Safety and efficacy of extended‐release bupivacaine local anaesthetic in open hernia repair: a randomized controlled trial

Hadj, Afif; Hadj, Andrew K; Hadj, Anthony; Rosenfeldt, Franklin; Nicholson, Douglas; Moodie, John; Turner, Richard M.; Watts, Richard W.; Fletcher, Ian R.; Abrouk, Nacer; Lissin, Dmitri

doi:10.1111/j.1445-2197.2011.05754.x

Cited by 36 publications

(27 citation statements)

References 11 publications

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“…(Im and Tae, 2005). In another study, the risk of septic knee after retrograde intramedullary femoral nailing was four times greater in open fractures than closed fractures (Halvorson et al, 2012). In a trial comparing recombinant human bone morphogenetic protein-2 (rhBMP-2)/collagen sponge treatment with the standard of care treatment in open tibial fractures, the rhBMP-2 treated group showed a significant increase in infections (Aro et al, 2011).…”

Section: Introductionmentioning

confidence: 99%

“…A water-free tricalcium phosphate formulation was found to induce ectopic bone formation in a canine muscle pouch model (Davison et al, 2012). SAIB also uses water-free carriers and has been reported to support a range of alternative solvents including benzyl alcohol (Hadj et al, 2009), ethanol, ethyl lactate and N-methyl-2-pyrrolidone (Lu et al, 2007). Some organic solvents can be poorly tolerated and may cause pain at the injection site (Packhaeuser et al, 2004), making solvent selection a key consideration.…”

Section: Tl Cheng Et Al Saib For Bone Tissue-engineeringmentioning

confidence: 99%

“…SAIB is currently being trialled for sustained delivery of Risperidone to schizophrenia patients (clinicaltrials.gov NCT01592110) (Lu et al, 2007). Trials for the treatment of pain (particularly associated with hernia) with bupivacaine via SAIB have been recently completed (clinicaltrials.gov NCT01052012, NCT00974350) with no safety issues reported (Hadj et al, 2012). The intramuscular delivery of SAIB has seen to be well tolerated in animal models.…”

Section: Introductionmentioning

confidence: 99%

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A sugar-based phase-transitioning delivery system for bone tissue engineering

Cheng

Valtchev²,

Murphy³

et al. 2013

eCM

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Bone tissue engineering approaches commonly involve the delivery of recombinant human bone morphogenetic proteins (rhBMPs). However, there are limitations associated with the currently used carriers, including the need for surgical implantation and the associated increase in infection risk. As an alternative to traditional porous collagen sponge, we have adopted a solution of the injectable sucrose acetate isobutyrate (SAIB) as a carrier for rhBMP-2. The ability to deliver rhBMP-2 and other agents by injection reduces the infection risk and lesion size whilst in surgery, with the potential to avoid open surgery altogether in some indications.The primary methodology used for this in vivo study was a C57BL6/J mouse ectopic bone formation model. Specimens were examined by x-ray, microCT, and histology at 3 weeks. SAIB was delivered non-invasively and produced up to 3-fold greater bone volume compared to collagen. To further refine and improve upon the formulation, SAIB containing rhBMP-2 was admixed with candidate compounds including ceramic microparticles, antiresorptives, and cell signalling inhibitors and further tested in vivo. The formulation combining SAIB/rhBMP-2, the bisphosphonate zoledronic acid (ZA), and hydroxyapatite (HA) microparticles yielded a 10-fold greater bone volume than SAIB/rhBMP-2 alone. To investigate the mechanism underlying the synergy between ZA and HA, we used in vitro binding assays and in vivo fluorescent biodistribution studies to demonstrate that ceramic particles could bind and sequester the bisphosphonate. These data show the utility of SAIB as a non-invasive rhBMP delivery system as well as describing an optimised formulation for bone tissue engineering. (Im and Tae, 2005). In another study, the risk of septic knee after retrograde intramedullary femoral nailing was four times greater in open fractures than closed fractures (Halvorson et al., 2012). In a trial comparing recombinant human bone morphogenetic protein-2 (rhBMP-2)/collagen sponge treatment with the standard of care treatment in open tibial fractures, the rhBMP-2 treated group showed a significant increase in infections (Aro et al., 2011). Thus the development of a system able to deliver rhBMPs percutaneously to an orthopaedic site could reduce lesion size and minimise infection risk. KeywordsAlthough various polymeric materials, such as degradable hydrogels, have been developed by many groups to serve as injectable scaffolds (Miyamoto and Takaoka, 1993;Han and Hubbell, 1996;Burdick and Anseth, 2002;Lutolf et al., 2003), progression towards clinical application has been limited. However, we have chosen a material called sucrose acetate isobutyrate (SAIB), a sugar-based ester that is currently used as a food additive (emulsifier E444), as well as in cosmetics and industrial processes. In the United States, SAIB is approved by the Food and Drug Administration as a food additive, and has an allowable daily intake of 20 mg/kg/ day (21 CFR 172.833; 64 Fed. Reg. 29949, 4 June 1999). It has been considered safe for u...

