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

NCT06021327 | Unknown

• 1 other identifier: MD-327-2022
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

RLB; ESPB; VATS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• • Time is required to perform the technique in minutes.

  intraoperative

• Heart Rate

  intraoperative and 24 hours postoperative

• Systolic arterial blood pressure

  intraoperative and 24 hours postoperative

• Diastolic arterial blood pressure

  intraoperative and 24 hours postoperative

• Mean arterial blood pressure

  intraoperative and 24 hours postoperative

Study Arms (2)

Erector spinae plane block

ACTIVE COMPARATOR

will receive a US-guided ESPB

Procedure: Erector spinae plane block

Retrolaminar block

ACTIVE COMPARATOR

will receive a US-guided RLB

Procedure: Retrolaminar block

Interventions

Erector spinae plane block PROCEDURE

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.

Erector spinae plane block

Retrolaminar block PROCEDURE

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.

Retrolaminar block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Facalty of Medicine - Cairo University

Cairo, Egypt

RECRUITING

Related Publications (17)

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Study Officials

• Islam M Sayed, MS

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Islam M Sayed, MS

CONTACT

00201008039448; i.sharr866@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: i.sharr866@gmail.com

Study Record Dates

• First Submitted: June 17, 2023
• First Posted: September 1, 2023
• Study Start: February 1, 2023
• Primary Completion: October 30, 2023
• Study Completion: December 30, 2023
• Last Updated: September 1, 2023

Record last verified: 2023-08

Locations

EG (1)