Clinical trial NCT06021327: Comparison Between Erector Spinae Plane Block And Retrolaminar Block In Patients Undergoing VATS.
Official title: Comparison Of The Analgesic Effect Of Ultrasound-Guided Erector Spinae Plane Block And Ultrasound-Guided Retrolaminar Block In Patients Undergoing Video Assisted Thoracoscopic Surgery: A Prospective, Randomized Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-operative Analgesia
Retrolaminar Block
Erector Spinae Plan Block
VATS
Keywords: RLB
ESPB
VATS
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Post-Video-assisted thoracoscopic surgery pain is a challenging clinical problem that may be associated with increased morbidity and mortality. The current study tests two techniques of regional anaesthesia to control post Video-assisted thoracoscopic surgery pain

Detailed description: Video-assisted thoracoscopic surgery (VATS) is increasingly being used to manage primary lung cancer and helps reduce postoperative pain. However, it is a fact that pain following VATS can be severe and long-lasting. According to previous study, 18.8% of patients who undergo VATS present with persistent pain 2 months after surgery .The provision of pain relief is a significant consideration, and thoracic epidural analgesia is often regarded to be the gold standard. However, epidural analgesia is not always ideal, and other practical regional methods of analgesia after VATS have been proposed as Erector Spinae Plane Block (ESPB) or retrolaminar block (RLB) .

The retrolaminar block (RLB) is a modified paravertebral block that administers local anesthetic between the lamina of the thoracic vertebra and the erector spinal muscles, using landmark technique or under ultrasound guidance. Previous clinical study reported that RLB provides a good analgesic effect after VATS but was inferior to para-vertebral block(PVB).

Erector spinae plane block (ESPB) is a relatively new interfascial block procedure first described for thoracic analgesia. Previous clinical studies reported that ESPB provides a good analgesic effect after VATS (comparable with PVB) and decreases morphine consumption after Lateral thoracotomy surgery. Thus, anaesthesiologists now have a greater choice for regional anaesthesia for thoracic analgesia. Although ESPB and RLB have similar puncture sites, Only one clinical study comparing ESPB and RLB in breast surgery has been reported , The mentioned study was also limited only to female patients. both blocks were compared with PVB but There is no clinical study that compares ESPB and RLB directly in VATS. Although the mechanisms of action of both ESPB and RLB have not yet been completely clarified, one cadaveric study indicated that ESPB leads to a broader spread of the local analgesic into a more extensive range of intercostal spaces from a single point of injection than RLB . Another cadaveric study reported that the lateral pathway, which is involved in the blockade of the intercostal nerve or the lateral cutaneous branches of the intercostal nerves, is the primary mechanism of ESPB, in contrast to RLB.

Based on these anatomical studies, we hypothesize that ESPB can be superior to RLB for postoperative analgesia after VATS.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status class (ASA) I, II and III
* Patients undergoing VATS.

Exclusion Criteria:

1. Patient refusal
2. Coagulopathy, bleeding disorders,
3. In-ability to postpone anti-coagulation medications.
4. infection at the injection site
5. pregnancy, breastfeeding,
6. severe obesity (body mass index \> 35 kg/m2 )
7. allergy to any drug used in the study
8. preoperative daily use of a non-steroidal anti-inflammatory drug (NSAID) or opioids,
9. Previous surgery in the thoracic vertebral region
10. Liver dysfunction.
11. Injury or a lesion at the block site.

Primary outcomes:
measure: Total amount of morphine consumption in milligram in the first 24-hour postoperative in the two groups
timeFrame: 24-hour
Secondary outcomes:
measure: • Time is required to perform the technique in minutes.
timeFrame: intraoperative
measure: Heart Rate
timeFrame: intraoperative and 24 hours postoperative
measure: Systolic arterial blood pressure
timeFrame: intraoperative and 24 hours postoperative
measure: Diastolic arterial blood pressure
timeFrame: intraoperative and 24 hours postoperative
measure: Mean arterial blood pressure
timeFrame: intraoperative and 24 hours postoperative
measure: • Intraoperative cardioactive drug use
timeFrame: Intraoperative
measure: • Intraoperative analgesics
timeFrame: Intraoperative
measure: • Pain score according to VAS score
timeFrame: 24 hours
measure: • First request of analgesia postoperative
timeFrame: 24 hours Postoperative
measure: • Incidence of side effects related to opioid use
timeFrame: 24 hours Postoperative
measure: • Incidence of complications or side-effects related to the block
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Facalty of Medicine - Cairo University
Study officials:
affiliation: Cairo University
name: Islam M Sayed, MS
role: PRINCIPAL_INVESTIGATOR
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