Buccal Fat for Transoral Robotic Lateral Oropharyngectomy Defects to and Postoperative Pain

Official title

Buccal Fat Applied to Transoral Robotic Lateral Oropharyngectomy Defects to Lessen Radical Tonsillectomy Pain (BOLT)

Overview

The goal of this randomized clinical trial is to determine the pain intensity during rest and swallowing in patients undergoing transoral robotic surgery for tonsil lesions with and without buccal fat reconstruction. The main question it aims to answer is: does buccal fat after transoral robotic surgery reduce pain after surgery? Additional questions to be explored include if there is a difference in swallowing, complication rates, pain medication usage, and feeding tube usage. Participants will be asked to rate their pain and swallowing on a visual analogue scale after surgery. The group will be compared compared to a control group that undergoes transoral robotic surgery without buccal fat reconstruction.

Detailed description

Trans-oral robotic surgery (TORS) for oropharyngeal cancers have transformed how oropharyngeal cancers are managed, allowing for minimally invasive surgical access to remove tumors of the tonsil and base of tongue. While large incisions and open approaches can be avoided, oropharyngeal defects following TORS are traditionally left as an open wound to heal by secondary intention, resulting in significant postoperative pain, and possibly dysphagia and dehydration.

While this has been highlighted as a key outcome measure, studies on acute pain following TORS have not had any standardization regarding the timing of pain measurement, and pain assessment. Only one study has assessed pain during 'movement-related pain', such as swallowing, which has been advocated as a key metric. Most studies used a visual analogue scale, however, majority failed to describe the timing of pain assessment relative to administration of analgesia, time of day, or diet. Overall, pain ratings and opioid utilization were highly variable between studies resulting in pain ratings ranging widely from 2.5-8 in the first few days postoperatively.

Based on the current evidence, multimodal analgesia resulted in the lowest pain ratings following TORS, with those that included gabapentin, a COX-2 inhibitor and acetaminophen having excellent pain control in the early postoperative period. Using these regimens, Castellanos et al. found that postoperative opioid consumption significantly decreased in the first three postoperative days. Clayburgh, et al. identified that addition of perioperative corticosteroids was safe and significantly improved diet consistency, and decreased length of hospital stay, though pain scores were minimally affected.

No study thus far has assessed the impact of surgical interventions on postoperative pain and swallowing. This single center, phase II, randomized control trial aims to evaluate the impact of the buccal fat rotational flap on the postoperative pain following TORS.

Interventions

• Procedure Buccal fat reconstruction
  Ipsilateral buccal fat rotation flap for reconstruction of lateral oropharyngectomy defect
• Procedure No buccal fat reconstruction
  No reconstruction of lateral oropharyngectomy defect

Primary outcome measures

• Postoperative pain during rest and swallowing [Time frame: Once each at the following timepoints: 1-2 week preoperatively, postoperative day 1-3, postoperative day 7-10, postoperative day 21-28]

Secondary outcome measures (7)

• Surgical Complications [Time frame: 30 days postoperatively]
• Opioid usage [Time frame: 30 days postoperatively]
• Postoperative Hemorrhage [Time frame: 30 days postoperatively]
• Speech and Swallowing [Time frame: Once each at the following timepoints: 1-2 week preoperatively, postoperative day 7-10, postoperative day 21-28]
• Oral Diet [Time frame: Once each at the following timepoints: 1-2 week preoperatively, postoperative day 7-10, postoperative day 21-28]
• Feeding Tube Placement [Time frame: 30 days postoperatively]
• Blood Glucose [Time frame: 30 days postoperatively]

Eligibility criteria

Inclusion criteria

• Age > 18
• Require a transoral robotic lateral oropharyngectomy as a result of the following conditions :

• Early - intermediate stage tonsillar squamous cell carcinoma (T1-2N0-1 p16+/- SCC of the palatine tonsils)
• Early -intermediate stage salivary gland tumors of the palatine tonsils
• based on FNA, Core biopsy, Punch biopsy
• Ability to understand and willing to sign a written informed consent

Exclusion criteria

• History of prior head and neck squamous cell carcinoma, or prior head and neck radiotherapy
• Presence of retropharyngeal lymphadenopathy
• Presence of bilateral lymphadenopathy, or patients requiring bilateral neck dissections.
• Patients with trismus at baseline
• Patients with psychological risk factors for persistent opioid use or drug addiction
• Need for open surgery (transcervical lateral oropharyngectomy), free tissue transfer, or alternative regional flap.
• Pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

• Toronto General Hospital — Toronto

Publications

• Xie M, de Almeida J, Goldstein D, Martino R, Liu YF, Allen B, Xu W, Hueniken K, Yao CM. Buccal fat applied to transoral robotic lateral oropharyngectomy defects to lessen radical tonsillectomy pain (BOLT): a single-centre, phase II, parallel, randomised control trial study protocol. BMJ Open. 2025 Dec 12;15(12):e106125. doi: 10.1136/bmjopen-2025-106125. PMID 41387003

Identifiers

NCT: NCT06965738 · 24-5894

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