Post-operative PainNCT04549090
Ultrasound Guided Posterior Quadratus Lumborum Block for Postoperative Analgesia in Gynecologic Surgery
An observational study of Post-operative Pain and Gynecologic Surgery, run by Pedram Bral at 1 site in United States.
Trial summary
The challenge to achieve adequate analgesia has led to the development of directed, multi-modal protocols specific to management of post-laparoscopy pain in effort to decrease the amount of additional administration of narcotic medication. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain, Gynecologic Surgery, Regional Anesthesia
- What is being tested?
- QL (quadratus lumborum) block administration
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 5 Apr 2022
- Phase
- Observational
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients between the ages of 18 to 65 scheduled to undergo laparoscopic or robotic total or supracervical hysterectomy for benign indications
Who may be able to join
- Patients will be eligible for recruitment if between the ages of 18 to 65 scheduled to undergo laparoscopic or robotic total or supracervical hysterectomy for benign indications. Only surgery for benign pathology will be considered to enrollment. No Malignancy cases will be included.
Who cannot join
- 1. History of adverse reaction or allergy to Bupivacaine or liposomal bupivacaine
- 2. Medical contraindication to placement of QL block.
- 3. Suspicion of possible reproductive cancer with contraindication of morcellation of uterine tissue.
- 4. Significant medical condition or laboratory result that in the opinion of the Investigator indicate an increased vulnerability to study subject which exposes the subject to an unreasonable risk as a result of participating.
- 5. Any clinically significant condition uncovered during the surgery, such as excessive bleeding or decompensation, that might render the subject medically unstable to continue the study or complicate the subject's intraoperative or postoperative course.
- 6. Pregnant patients
- 7. Less than 40Kg weight.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Posterior Quadratus Lumborum Block for Improved Postoperative Analgesia in Minimally Invasive Gynecologic Surgery
The challenge to achieve adequate analgesia has led to the development of directed, multi-modal protocols specific to management of post-laparoscopy pain in effort to decrease the amount of additional administration of narcotic medication. While several non-opioid regiments have been found to be effective, opioid medications still play a significant role in early postoperative analgesia. Given the adverse side effects of narcotic medications, regional blocks utilizing local anesthetic agents and has been shown to improve overall pain control in this time period.
Truncal abdominal nerve blocks are useful for pain control in abdominal and pelvic surgeries. More recently, the utilization of the quadratus lumborum (QL) block has effectively alleviated somatic and visceral pain in the upper and lower abdomen. The QL block provides analgesia spanning from the T4 to L1 dermatomal levels in the thoracolumbar plane to provide a broad sensory level analgesic effect. The approach involves injecting local anesthetic under ultrasound guidance into the plane posterior to the quadratus lumborum muscle and middle layer of thoracolumbar fascia.
Given the utility of the QL block in controlling somatic pain, this study aims to determine whether the QL block is an effective analgesic adjunct in the control of postoperative pain period, specifically with regards to patients undergoing laparoscopic gynecologic surgery.
Read the detailed description
Prospective Cohort observational study. All patients that meet criteria for participation in this study will be screened: patients scheduled to undergo a laparoscopic hysterectomy for benign conditions by attending physicians in the division of Minimally Invasive Gynecologic Surgery. Based on surgeon's preference, and patient's consent, the patient is offered a QL block or not. Our aim is to follow the patient's pain scores post op and amount of oral pain medication used whether they received QL block or not. If the patient received the QL block then they will be considered part of the study arm. If the patient did not receive the QL block then they will be considered part of the control arm.
The QL block is best thought of as a volume or compartment block in that volumetric spread of LA along the fascial plane is associated with efficacy in blocking the thoracolumbar nerves between T7-L1. It can be reasonably assumed that this compartment is the same across patients and is not affected by the amount of subcutaneous or central fat present in the obese patient.
