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

Plain Language Summary

Simplified for easier understanding

Back surgery involving spinal hardware (instrumentation) — such as screws, rods, and cages — is known to cause significant pain in the days after the operation. Managing this pain well is important not just for comfort, but to help patients breathe deeply, move, and recover more quickly. This study is testing whether placing an absorbable gelatin sponge soaked in the local anaesthetic ropivacaine on the bony parts of the spine (the transverse processes) at the end of surgery can reduce pain and the need for strong opioid painkillers afterward. Participants will be randomly assigned to receive either the ropivacaine-soaked sponge or an identical sponge soaked in plain saline (the placebo), with neither the patient nor the care team knowing which was used. Pain scores and opioid use will be tracked for 48 hours after surgery. You may be eligible if you are between 18 and 75 years old and scheduled to undergo spinal instrumentation surgery under general anaesthesia. People who have had previous spinal surgery at the same level, are having surgery for a spinal tumour, or have an allergy to local anaesthetics are not eligible. This study is being conducted in Lebanon and offers a safe, non-invasive approach to potentially improving post-operative pain management.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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ACTRN12618000768291