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

NCT04783194 | Completed

• 1 other identifier: FMASU R 47/2020/2021
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• First time to analgesic requirement

  After 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.

  1st 24 hour

Secondary Outcomes (2)

• Total opioid consumption .

  1st 24 hour

• Visual analogue scale (VAS)

  1st 24 hours postoperatively

Study Arms (2)

Dexamethasone + bupivacaine in bilateral TiPVB in lumbar spine surgery

ACTIVE COMPARATOR

Dexamethasone plus bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery for postoperative analgesia

Drug: Dexamethasone+ Bupivacaine

Bupivacaine in bilateral TiPVB in lumbar spine surgery

ACTIVE COMPARATOR

Bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery for postoperative analgesia

Drug: Bupivacaine

Interventions

Dexamethasone+ Bupivacaine DRUG

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

Dexamethasone + bupivacaine in bilateral TiPVB in lumbar spine surgery

Bupivacaine DRUG

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

Bupivacaine in bilateral TiPVB in lumbar spine surgery

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University hospitals

Cairo, Egypt

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: February 28, 2021
• First Posted: March 5, 2021
• Study Start: March 15, 2021
• Primary Completion: September 15, 2022
• Study Completion: October 20, 2022
• Last Updated: December 21, 2022

Record last verified: 2022-12

Locations

EG (1)