If a block is to be performed, the QL block will be performed using a 21G x 100mm Stimuplex needle under ultrasound guidance using a curvilinear probe. Subjects will be positioned in the semi-lateral position to facilitate access into the plane posterior to the quadratus lumborum muscle and middle layer of thoracolumbar fascia. The QL block will be administered via an in-plane approach and local anesthetic will be injected between the quadratus lumborum muscle and the middle layer of the thoracolumbar. The QL block will be in the operating room after induction prior to starting the scheduled surgical procedure. If the block is performed, it will include 20ml of 0.25% bupivacaine and 5ml of liposomal bupivacaine (Exparel) per side. The block will be done bilaterally therefore a total of 40ml of 0.25% bupivacaine and 10ml of liposomal bupivacaine (Exparel) will be administered.
- Being tested
- QL (quadratus lumborum) block administration
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL (quadratus lumborum) block administrationDrug
Fo the QL block group, they will be receiving bilateral QL block. A total of 40ml of 0.25% bupivacaine (Marcaine) and 10ml of liposomal bupivacaine (Exparel) will be administered
| Study group | Role | What they receive |
|---|---|---|
| No QL block group | These patients will not be receiving QL block based on their shared decision with their surgeon and anesthesiologist. Patients' pain scores and amount of pain killers will be followed up for 24 hours postoperatively | |
| QL block group | These patients will be receiving QL block based on their shared decision with their surgeon and anesthesiologist. Patients' pain scores and amount of pain killers will be followed up for 24 hours postoperatively Receives: Drug: QL (quadratus lumborum) block administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in pain score
Our primary outcome is difference in pain scores at 3 hours between the two groups. The pain score will be assessed using Numeric Rating Scale (NRS) from 0-10 with 0 as no pain and 10 as worst possible pain
Measured: 3 hours postoperative
Secondary outcomes (3)
Difference in pain score
Our secondary outcome is difference in pain scores at 1 hour between the two groups. The pain score will be assessed using Numeric Rating Scale (NRS) from 0-10 with 0 as no pain and 10 as worst possible pain
Measured: 1 hour postoperative
Difference in pain score
Our secondary outcome is difference in pain scores at 24 hour between the two groups. The pain score will be assessed using Numeric Rating Scale (NRS) from 0-10 with 0 as no pain and 10 as worst possible pain
Measured: 24 hours postoperative
Difference in amount of pain killers used
Our secondary outcome is difference in the amount of pain killers used during the 24 hour period post operatively
Measured: pain killers used during the 24 hours postoperatively. The patient will be provided an empty sheet to record everytime a pain killer is used including the type and dose of pain killer . The pain killers are prescribed at the surgeon's discretion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start1 Oct 2020
- Primary completion5 Apr 2022
- Study completion5 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pedram Bral
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pedram Bral, Maimonides Medical Center
- Investigators
- Pedram Bral, MD, Principal investigator, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549090
- Sponsor's protocol ID
- 2020-02-01
- Status last verified
- Apr 2022
- First submitted
- 31 Aug 2020
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Posterior Quadratus Lumborum Block for Improved Postoperative Analgesia in Minimally Invasive Gynecologic Surgery
- ClinicalTrials.gov ID
- NCT04549090
- Acronym / sponsor ID
- 2020-02-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Pedram BralUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 16 Sep 2020 (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.
The challenge to achieve adequate analgesia has led to the development of directed, multi-modal protocols specific to management of post-laparoscopy pain in effort to decrease the amount of additional administration of narcotic medication. While several non-opioid regiments have been found to be effective, opioid medications still play a significant role in early postoperative analgesia. Given the adverse side effects of narcotic medications, regional blocks utilizing local anesthetic agents and has been shown to improve overall pain control in this time period.
Truncal abdominal nerve blocks are useful for pain control in abdominal and pelvic surgeries. More recently, the utilization of the quadratus lumborum (QL) block has effectively alleviated somatic and visceral pain in the upper and lower abdomen. The QL block provides analgesia spanning from the T4 to L1 dermatomal levels in the thoracolumbar plane to provide a broad sensory level analgesic effect. The approach involves injecting local anesthetic under ultrasound guidance into the plane posterior to the quadratus lumborum muscle and middle layer of thoracolumbar fascia.
Given the utility of the QL block in controlling somatic pain, this study aims to determine whether the QL block is an effective analgesic adjunct in the control of postoperative pain period, specifically with regards to patients undergoing laparoscopic gynecologic surgery.
