Effect of Cervical Epidural Analgesia on the Occurrence of Pharyngocutaneous Fistula

Not Applicable

• Conditions: Laryngectomy; Cutaneous Fistula
• Interventions: Device: cervical epidural analgesia

• Registration Number: NCT02870556
• Lead Sponsor: Assiut University

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

Study Timeline

• Study First Submitted: 2016-08-12
• Study First Submitted QC: 2016-08-12
• Study First Posted: 2016-08-17
• Study Start: 2016-12-20
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-07
• Last Update Posted: 2019-02-11
• Primary Completion: 2019-11
• Study Completion: 2019-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GA, General anesthesia	cervical epidural analgesia	patients undergoing salvage laryngectomy (failed radiotherapy to treat laryngeal cancer) will receive standard general anesthesia only (induction with propofol 2 mg / kg, endotracheal intubation facilitated by cis-atracurium 0.3 mg / kg and 0.15 mg /kg on demand and maintained with inhalational anesthetic sevoflurane) in addition to postoperative analgesia through patient controlled intravenous morphine analgesia (PCA), that involve 1 mg continuous infusion and 2 mg boluses with lockout interval 10 min
EP, Cervical epidural group	cervical epidural analgesia	patients undergoing salvage laryngectomy (failed radiotherapy to treat laryngeal cancer) will receive cervical epidural analgesia in addition to the standard general anesthesia (induction with propofol 2 mg / kg, endotracheal intubation facilitated by cis-atracurium 0.3 mg / kg and 0.15 mg /kg on demand and maintained with inhalational anesthetic sevoflurane) 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

Primary Outcome Measures

Name	Time	Method
pharyngocutaneous fistula following salvage laryngectomy and reconstruction with pectoralis major myocutaneous flap	2 weeks postoperatively

Secondary Outcome Measures

Name	Time	Method
Pain intensity measured by visual analogue scale (VAS)	0 h (immediately postoperative), 2h, 6h, 12h, 24h, 48h (postoperatively

Trial Locations

Locations (1)

Diab; 🇪🇬 Assiut, Assuit, Egypt