Effect of Cervical Epidural Analgesia on the Occurrence of Pharyngocutaneous Fistula

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02870556
• Other study ID #: Not yet assigned
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2016
• Est. completion date: December 10, 2019

Study information

• Verified date: February 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: December 10, 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cutaneous Fistula
• Fistula
• Laryngectomy

Intervention

Device:
• cervical epidural analgesia

Locations

Country	Name	City	State
Egypt	Diab	Assiut	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pharyngocutaneous fistula following salvage laryngectomy and reconstruction with pectoralis major myocutaneous flap		2 weeks postoperatively
Secondary	Pain intensity measured by visual analogue scale (VAS)		0 h (immediately postoperative), 2h, 6h, 12h, 24h, 48h (postoperatively