RecruitingACTRN12618000768291

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.


Sponsor

Maroun Ghabach

Enrollment

30 participants

Start Date

Feb 9, 2018

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Inclusion Criteria1

  • Patients undergoing spinal intrumentation surgery under general anesthesia.

Exclusion Criteria4

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

Interested in this trial?

Get notified about updates and connect with the research team.

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

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..


Locations(1)

Beirut, Lebanon

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12618000768291