Postoperative donor site pain in head and neck cancer patients following reconstructive free tissue transfer surgery: A Prospective Observational Study

Introduction:

Microvascular surgery has become a gold standard for reconstruction in head and neck cancers. Radial artery, Antero lateral thigh and Fibula osteo-cutaneous flap are three most popular free flaps for reconstruction following head and neck cancer resections. The goals of reconstructive surgery are to restore appearance and functions like speech, swallowing. The success rate of free flapis more than 95%in majority of centers.

 However, there are certain disadvantages such as mild postoperative deficits and rarelypatients may experience significant donor-site morbidity. Minimizing flap donor site morbidity is equally important.Donor site complications are hematoma, infection, wound dehiscence, sensory loss, pain, gait disturbances, limb weakness, neuroma, seroma, etc. The overall incidence of acute pain in head and neck cancer surgery is high. Pathological cancer staging, surgicalcomplexity, tumor site are associated with increase in severity of pain. In addition treatment, these patients may often be on mild to moderate analgesics for acute pain.Hinther et al,reported high prevalence of chronic postoperative opioid use in patients undergoing head and neck cancer surgery with free flap reconstruction. They identified preoperative opioid use, prior tobacco use, tumor stage, and adjuvant treatment as risk factors for chronic postoperative opioid use.The etiology of postoperative chronic opioid use are complex and multifactorial.Postoperative period isvery crucial forachieving optimal analgesia with minimal side effects but also decreasing the risk of chronic opioid use.

 To the best of our knowledge, there is no literature evaluating impact ofreconstructive surgery and donor site pain on overall incidence of pain in head and neck surgery

Donor site pain can be due to multitude factors such as nerve injury, muscle excision and injury, bone excision causing neuropathic, somatic pain. It may be anadditional source pain, morbidity and quality of life of these patients. However, there is sparse literature evaluating the severity, duration of acute donor site pain associatedmorbidity,use and duration of postoperative opioids and its impact on quality of life.

 Methods and materials:

After IEC and CTRI approval, patients will be screened one day before surgery for enrollment in the study. Informed consent form will be administered in the ward following hospital admission. All patients undergoing head and neck cancer surgery in TMH will be recruited. Perioperative data of patients undergoing elective head and neck cancer surgery will be recorded in the case record form. Patients will be followed until postoperative day (POD)5. Pain score (NRS) at donor site (i.e. flap and skin graft), and surgical site will be recorded once a day. The lowest, and worst pain score both at rest and on movement will be recorded. NRS will be recorded on postoperative day 1, 3, and 5.  Brief Pain Inventory (BPI) and Pain DETECT questionnaire  will be administered at discharge.

 Statistical analysis:

Descriptive data will be expressed as mean or median depending on the distribution of data and to report the results of the questionnaire items. Categorical data will be analyzed using the chi-square test or Fisher Exact test (for binary data). Logistic regression   will   be used for multivariate analysis to find predictive factors associated with NRS score >5.P-value < 0.05 will be considered statistically significant.We will analyse the data at the end of May 2024, for the purpose of thesis.

Ethical considerations:

Patients will be identified by a unique no. and access to study documents will be available only to the investigators and the Institutional Ethics Committee. The trial will be conducted in compliance with the “Ethical Guidelines for Biomedical Research on Human Participants” by the ICMRand ICH-GCP and according to approved study protocol and applicable regulations.