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

Post-operative Analgesia Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06021327
• Other study ID #: MD-327-2022
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: August 2023
• Source: Cairo University
• Contact: Islam M Sayed, MS
• Phone: 00201008039448
• Email: i.sharr866[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Post-operative Analgesia
• Retrolaminar Block

Intervention

Procedure:
• Erector 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.
• Retrolaminar block
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.

Locations

Country	Name	City	State
Egypt	Facalty of Medicine - Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (17)

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Chen N, Qiao Q, Chen R, Xu Q, Zhang Y, Tian Y. The effect of ultrasound-guided intercostal nerve block, single-injection erector spinae plane block and multiple-injection paravertebral block on postoperative analgesia in thoracoscopic surgery: A randomized, double-blinded, clinical trial. J Clin Anesth. 2020 Feb;59:106-111. doi: 10.1016/j.jclinane.2019.07.002. Epub 2019 Jul 19. — View Citation

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Ivanusic J, Konishi Y, Barrington MJ. A Cadaveric Study Investigating the Mechanism of Action of Erector Spinae Blockade. Reg Anesth Pain Med. 2018 Aug;43(6):567-571. doi: 10.1097/AAP.0000000000000789. — View Citation

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Onishi E, Toda N, Kameyama Y, Yamauchi M. Comparison of Clinical Efficacy and Anatomical Investigation between Retrolaminar Block and Erector Spinae Plane Block. Biomed Res Int. 2019 Mar 28;2019:2578396. doi: 10.1155/2019/2578396. eCollection 2019. — View Citation

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Shim JG, Ryu KH, Kim PO, Cho EA, Ahn JH, Yeon JE, Lee SH, Kang DY. Evaluation of ultrasound-guided erector spinae plane block for postoperative management of video-assisted thoracoscopic surgery: a prospective, randomized, controlled clinical trial. J Thorac Dis. 2020 Aug;12(8):4174-4182. doi: 10.21037/jtd-20-689. — View Citation

Sotome S, Sawada A, Wada A, Shima H, Kutomi G, Yamakage M. Erector spinae plane block versus retrolaminar block for postoperative analgesia after breast surgery: a randomized controlled trial. J Anesth. 2021 Feb;35(1):27-34. doi: 10.1007/s00540-020-02855-y. Epub 2020 Sep 11. — View Citation

Taketa Y, Irisawa Y, Fujitani T. Comparison of ultrasound-guided erector spinae plane block and thoracic paravertebral block for postoperative analgesia after video-assisted thoracic surgery: a randomized controlled non-inferiority clinical trial. Reg Anesth Pain Med. 2019 Nov 8:rapm-2019-100827. doi: 10.1136/rapm-2019-100827. Online ahead of print. — View Citation

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* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total amount of morphine consumption in milligram in the first 24-hour postoperative in the two groups	ESPB compared to RLB for postoperative analgesia after VATS	24-hour
Secondary	• Time is required to perform the technique in minutes.	between the start of US scanning and the local anesthetic injection	intraoperative
Secondary	Heart Rate	Heart 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.	intraoperative and 24 hours postoperative
Secondary	Systolic arterial blood pressure	Systolic 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.	intraoperative and 24 hours postoperative
Secondary	Diastolic arterial blood pressure	Diastolic 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.	intraoperative and 24 hours postoperative
Secondary	Mean arterial blood pressure	Mean 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.	intraoperative and 24 hours postoperative
Secondary	• Intraoperative cardioactive drug use	The number of patients requiring ephedrine and atropine	Intraoperative
Secondary	• Intraoperative analgesics	The number of patients requiring additional doses of fentanyl. Total intraoperative IV fentanyl dose (above the standard two microgram / kilogram )	Intraoperative
Secondary	• Pain score according to VAS score	VAS value obtained from the patient immediately after recovery from anesthesia then every 4 hours during the first 24 hours postoperatively.	24 hours
Secondary	• First request of analgesia postoperative	The elapsed time from the block procedure until the administration of the first postoperative rescue analgesia in hours	24 hours Postoperative
Secondary	• Incidence of side effects related to opioid use	(postoperative nausea and vomiting (PONV), constipation, pruritus, urinary retention) in postoperative time.	24 hours Postoperative
Secondary	• Incidence of complications or side-effects related to the block	(bradycardia, hypotension, hematoma formation or intravascular injection).	24 hours