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.

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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618000768291

Enrollment

Registered

2018-05-07

Start date

2018-02-09

Completion date

2018-05-22

Last updated

2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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..

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Patients undergoing spinal intrumentation surgery under general anesthesia.

Exclusion criteria

:Previous spinal surgery, Spinal tumor surgery, Refusal of the patient. History of allergy to local anesthetic..

Outcome results