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Dexamethasone Plus Bupivacaine Versus Bupivacaine in Bilateral Trans-incisional Paravertebral Block in Lumbar Spine Surgeries .

Dexamethasone Plus Bupivacaine Versus Bupivacaine in Bilateral Trans-incisional Paravertebral Block in Lumbar Spine Surgeries, a Randomized Clinical Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04783194
Enrollment
50
Registered
2021-03-05
Start date
2021-03-15
Completion date
2022-10-20
Last updated
2022-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Brief summary

The purpose of this study is to compare addition of dexamethasone to bupivacaine versus bupivacaine alone for trans-incisional bilateral paravertebral block for postoperative analgesia in elective lumbar spine surgeries.

Interventions

DRUGDexamethasone+ Bupivacaine

Dexamethasone plus bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery.

DRUGBupivacaine

Bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* physical status American Society of Anesthesiologists (ASA) I or II.

Exclusion criteria

* refuse to participate have a body mass index (BMI) \>30 kg/m2 ASA physical status \>II have major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological) coagulation abnormalities infection at the injection site tumor in the paravertebral space sepsis Severe chest deformity or scoliosis, due to the possibility of injection into the meninges an allergy or contraindications to the drugs used in the study uncontrolled diabetes patients with active gastric ulceration a history of drug addiction or alcohol abuse a psychiatric illness mental retardation interfering with the evaluation of pain scores.

Design outcomes

Primary

MeasureTime frameDescription
First time to analgesic requirement1st 24 hourAfter extubation, an IV PCA system will be connected to the patient (Accufuser Plus® 100 mL: Woo Young Medical Co, Korea). PCA will be prepared with 60 mL of normal saline containing 60 mg of morphine, and the system will be programmed to give a 0.5 mL bolus dose with a lockout interval of 8 min. basal rate will not be present. PCA will be discontinued at 24 h after surgery, and at that time, oral analgesics begin.

Secondary

MeasureTime frameDescription
Total opioid consumption .1st 24 hourTotal opioid consumption in the first 24 h postoperatively .
Visual analogue scale (VAS)1st 24 hours postoperativelyPain scores will be evaluated by a blinded observer anesthesiologist at the time of arrival in the PACU and 10, 20, and 30 min and 1, 2, 4, 6, 12, and 24 h thereafter using a visual analog scale (VAS) (ranging from0-10 cm: where 0 = no pain, 10 = worst pain). The patients Will be instructed about the usage of the PCA system and the VAS preoperatively

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026