None listed
Conditions
Brief summary
Trial Objective - To determine the efficacy of the ultrasound guided “hamstrings block” in reducing pain and enhancing quality of recovery following anterior cruciate ligament reconstruction (ACLR) with a hamstring autograft. By doing this study we hope to show that the “Hamstrings block” is effective and provide clinical evidence to support the use of this nerve block in order to optimise recovery and improve patient outcomes in the future. Patients will be randomised to one of two groups. The first group will receive the current standard anaesthetic for ACLRs. The other group will receive the current standard anaesthetic for ACLRs plus the novel “hamstrings block”. This will be performed under general anaesthesia. Post-operatively routine questions will be asked about pain levels and any side effects. We will briefly examine the leg to look for effects of the block by testing sensation and muscle strength. Pain levels and presence of nausea/vomiting will be recorded immediately after the operation, at 1 hour, at 6 hours and 24 hours. Also, before and after the operation we will be asking patients to complete a standardised questionnaire that will help us judge how patients have found the recovery following the operation. We then plan to analyse the results and do a Peer reviewed publication of these results in approximately 12 months time.
Interventions
Does the addition of ultrasound guided hamstrings block result in improved post-op analgesia compared to adductor canal block alone after autologous hamstring graft ACL reconstruction.
Patients will be given an information sheet and consent form outlining the purpose of the study, what the study involves and commonly asked questions.
Induction of anaesthesia will be performed with 1-2mcg/kg of fentanyl and propofol titrated to effect. Anaesthesia will be maintained with sevoflurane in air: oxyg
Does the addition of ultrasound guided hamstrings block result in improved post-op analgesia compared to adductor canal block alone after autologous hamstring graft ACL reconstruction. Patients will be given an information sheet and consent form outlining the purpose of the study, what the study involves and commonly asked questions. Induction of anaesthesia will be performed with 1-2mcg/kg of fentanyl and propofol titrated to effect. Anaesthesia will be maintained with sevoflurane in air: oxygen to achieve an age adjusted MAC (minimum alveolar concentration) of 1.0. An Fi02 of 0.5 will be administered and ventilation managed to achieve tidal volumes of 7-10ml/kg prior to the establishment of spontaneous ventilation. Ventilation will be either spontaneous or pressure supported and fentanyl will be titrated to achieve a respiratory rate of 10-16/min. Once general anaesthesia has been established the nerve blocks will be preformed. Intervention blocks: o Standard Care Plus Hamstring block – in addition to adductor canal block a hamstring block will also be performed via ultrasound guidance using the same 100mm 22g Stimuplex needle to inject: 20ml 0.2% Ropivacaine (40mg Ropivacaine) with placed posterior to the belly of gracilis at the level of the adductor canal (mid-thigh) 20ml 0.2% Ropivacaine (40mg Ropivacaine) is placed either side of semitendinosus in the mid-thigh Blocks will be performed by consultant anaesthetists or regional anaesthesia fellows under direct supervision. Blocks will be preformed around the Saphaneous nerve in the adductor canal and hamstring fascial planes via ultrasound guidance. Blocks wil be preformed once only after general anaesthesia has been established in the operating theatre.
Sponsors
Dr Hamish Mace
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria 1. Patients undergoing ACL reconstruction with ipsilateral hamstrings graft 2. Age between 18 and 65 3. Operation performed under general anaesthesia
Exclusion criteria
Exclusion criteria 1. Patients having ACLR without hamstrings graft a. ACL reconstruction using unilateral or contralateral patellar / quadriceps tendon grafts b. ACL reconstruction using allogenic (deceased donor) grafts c. ACL reconstruction with multi-ligament repair 2. Contralateral graft harvest site 3. Revision surgery 4. Allergy to amide local anaesthetic or its constituents 5. Allergy or contraindication to the administration of the adjuvant analgesic agents 6. Chronic pre-operative opioid use (>30mg oral morphine equivalent daily) 7. Hepatic or renal insufficiency 8. Patients unable or unwilling to give consent 9. Pregnancy 10. Spinal anaesthesia 11. Intra operative fentanyl dose greater than 4 mcg/kg 12. Pre-operative analgesia 13. Use of intraoperative nitrous oxide 14. Use of surgical instilled local anaesthetic into the hamstring donor site
Outcome results
None listed