Clinical trial NCT06965738: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Tonsil Neoplasm
Oropharynx Neoplasm
Transoral Robotic Surgery
Keywords: Transoral Robotic Surgery
Buccal Fat
Postoperative Pain
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Age \> 18
2. 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
3. Ability to understand and willing to sign a written informed consent

Exclusion Criteria:

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

Primary outcomes:
measure: Postoperative pain during rest and swallowing
timeFrame: Once each at the following timepoints: 1-2 week preoperatively, postoperative day 1-3, postoperative day 7-10, postoperative day 21-28
Secondary outcomes:
measure: Surgical Complications
timeFrame: 30 days postoperatively
measure: Opioid usage
timeFrame: 30 days postoperatively
measure: Postoperative Hemorrhage
timeFrame: 30 days postoperatively
measure: Speech and Swallowing
timeFrame: Once each at the following timepoints: 1-2 week preoperatively, postoperative day 7-10, postoperative day 21-28
measure: Oral Diet
timeFrame: Once each at the following timepoints: 1-2 week preoperatively, postoperative day 7-10, postoperative day 21-28
measure: Feeding Tube Placement
timeFrame: 30 days postoperatively
measure: Blood Glucose
timeFrame: 30 days postoperatively
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Christopher Yao, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: John R de Almeida, MD MSc FRCSC
role: STUDY_DIRECTOR
affiliation: University Health Network, Toronto
name: Michael Xie, MD FRCSC
role: STUDY_CHAIR
affiliation: University Health Network, Toronto
name: Rosemary Martino, Ma MSc PhD
role: STUDY_CHAIR
References: