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Comparison of Ultrasound-guided Erector Spinae Plane Block and Transmuscular Quadratus Lumborum Block

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05709899
Collaborator
(none)
44
Enrollment
2
Arms
33.1
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The objective of this study is to compare the postoperative analgesic effect of bupivacaine injection via ultrasound-guided erector spinae block versus transmuscular quadratus lumborum block in patients undergoing abdominal cancer surgery

Condition or Disease Intervention/Treatment Phase
  • Other: nerve blocks
 N/A

Detailed Description

Surgical trauma activates numerous receptors leading to severe postoperative pain. Therefore, effective pain management is a priority of care and a patient right .

Postoperative pain may cause tachycardia, hypertension, increased cardiac work, nausea, vomiting, ileus. Also if it is inadequately managed may lead to detrimental Cardiovascular effects, pulmonary dysfunction, immune system, neuro-endocrine and metabolic effects, gastrointestinal, urinary dysfunction, coagulation system , cognitive dysfunction and also have psychological, economic and social adverse effects Good postoperative analgesia can prevent morbidity associated with abdominal surgeries by allowing pain-free, early ambulation and decreasing the risks of long hospital stay, thromboembolism, and other poor outcomes.

Adequate pain treatment is an important component of modern perioperative care and essential for a fast recovery. Choosing the optimal analgesic modality remains a topic of debate especially in major abdominal surgeries.

Various techniques have been tried to replicate the analgesic efficacy of TEA. They include transversus abdominis plane analgesia (TAP), rectus sheath analgesia (RS), wound infusion analgesia (WI) and transmuscular quadratus lumborum (TQL) analgesia.

However each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for all open abdominal surgeries.

The ultrasound (US)-guided erector spinae plane block (ESPB) was initially described by Forero et al.It as a relatively new technique, originally described to manage thoracic pain when performed at the T5 vertebra level, but it has also been successfully used for abdominal analgesia when performed at T7 level.

ESPB gained wide attention as it is a faster procedure that carries a lower risk of hypotension, can be used in patients with coagulopathy, easy to perform, and requires less training.

ESPB provides extensive, potent unilateral analgesia, performed by local anesthetic injection in the plane between the erector spinae muscle and the TP. The local anesthetic diffuses into the paravertebral space through spaces between adjacent vertebrae and blocks both the dorsal and ventral rami of the thoracic spinal nerves.

Bilateral ESPB performed at low thoracic levels provides satisfactory analgesia for abdominal surgeries in case reports and series describing abdominal exploration, cesarean section, ventral hernia repair, and abdominoplasty.

As LA widely spreads cranially and caudally when ESPB is performed, we think that ESPB can effectively be used as an analgesic method for abdominal surgeries.

The ultrasound-guided (USG) quadratus lumborum block QLB was first described by Rafael Blanco in a presentation at ESRA 2007 at the XXVI Annual ESRA Congress in Valencia, Spain. Blanco described a potential space posterior to the abdominal wall muscles and lateral to the quadratus lumborum muscle (QL) where Local anesthetics (LA) can be injected. This technique provides analgesia after abdominal surgeries due to spread of LA from its lumbar deposition cranially into the thoracic paravertebral space (TPVS) where lateral and anterior cutaneous branches from Th7 to L1 nerves can be blocked. This was proved later by Carney et al. who found traces of contrast agent in the TPVS following the block.

Quadratus lumborum block (QLB) under ultrasound has been one of the interfascial plane blocks being popularized in regional anesthesia over the last few years given the vast number of indications in a variety of abdomino-pelvic surgeries in pediatrics and adults. In clinical studies, it also has been shown to have opioid sparing effects and prolonged post-operative analgesia than more conventional procedures like TAP blocks.

