Clinical trial NCT02870556: Effect of Cervical Epidural Analgesia on the Occurrence of Pharyngocutaneous Fistula
Official title: Effect of Cervical Epidural Analgesia on the Occurrence of Pharyngocutaneous Fistula Following Salvage Laryngectomy and Reconstruction With Pectoralis Major Myocutaneous Flap
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cutaneous Fistula
Laryngectomy
Keywords: cervical epidural, laryngectomy, pharyngocutaneous fistula
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Patients who failed treatment with radiotherapy for laryngeal cancer

Exclusion Criteria:

1. Infection at the site of flap
2. Primary laryngectomy without radiotheraapy

Primary outcomes:
measure: pharyngocutaneous fistula following salvage laryngectomy and reconstruction with pectoralis major myocutaneous flap
timeFrame: 2 weeks postoperatively
Secondary outcomes:
measure: Pain intensity measured by visual analogue scale (VAS)
timeFrame: 0 h (immediately postoperative), 2h, 6h, 12h, 24h, 48h (postoperatively
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Diab
state: Assuit
Study officials:
References: