The Effect of Coblation vs Bizact Tonsillectomy on Post-Operative Pain: a randomised control trial

Interventional Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy; Not Applicable Inclusion criteria: Over 18 years of age, able to consent, clinical indications for tonsillectomy as recurrent tonsillitis. Exclusion criteria: History of bleeding disorders, history of general anaesthetic risk, previous peri-tonsillar abscess, tonsillectomy performed due to suspicion of malignancy, contraindications to post-surgical analgesia protocol. tonsillectomy; tonsillectomy;Surgery - Surgical techniques Tonsillectomy is a painful procedure, especially in adults. Recent technological advances have allowed new methods of tonsillectomy to be performed. Radiofrequency Coblation and ultrasonic Bizact methods both claim to improve the patient’s pain post-operatively. Participants will be blinded and randomised to either the Coblation or Bizact tonsillectomy method. These procedures will be performed by highly experienced ENT surgeons. Analgesia will be standardised (Post-surgical analgesia protocol – Tapentadol, Celebrex with oxycodone after tapentadol runs out. Difflam for breakthrough). Both Coblation and Bizact tonsillectomy involve pulling the tonsil away from the pharyngeal wall with forceps. The relevant instrument is then used to separate the tonsil capsule from the pharyngeal constrictor muscles. Both instruments provide simultaneous dissection and haemostasis but can sometimes fail to control bleeding 100%, hence the need for “touch-up” bipolar diathermy in some cases. Normal length of procedure would be estimated to be 5-20 minutes in total. The Evac 70 Coblation wand and Bizact ligasure device are disposable devices, hence needing to be recorded in the operation record and can be checked for adherence to the claimed technique. Pain after tonsillectomy: measured by visual analogue scores [once daily for 14 days post surgery] Bleeding during surgery: measured by volume of blood in suction bottles and weight of swabs[Within the surgical procedure];Bleeding after surgery: measured using Flinders modification of the Stammberger grade for Secondary Post Tonsillectomy Haemorrhage[For period of the 14 days post surgery assessed by the surgeon at the two week follow up appointment ];Duration of surgery: minutes. Recorded by medical staff during the procedure and stored securely with other patient research information. [During the surgical procedure];Days to normal activity: defined as tolerating normal diet, physical activities and return to work/study where appropriate. Assessed through a study specific questionnaire. [Until which time participants can return to normal activity]