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Completed

NCT Number: NCT04783194

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

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.

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Key information

Conditions

Anesthesia

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University hospitals

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone+ Bupivacaine

Drug

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

Bupivacaine

Drug

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

Primary outcomes

  1. First time to analgesic requirement

    Time frame: 1st 24 hour

    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.

Secondary outcomes

  1. Total opioid consumption .

    Time frame: 1st 24 hour

    Total opioid consumption in the first 24 h postoperatively .

  2. Visual analogue scale (VAS)

    Time frame: 1st 24 hours postoperatively

    Pain 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 5, 2021
Registry last updated
Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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