Several approaches have been described for QLB. Lateral QLB (or QLB-1) where local anesthetic is injected at the anterolateral border of the QL muscle. Posterior QLB (or QLB-2) where LA is injected at the junction of QL muscle with the transversalis fascia., Another novel approach is the transmuscular QLB (or QLB-3), where the needle is advanced through the QL muscle, penetrating the ventral proper fascia of the QL muscle and LA is finally injected between the QL muscle and Psoas Major (PM) muscle. It is thought that this approach (QLB-3) does not result in redundant antero-lateral spread of the LA.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Comparison of Ultrasound-guided Erector Spinae Plane Block and Transmuscular Quadratus Lumborum Block in Abdominal Cancer Surgeries.
Anticipated Study Start Date :
Mar 30, 2023
Anticipated Primary Completion Date :
Nov 30, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: Group I : Bilateral erector spinae plane block.

Ultrasound (US) will be used to identify the level of T8 after skin sterilization with the patient on the lateral position. A high frequency linear-array US transducer covered in a sterile sleeve will be placed in a longitudinal parasagittal orientation 3 cm lateral to the midline to identify the trapezius above, the rhomboid major in the middle, and the erector-spinae muscle on the bottom, and the transverse Processes with shimmering pleura in between. 2-3 ml of 2% lidocaine "depocaine HCL" will be infiltrated.16-G, 8-cm Tuohy needle will be then introduced medially in the plane of the US beam and directed towards the transverse process. Once the needle is underneath the anterior fascia of the erector spinae muscle. 20 ml of bupivacaine 0.5% "sunnypivacaine" will be injected in this potential space over five minutes. The injectate will be observed spreading underneath the ES muscle lifting the muscle of the transverse process. This will be repeated on the opposite side.

Other: nerve blocks
Comparison of ultrasound-guided erector spinae plane block and transmuscular quadratus lumborum block for postoperative analgesia in abdominal cancer surgeries.
Other: Group II : Transmuscular quadratus lumborum block

Patient will be positioned in left lateral to obtain appropriate view of QL. Aseptic precautions will be taken by wearing sterile gown and sterile drapes. By using Ultrasound MacroMaxx™ with linear probe (HFL38_10-5 MHz) covered with sterile plastic sheath SiteRite placed in the anterior axillary line to visualize the typical triple abdominal layers. Then, the probe will be placed in the midaxillary line and at this juncture the layers of abdominal layers will start to taper. When the probe will be placed in the posterior axillary line as per the posterior approach, sonoanatomy will show first the transversus abdominis disappearing then the internal oblique and external oblique forming aponeurosis and appearance of QL noticed. At the junction of the tapered ends of abdominal muscles and QL, a 21 g 100 mm SonoPlexStimu cannula needle will be inserted in plane. Under ultrasound guidance, in that space 20 mL of 0.5% bupivacaine "sunnypivacaine"will be injected separating the fascia.

Other: nerve blocks
Comparison of ultrasound-guided erector spinae plane block and transmuscular quadratus lumborum block for postoperative analgesia in abdominal cancer surgeries.

Outcome Measures

Primary Outcome Measures

  1. postoperative analgesia [First 48 hours after surgery.]

    to assess pain intensity at rest and during pain-provoking movements (deep breathing, coughing, mobilization) measured by VAS pain score (a visual analog scale scored from 0 to 10 where 0 = no pain and 10 = the worst pain imaginable) during the first 48 hours postoperatively.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. Patients subjected to abdominal cancer surgery.

  2. The enrolled age will be from 18 years to 70 years.

  3. ASA I-II and NYHA I-II.

Exclusion Criteria:

  1. ASA physical status >II, and NYHA >II.

  2. Patient refusal.

  3. body mass index >40 kg/m2.

  4. preoperative opioid consumption.

  5. a local infection at the incision site.

  6. a history of hematological disorders or coagulation abnormality.

  7. previous abdominal surgeries, severe hepatic or renal impairment

  8. Anomalies of vertebral column.

  9. Pregnant women.

  10. Hypersensitivity to any of used drugs.

  11. chronic pain.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Rana Ahmed Hamed Mohamed, principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05709899
Other Study ID Numbers:
  • postoperative analgesia
First Posted:
Feb 2, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Colonic Neoplasms

Study Results

No Results Posted as of Feb 8, 2023