Quadratus Lumborum Nerve Blocks for Myomectomies

Laparoscopic Myomectomy Clinical Trial

Official title:

Quadratus Lumborum Nerve Blocks in Laparoscopic Myomectomy Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03935815
• Other study ID #: 18-000825
• Status: Terminated
• Phase: Phase 1
• Start date: May 1, 2019
• Est. completion date: June 8, 2020

Study information

• Verified date: April 2021
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: June 8, 2020
• Est. primary completion date: June 6, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) physical status 1-2,

• Female,

• greater than or equal to 18 years of age,

• undergoing laparoscopic myomectomy surgery

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Laparoscopic Myomectomy
• Quadratus Lumborum Nerve Block

Intervention

Drug:
• Ropivacaine injection
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.

Procedure:
• Sham treatment
A sham procedure with a superficial 22 gauge needle stick will be performed without injectate.

Locations

Country	Name	City	State
United States	Ronald Reagan UCLA Medical Center, Department of Anesthesiology	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

Carvalho R, Segura E, Loureiro MD, Assunção 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. — View Citation

Chakraborty 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. — View Citation

Kadam 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. — View Citation

Visoiu 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine equivalents (MOE) consumption	The patient's cumulative intake of morphine over 24 hours.	Up to 24 hours after surgery
Secondary	Pain Score	Rate of pain on a scale of 0-10 (0 is no pain and 10 is the worst pain possible)	Up to 48 hours after surgery