Comparing General Anesthesia, General Anesthesia With ESP Block or TLIP Block in Patients Undergoing Lumbar Surgeries

Anesthesia Research Group UA

Status: Enrolling

Conditions: Lumbar Discogenic Pain; Lumbar Spinal Stenosis; Lumbar Disc Herniation; Failed Back Surgery Syndrome

Treatments: Procedure: regional anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT05447780

1718042022

Details and patient eligibility

About

The regional methods of anesthesia for the neurosurgical operations of the spine and spinal cord reducing the needs for opioids intra operatively and reducing pain in the postoperative period, decrease the numbers of failed back syndrome.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• back surgery

Exclusion criteria

• contraindications to the regional method of analgesia,
• patient refusal,
• patients with diabetes mellitus
• mental illness
• pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

450 participants in 3 patient groups

General anesthesia

Experimental group

Description:

induction: propofol 1.5-2.5 mg\\kg IV bolus and fentanyl 1-2 mcg\\kg maintenance anesthesia: sevoflurane, doses of the inhalation agent according to bispectral index (BIS) monitor ( target BIS level 40-60) and fentanyl 1-5 mcg\\kg\\h.

Treatment:

Procedure: regional anesthesia

Combined anesthesia: general anesthesia and Erector spinae plane block (ESP block)

Experimental group

Description:

induction: propofol 1.5-2.5 mg\\kg IV bolus and fentanyl 1-2 mcg\\kg ESP- block with US control with single shot of local anesthetic ( bupivacaine 0.375% or 0.25% 20-30 ml) is performed after induction. maintenance anesthesia: sevoflurane, doses of the inhalation agent according to BIS monitor ( target BIS level 40-60) and fentanyl 0.5-1.5 mcg\\kg\\h.

Treatment:

Procedure: regional anesthesia

Combined anesthesia: General anesthesia and Thoraco-lumbar interfacial plane block (TLIP block)

Experimental group

Description:

induction: propofol 1.5-2.5 mg\\kg IV bolus and fentanyl 1-2 mcg\\kg TLIP- block with US control with single shot of local anesthetic ( bupivacaine 0.25% 15 ml or mixed bupivacaine 0.25% 7.5 ml and lidocaine 2% 7.5 ml) is performed after induction. maintenance anesthesia: sevoflurane, doses of the inhalation agent according to BIS monitor ( target BIS level 40-60) and fentanyl 0.5-1.5 mcg\\kg\\h.

Treatment:

Procedure: regional anesthesia