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Section: Introductionmentioning

confidence: 99%

Section: Tl Cheng Et Al Saib For Bone Tissue-engineeringmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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A sugar-based phase-transitioning delivery system for bone tissue engineering

Cheng

Valtchev²,

Murphy³

et al. 2013

eCM

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“…In a multicentre randomized controlled trial on open inguinal hernia repair, a 5 mL dose of SABER-Bupivacaine locally administered at the surgical site significantly reduced acute postoperative pain compared with placebo and reduced supplemental opioid consumption by 26% (although this was not significant). 100 …”

Section: Sabermentioning

confidence: 99%

Optimizing pain management to facilitate Enhanced Recovery After Surgery pathways

Tan

Law

Gan

2014

Can J Anesth/J Can Anesth

288

206

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“…52 Furthermore, liposomal bupivacaine can provide up to 72 hours of local pain relief and has proven safety and efficacy. 53 A study of liposomal bupivacaine injection performed as a regional block in abdominoplasty with rectus plication found that patients experienced reduced postoperative pain, required less postoperative narcotic medication, and resumed both earlier ambulation and normal activity compared to controls.…”

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confidence: 99%

Ambulatory anesthesia in plastic surgery: opportunities and challenges

Facque¹,

Taub²

2015

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Abstract:In 2013, there were 17 million procedures performed by plastic and reconstructive surgeons in the United States in the private office or ambulatory "surgicenter" setting, as well as additional operations performed in hospitals on an outpatient basis. As interest in performing increasingly complex surgical procedures on an outpatient basis continues to grow, the surgeon and anesthesiologist alike must be prepared to offer safe and reliable anesthesia and analgesia in the ambulatory setting. Surgeons must be aware of the possible techniques that will be employed in their surgeries in order to anticipate and prepare patients for possible postoperative side effects, and anesthesiologists must be prepared to offer such techniques in order to ensure a relatively rapid return to normal activity despite potentially having undergone major surgery. The following is a review of the specific considerations that should be given to ambulatory plastic surgery patients with comments on recent developments in the techniques used to safely administer agreeable and effective anesthesia.

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Safety and efficacy of extended‐release bupivacaine local anaesthetic in open hernia repair: a randomized controlled trial

Abstract: After open inguinal hernia repair, SABER-Bupivacaine administered at the surgical site was safe and provided pain relief, reduced the need for supplemental (oral and parenteral) analgesia and did not impair wound healing.

Cited by 36 publications

References 11 publications

A sugar-based phase-transitioning delivery system for bone tissue engineering

A sugar-based phase-transitioning delivery system for bone tissue engineering

Optimizing pain management to facilitate Enhanced Recovery After Surgery pathways

Ambulatory anesthesia in plastic surgery: opportunities and challenges

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