Dexmedetomidine Combined With Bupivacaine for Erector Spinae Plane Block

October 6 University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Posterior Lumbosacral Spine Fixation Surgeries

Treatments: Drug: Dexmedetomidine injection; Drug: Bupivacaine 0.25% Injectable Solution; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05590234

PRC-Me-2210035

Details and patient eligibility

About

As the posterior lumbosacral spine fixation surgeries are common spine procedures done nowadays due to different causes and as this spine procedure is mostly accompanied with moderate to severe postoperative pain, so it is necessary to find an effective and efficient postoperative analgesia for patients with this surgery.

Enrollment: 90 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• elective posterior lumbosacral spine fixation and fusion surgery due to different causes that diagnosed clinically and radiologically including MRI and Plain X ray

Exclusion criteria

• hypersensitivity to the drugs used in the study [local anesthetics, non-steroidal anti-inflammatory drugs, opioids and the drug under investigation (dexmedetomidine)]
• patients with any contraindication to regional anesthesia as skin infections at the site of the block
• history of bleeding disorders or receiving anticoagulant medications

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

Dexmedetomidine combined with bupivacaine group (DB group)

Active Comparator group

Description:

patients received 1ug/kg dexmedetomidine plus 20 mL of bupivacaine 0.25%,

Treatment:

Drug: Dexmedetomidine injection

Drug: Bupivacaine 0.25% Injectable Solution

bupivacaine 0.25%,

Active Comparator group

Description:

patients received 20 ml of bupivacaine 0.25%

Treatment:

Drug: Bupivacaine 0.25% Injectable Solution

control group (S group)

Placebo Comparator group

Description:

patients received 20 ml of normal saline 0.9%.

Treatment:

Drug: normal saline