Laryngectomy Clinical Trial
Official title:
Effect of Cervical Epidural Analgesia on the Occurrence of Pharyngocutaneous Fistula Following Salvage Laryngectomy and Reconstruction With Pectoralis Major Myocutaneous Flap
Pharyngocutaneous fistula (PCF) is the most commonly reported postoperative complication in
total laryngectomy patients. PCF significantly increases morbidity, length of
hospitalization, and cost of care, in addition to delaying the beginning of adjuvant therapy.
The reported incidence of PCF ranges from 3% to 65%.The increased use of radiation in the
primary management of laryngeal carcinoma has resulted in an increase in the PCF formation
after salvage laryngectomy (STL).
Previously reported risk factors for PCF development include preoperative radiotherapy, tumor
stage, concomitant neck dissection, prior need for tracheotomy, hypoalbuminemia and anemia.
Among surgical options, the pectoralis major myofascial flap has been proposed to cover the
pharyngeal closure, to interpose non-irradiated tissue between the neopharynx and the skin
during STL. Nonetheless, the efficacy of this approach is not fully established.Epidural
anesthesia improves the blood supply due to its vasodilating effect. The aim of the study is
to evaluate the effect of perioperative cervical epidural analgesia on the occurrence of
pharyngocutaneous fistula following salvage laryngectomy and reconstruction with pectoralis
major myocutaneous flap.
Patients will be divided into two equal groups, group (EP), will receive perioperative
cervical epidural analgesia in addition to general anesthesia and group (GA) will receive
general anesthesia and postoperative analgesia through patient controlled intravenous
morphine analgesia (PCA), that involve 1 mg continuous infusion and 2 mg boluses with lockout
interval 10 min.
Cervical epidural technique: epidural needle will be inserted at C 6-C7 or C7-T1 under
fluoroscopy in prone position, 6 ml of 0.125% bupivacaine and fentanyl 2 mic/ ml will be
administered before skin incision followed by 4 ml of the same injectate, will be infused
continously for 2 days
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