Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000768291
Ethics application status
Approved
Date submitted
22/02/2018
Date registered
7/05/2018
Date last updated
7/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
To compare the pain relief in spine surgery from a pain killer drug (Ropivacaine) with a placebo (Normal Saline) delivered regionally at the transverse process of the operated vertebrae.
Scientific title
Comparison of Gelatin Sponge Impregnated with Ropivacaine Versus Normal Saline Applied Intraoperatively on The Transverse Process of The Operated Vertebrae at The End of Surgery on The Postoperative Pain in patients undergoing spinal instrumentation surgery: A Randomised Clinical Trial.
Secondary ID [1] 294135 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Degenerative lumbar spine condition 306757 0
Postoperative pain 306758 0
lumbosacral instrumentation surgery 306759 0
Condition category
Condition code
Anaesthesiology 305852 305852 0 0
Pain management
Surgery 306716 306716 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Application by the surgeon of gelatine foam impregnated with ropivacaine, a local anesthetic, at a dose of 1,5ml of ropivacaine 0,5%, on the transverse process of the operated vertebrae at the end of surgery before closure of the surgical field..
Intervention code [1] 300424 0
Treatment: Drugs
Comparator / control treatment
Application by the surgeon of gelatine foam impregnated with normal saline, at a dose of 1,5 ml per vertebrae operated, on the transverse process of the operated vertebrae at the end of surgery before closure of the surgical field.
Control group
Placebo

Outcomes
Primary outcome [1] 304901 0
100 mm visual analogue pain score post spine surgery
Timepoint [1] 304901 0
Post operative numeric rating score of pain after discharge from the Post anesthesia Care Unit. Time-frame: 48 hour post discharge from the Post Anesthesia Care unit..
Primary outcome [2] 304902 0
Total consumption of narcotics 48 hours after discharge from Post anesthesia Care Unit. Narcotic was given intramuscular if the 100 visual analogue pain scale is above 40. This outcome i.e the total consumption dose of meperidine is taken from the hospital records.
Timepoint [2] 304902 0
Total consumption of narcotics post operatively after discharge from the Post anesthesia Care Unit. Time-frame: 48 hour post discharge from the Post Anesthesia Care unit..
Secondary outcome [1] 343561 0
sit-to-stand test:
. 1. Sit in the middle of the chair with your feet flat on the
floor
2.. Rise to a full stand and return to a complete sitting
position.
0 = inability to rise from a chair.
1 = inability to stand without assistance.
2 = ability to stand alone.
Timepoint [1] 343561 0
Time frame: 48 hours after discharge from the Post Anesthesia Care Unit.
Secondary outcome [2] 343562 0
Side Effects: Nausea and vomiting self reported by Likert scale.
Timepoint [2] 343562 0
Time frame: 48 hours after discharge from the Post Anesthesia Care Unit.

Eligibility
Key inclusion criteria
Patients undergoing spinal intrumentation surgery under general anesthesia.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
:Previous spinal surgery,
Spinal tumor surgery,
Refusal of the patient.
History of allergy to local anesthetic..

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The syringes filled with ropivacaine 0,5% or normal saline were numerated according to a hazard table by an anesthesia technician unaware of the study and given to the surgeon to impregnate the gelatin foam to apply on the transverse process of the operated vertebrae on both sides..
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software to numerate the syringes filled with ropivacaine 0,5% or normal saline.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
9/02/2018
Date of last participant enrolment
Anticipated
22/05/2018
Actual
Date of last data collection
Anticipated
31/05/2018
Actual
Sample size
Target
30
Accrual to date
7
Final
Recruitment outside Australia
Country [1] 9617 0
Lebanon
State/province [1] 9617 0
Beirut

Funding & Sponsors
Funding source category [1] 298771 0
Self funded/Unfunded
Name [1] 298771 0
Maroun Ghabach
Country [1] 298771 0
Lebanon
Primary sponsor type
Individual
Name
Maroun Ghabach
Address
Rosary Hospital
Departement of Anesthesia
Gemayze
Beirut, Lebanon
Po Box: 175272
Country
Lebanon
Secondary sponsor category [1] 297955 0
None
Name [1] 297955 0
Address [1] 297955 0
Country [1] 297955 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299717 0
Ethics Committee - Rosary Hospital
Ethics committee address [1] 299717 0
Firas Atallah M.D
Chairman of Orthopedic Division
President of Ethics Committee
Rosary Hospital
Gemayze, Beirut.
Ethics committee country [1] 299717 0
Lebanon
Date submitted for ethics approval [1] 299717 0
05/01/2018
Approval date [1] 299717 0
02/02/2018
Ethics approval number [1] 299717 0
001/2018

Summary
Brief summary
Lumbar spine instrumentation surgery is known to cause an intense pain in the postoperative period. The pain can originate from surgery on the different structures such as vertebrae, intervertebral discs, dura , ligaments ,joint capsule fascia , muscles and skin . The posterior sensory rami of the spinal nerves connected to sympathetic and parasympathetic nerves innervate these structures and transmit the pain sensation.
In order to decrease opioids usage and side effects, we propose a method that compare the effect of absorbable gelatin sponge impregnated with local anesthetics versus normal saline placed by the surgeon on the transvers process of the operated vertebra, at the end of the surgery, and before closure of surgical plans, on postoperative visual analogue pain score and the amount of meperidine usage for 48h post-surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63870 0
Dr Maroun Ghabach
Address 63870 0
Maroun ghabach, M.D
Anesthesiologist and Chairman of Anesthesia
Rosary sisters Hospital
Gemayze, Lebanon.
Po Box: 175272
Country 63870 0
Lebanon
Phone 63870 0
+9613451882
Fax 63870 0
+9611447778
Email 63870 0
[email protected]
Contact person for public queries
Name 63871 0
Maroun Ghabach
Address 63871 0
Maroun ghabach, M.D
Anesthesiologist and Chairman of Anesthesia
Rosary sisters Hospital
Gemayze, Lebanon.
Po Box: 175272
Country 63871 0
Lebanon
Phone 63871 0
+9613451882
Fax 63871 0
+9611447778
Email 63871 0
[email protected]
Contact person for scientific queries
Name 63872 0
Maroun Ghabach
Address 63872 0
Maroun ghabach, M.D
Anesthesiologist and Chairman of Anesthesia
Rosary sisters Hospital
Gemayze, Lebanon.
Po Box: 175272
Country 63872 0
Lebanon
Phone 63872 0
+9613451882
Fax 63872 0
+9611447778
Email 63872 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseComparison of Effects of Hemostatic Gelatin Sponge Impregnated with Ropivacaine versus Normal Saline Applied on the Transverse Process of the Operated Vertebrae on Postoperative Pain in Patients Undergoing Spinal Instrumentation Surgery: A Randomized Clinical Trial.2019https://dx.doi.org/10.1016/j.wneu.2019.05.101
N.B. These documents automatically identified may not have been verified by the study sponsor.