Korean J Spine.
2015 Jun;12(2):41-47. 10.14245/kjs.2015.12.2.41.
Efficacy and Safety of Sodium Hyaluronate with 1,4-Butanediol Diglycidyl Ether Compared to Sodium Carboxymethylcellulose in Preventing Adhesion Formation after Lumbar Discectomy
- Affiliations
-
- 1Department of Neurosurgery, Yonsei University College of Medicine, Seoul, Korea. shindongah@me.com
- 2Department of Neurosurgery, Guro Teun Teun Hospital, Seoul, Korea.
- 3Department of Neurosurgery, Eulji Hospital, Eulji University College of Medicine, Seoul, Korea.
- 4Department of Neurosurgery, Bundang CHA Medical Center, CHA University College of Medicine, Sungnam, Korea.
- 5Department of Neurosurgery, The Leon Wiltse Memorial Hospital, Suwon, Korea.
- 6Department of Orthopedic Surgery, Kyung Hee University College of Medicine, Seoul, Korea.
- KMID: 1927557
- DOI: http://doi.org/10.14245/kjs.2015.12.2.41
Abstract
OBJECTIVE
Epidural injection of hyaluronic acid may prevent adhesion formation after spine surgery, but the compounds used to stabilize hyaluronidase could interfere with its anti-adhesion effects. The present study was conducted as a clinical trial to evaluate the efficacy and safety of an experimental medical gel in preventing adhesion formation.
METHODS
This study was designed as a multicenter, randomized, double-blind, and comparative controlled clinical trial with an observation period of 6 weeks. Subjects were randomly assigned into two groups: group A with sodium hyaluronate + 1,4-butanediol diglycidyl ether (BDDE) and group B with sodium hyaluronate + sodium carboxymethylcellulose (CMC). Visual analogue scale (VAS) of back and leg pain and the Oswestry disability index (ODI) and scar score ratings were assessed after surgery.
RESULTS
Mean scar grade was 2.37+/-1.13 in group A and 2.75+/-0.97 in group B, a statistically significant difference (p=0.012). VAS of back and leg pain and ODI scores decreased significantly from baseline to 3 and 6 weeks postoperatively in both groups (p<0.001). However, VAS and ODI scores were not statistically different between groups A and B at baseline or at 3 and 6 weeks after operation (p>0.3). The number of adverse reactions related to the anti-adhesion gels was not statistically different (p=0.569), but subsequent analysis of nervous adverse reactions showed group B was superior with a statistically difference (p=0.027).
CONCLUSION
Sodium hyaluronate with BDDE demonstrated similar anti-adhesion properties to sodium hyaluronate with CMC. But, care should be used to nervous adverse reactions by using sodium hyaluronate with BDDE.
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