Detailed description
Prospective Cohort observational study. All patients that meet criteria for participation in this study will be screened: patients scheduled to undergo a laparoscopic hysterectomy for benign conditions by attending physicians in the division of Minimally Invasive Gynecologic Surgery. Based on surgeon's preference, and patient's consent, the patient is offered a QL block or not. Our aim is to follow the patient's pain scores post op and amount of oral pain medication used whether they received QL block or not. If the patient received the QL block then they will be considered part of the study arm. If the patient did not receive the QL block then they will be considered part of the control arm.
The QL block is best thought of as a volume or compartment block in that volumetric spread of LA along the fascial plane is associated with efficacy in blocking the thoracolumbar nerves between T7-L1. It can be reasonably assumed that this compartment is the same across patients and is not affected by the amount of subcutaneous or central fat present in the obese patient.
If a block is to be performed, the QL block will be performed using a 21G x 100mm Stimuplex needle under ultrasound guidance using a curvilinear probe. Subjects will be positioned in the semi-lateral position to facilitate access into the plane posterior to the quadratus lumborum muscle and middle layer of thoracolumbar fascia. The QL block will be administered via an in-plane approach and local anesthetic will be injected between the quadratus lumborum muscle and the middle layer of the thoracolumbar. The QL block will be in the operating room after induction prior to starting the scheduled surgical procedure. If the block is performed, it will include 20ml of 0.25% bupivacaine and 5ml of liposomal bupivacaine (Exparel) per side. The block will be done bilaterally therefore a total of 40ml of 0.25% bupivacaine and 10ml of liposomal bupivacaine (Exparel) will be administered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No QL block group | – | –These patients will not be receiving QL block based on their shared decision with their surgeon and anesthesiologist. Patients' pain scores and amount of pain killers will be followed up for 24 hours postoperatively |
| QL block group | – | Drug: QL (quadratus lumborum) block administrationThese patients will be receiving QL block based on their shared decision with their surgeon and anesthesiologist. Patients' pain scores and amount of pain killers will be followed up for 24 hours postoperatively |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between the ages of 18 to 65 scheduled to undergo laparoscopic or robotic total or supracervical hysterectomy for benign indications
Key inclusion criteria (1 listed)
- Patients will be eligible for recruitment if between the ages of 18 to 65 scheduled to undergo laparoscopic or robotic total or supracervical hysterectomy for benign indications. Only surgery for benign pathology will be considered to enrollment. No Malignancy cases will be included.
Key exclusion criteria (7 listed)
- 1. History of adverse reaction or allergy to Bupivacaine or liposomal bupivacaine
- 2. Medical contraindication to placement of QL block.
- 3. Suspicion of possible reproductive cancer with contraindication of morcellation of uterine tissue.
- 4. Significant medical condition or laboratory result that in the opinion of the Investigator indicate an increased vulnerability to study subject which exposes the subject to an unreasonable risk as a result of participating.
- 5. Any clinically significant condition uncovered during the surgery, such as excessive bleeding or decompensation, that might render the subject medically unstable to continue the study or complicate the subject's intraoperative or postoperative course.
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 |
|---|---|---|
| QL (quadratus lumborum) block administrationFo the QL block group, they will be receiving bilateral QL block. A total of 40ml of 0.25% bupivacaine (Marcaine) and 10ml of liposomal bupivacaine (Exparel) will be administered | Drug | QL block group |
Primary outcome
Difference in pain score
Time frame: 3 hours postoperative
Our primary outcome is difference in pain scores at 3 hours between the two groups. The pain score will be assessed using Numeric Rating Scale (NRS) from 0-10 with 0 as no pain and 10 as worst possible pain
3 secondary outcomes
Difference in pain score
Time frame: 1 hour postoperative
Difference in pain score
Time frame: 24 hours postoperative
Difference in amount of pain killers used
Time frame: pain killers used during the 24 hours postoperatively. The patient will be provided an empty sheet to record everytime a pain killer is used including the type and dose of pain killer . The pain killers are prescribed at the surgeon's discretion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
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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.
Pedram Bral, MD principal investigator
Maimonides Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-operative Pain and Gynecologic Surgery, run by Pedram Bral 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 1 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: finished, as of the sponsor's last update on 12 Apr 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in pain score (time frame: 3 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2022.