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

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Drug: Bupivacaine; Drug: Dexamethasone+ Bupivacaine

• Registration Number: NCT04783194
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-28
• Study First Submitted QC: 2021-03-03
• Study First Posted: 2021-03-05
• Study Start: 2021-03-15
• Primary Completion: 2022-09-15
• Study Completion: 2022-10-20
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-20
• Last Update Posted: 2022-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine in bilateral TiPVB in lumbar spine surgery	Bupivacaine	Bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery for postoperative analgesia
Dexamethasone + bupivacaine in bilateral TiPVB in lumbar spine surgery	Dexamethasone+ Bupivacaine	Dexamethasone plus bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery for postoperative analgesia

Primary Outcome Measures

Name	Time	Method
First time to analgesic requirement	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 Outcome Measures

Name	Time	Method
Total opioid consumption .	1st 24 hour	Total opioid consumption in the first 24 h postoperatively .
Visual analogue scale (VAS)	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

Trial Locations

Locations (1)

Ain Shams University hospitals; 🇪🇬 Cairo, Egypt