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

Sponsor
Ain Shams University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04783194
Collaborator
(none)
50
1
2
20.1
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Dexamethasone Plus Bupivacaine Versus Bupivacaine in Bilateral Trans-incisional Paravertebral Block in Lumbar Spine Surgeries, a Randomized Clinical Trial.
Actual Study Start Date :
Feb 15, 2021
Anticipated Primary Completion Date :
Sep 15, 2022
Anticipated Study Completion Date :
Oct 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Dexamethasone + bupivacaine in bilateral TiPVB in lumbar spine surgery

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

Drug: Dexamethasone+ Bupivacaine
Dexamethasone plus bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery.

Active Comparator: Bupivacaine in bilateral TiPVB in lumbar spine surgery

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

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

Outcome Measures

Primary Outcome Measures

  1. First time to analgesic requirement [1st 24 hour]

    After extubation, an IV PCA system will be connected to the patient (Accufuser PlusĀ® 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

  1. Total opioid consumption . [1st 24 hour]

    Total opioid consumption in the first 24 h postoperatively .

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ain Shams University hospitals Cairo Egypt

Sponsors and Collaborators

  • Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amin Mohammed Alansary Amin Ahmed Helwa, Assistant professor, Ain Shams University
ClinicalTrials.gov Identifier:
NCT04783194
Other Study ID Numbers:
  • FMASU R 47/2020/2021
First Posted:
Mar 5, 2021
Last Update Posted:
Jul 8, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 8, 2022