Efficacy and Safety of Sodium Hyaluronate with 1,4-Butanediol Diglycidyl Ether Compared to Sodium Carboxymethylcellulose in Preventing Adhesion Formation after Lumbar Discectomy.
10.14245/kjs.2015.12.2.41
- Author:
Gyu Yeul JI
1
;
Chang Hyun OH
;
Byung Gwan MOON
;
Seong YI
;
In Bo HAN
;
Dong Hwa HEO
;
Ki Tack KIM
;
Dong Ah SHIN
;
Keung Nyun KIM
Author Information
1. Department of Neurosurgery, Yonsei University College of Medicine, Seoul, Korea. shindongah@me.com
- Publication Type:Clinical Trial ; Controlled Clinical Trial ; Multicenter Study ; Randomized Controlled Trial ; Original Article
- Keywords:
Anti-adhesion;
Scar formation;
Lumbar discectomy;
Sodium hyaluronate;
1,4-butanediol diglycidyl ether (BDDE);
Sodium carboxymethylcellulose (CMC)
- MeSH:
Carboxymethylcellulose Sodium*;
Cicatrix;
Diskectomy*;
Ether*;
Gels;
Hyaluronic Acid*;
Hyaluronoglucosaminidase;
Injections, Epidural;
Leg;
Spine
- From:Korean Journal of Spine
2015;12(2):41-47
- CountryRepublic of Korea
- Language:English
-
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.
