversus abdominis plane block. Paediatr Anaesth. 2013 Oct;23(10):959-61. doi: 10.1111/pan.12240. Epub 2013 Aug 9.
- Results publication: PubMed 25642956Chakraborty A, Goswami J, Patro V. Ultrasound-guided continuous quadratus lumborum block for postoperative analgesia in a pediatric patient. A A Case Rep. 2015 Feb 1;4(3):34-6. doi: 10.1213/XAA.0000000000000090.
Related trials for Laparoscopic Myomectomy
Not yet recruiting
LapBox® Manual Containment System
Surgery
RecruitingPhase 4
QL Block in Laparoscopic Myomectomy
Postoperative Pain, Fibroid Uterus
Recruiting
Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy
Myoma
RecruitingObservational study
Outpatient Visits Versus Telehealth for Postoperative Care After Minimally Invasive Gynecologic Surgery
to Determine Whether Patient Satisfaction With Postoperative Telehealth Follow-up is Non-inferior to In-person Clinic Visits
Recruiting
Temporary Uterine Tourniquet Application Versus Local Myometrial Epinephrine Injection During Laparoscopic Myomectomy
Laparoscopic Myomectomy
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ropivacaine injection in people with Laparoscopic Myomectomy and Quadratus Lumborum Nerve Block, run by University of California, Los Angeles 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 4 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 28 Apr 2021. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Closed prior to completion secondary to surgeon leaving UCLA). 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?
Morphine equivalents (MOE) consumption (time frame: Up to 24 hours after surgery). 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 NCT03935815, which also lists 5 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 28 Apr 2021.