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

Not Applicable

Recruiting

• Conditions: VATS; Erector Spinae Plan Block; Post-operative Analgesia; Retrolaminar Block
• Interventions: Procedure: Erector spinae plane block; Procedure: Retrolaminar block

• Registration Number: NCT06021327
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2023-06-17
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-25
• Last Update Submitted: 2023-08-25
• Study First Posted: 2023-09-01
• Last Update Posted: 2023-09-01
• Primary Completion: 2023-10-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erector spinae plane block	Erector spinae plane block	will receive a US-guided ESPB
Retrolaminar block	Retrolaminar block	will receive a US-guided RLB

Primary Outcome Measures

Name	Time	Method
Total amount of morphine consumption in milligram in the first 24-hour postoperative in the two groups	24-hour	ESPB compared to RLB for postoperative analgesia after VATS

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Facalty of Medicine - Cairo University; 🇪🇬 Cairo, Egypt