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Comparison Between Erector Spinae Plane Block And Retrolaminar Block In Patients Undergoing VATS.

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06021327
Enrollment
44
Registered
2023-09-01
Start date
2023-02-01
Completion date
2023-12-30
Last updated
2023-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative Analgesia, Retrolaminar Block, Erector Spinae Plan Block, VATS

Keywords

RLB, ESPB, VATS

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.

Interventions

PROCEDUREErector spinae plane block

Under aseptic precautions, the ultrasound transducer will be placed on the patient's back in a longitudinal paramedian orientation approximately 3 cm from the midline. A short-bevel, 80 mm 22-gauge insulated nerve block needle will be inserted using an in-plane approach to contact the tip of the T4 transverse process , After negative aspiration of blood, a total of 20 mL of 0.25% bupivacaine will be injected through the needle. Adequacy of the block will be confirmed by ultrasonographic visualization of fluid spread (seen as a lifting of the erector spina muscles in both block) and after 15 min, documenting the sensory blockade will be done by using a piece of ice or cold object. If the desired sensory level fails to be achieved (T4 - T8), patients will be excluded from the study.

Under aseptic precautions, the ultrasound transducer will be placed on the patient's back in a longitudinal paramedian orientation approximately 1 cm from the midline. A short-bevel, 80 mm 22-gauge insulated nerve block needle will be inserted using an in-plane approach to contact T4 lamina of the vertebra , After negative aspiration of blood, a total of 20 mL of 0.25% bupivacaine will be injected through the needle. And after 15 min, documenting the sensory blockade will be done by using a piece of ice or cold object. If the desired sensory level fails to be achieved (T4 - T8), patients will be excluded from the study.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Masking description

Patients will be randomized using a computer-generated list of random numbers, which will be sealed in closed envelopes. Patients will be randomly allocated to one of two groups; Group I (E) will receive a US-guided ESPB, while Group II (R) will receive a US-guided RLB. An anesthesiologist who is not involved in the data collection team will perform all nerve blocks. Intra- and postoperative data will be collected by an anesthesiologist or intensivist who is blinded to the study protocol.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Total amount of morphine consumption in milligram in the first 24-hour postoperative in the two groups24-hourESPB compared to RLB for postoperative analgesia after VATS

Secondary

MeasureTime frameDescription
• Time is required to perform the technique in minutes.intraoperativebetween the start of US scanning and the local anesthetic injection
Heart Rateintraoperative and 24 hours postoperativeHeart rate (Bpm) at15 minutes after blocks are done before the induction (baseline), immediately after intubation, every 10 minutes intraoperative, immediately after extubation, and every 4 hour in the ICU for the first 24 hours.
Systolic arterial blood pressureintraoperative and 24 hours postoperativeSystolic arterial blood pressure in millimetre mercury at15 minutes after blocks are done before the induction (baseline), immediately after intubation, every 10 minutes intraoperative, immediately after extubation, and every 4 hour in the ICU for the first 24 hours.
Diastolic arterial blood pressureintraoperative and 24 hours postoperativeDiastolic arterial blood pressure in millimetre mercury at15 minutes after blocks are done before the induction (baseline), immediately after intubation, every 10 minutes intraoperative, immediately after extubation, and every 4 hour in the ICU for the first 24 hours.
Mean arterial blood pressureintraoperative and 24 hours postoperativeMean arterial blood pressure in millimetre mercury at15 minutes after blocks are done before the induction (baseline), immediately after intubation, every 10 minutes intraoperative, immediately after extubation, and every 4 hour in the ICU for the first 24 hours.
• Incidence of side effects related to opioid use24 hours Postoperative(postoperative nausea and vomiting (PONV), constipation, pruritus, urinary retention) in postoperative time.
• Intraoperative analgesicsIntraoperativeThe number of patients requiring additional doses of fentanyl. Total intraoperative IV fentanyl dose (above the standard two microgram / kilogram )
• Pain score according to VAS score24 hoursVAS value obtained from the patient immediately after recovery from anesthesia then every 4 hours during the first 24 hours postoperatively.
• First request of analgesia postoperative24 hours PostoperativeThe elapsed time from the block procedure until the administration of the first postoperative rescue analgesia in hours
• Incidence of complications or side-effects related to the block24 hours(bradycardia, hypotension, hematoma formation or intravascular injection).
• Intraoperative cardioactive drug useIntraoperativeThe number of patients requiring ephedrine and atropine

Countries

Egypt

Contacts

Primary ContactIslam M Sayed, MS
i.sharr866@gmail.com00201008039448

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026