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NCT Number: NCT06965738

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Buccal fat reconstruction

Procedure

Ipsilateral buccal fat rotation flap for reconstruction of lateral oropharyngectomy defect

No buccal fat reconstruction

Procedure

No reconstruction of lateral oropharyngectomy defect

Primary outcomes

  1. 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

    Postoperative pain during rest and swallowing on visual analogue scale at multiple time points

Secondary outcomes

  1. Surgical Complications

    Time frame: 30 days postoperatively

    Surgical complications and adverse events within 30 days postoperatively using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTC-AE v4.0)

  2. Opioid usage

    Time frame: 30 days postoperatively

    Determine opioid usage

  3. Postoperative Hemorrhage

    Time frame: 30 days postoperatively

    Postoperative hemorrhage after TORS

  4. Speech and Swallowing

    Time frame: Once each at the following timepoints: 1-2 week preoperatively, postoperative day 7-10, postoperative day 21-28

    Determine postoperative speech and swallowing using the Performance Status Scale for Head and Neck (PSS-HN)

  5. Oral Diet

    Time frame: Once each at the following timepoints: 1-2 week preoperatively, postoperative day 7-10, postoperative day 21-28

    Determine food consistencies achieved at short post-operative follow up (per PSS-HN)

  6. Feeding Tube Placement

    Time frame: 30 days postoperatively

    Determine rate of feeding tube placement

  7. Blood Glucose

    Time frame: 30 days postoperatively

    Determine blood glucose levels

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Yao, MD FRCSC

CONTACT

[email protected]

(416) 340-3063

Michael Xie, MD FRCSC

CONTACT

[email protected]

(416) 340-3063

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: BOLT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 11, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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