Effect of Cervical Epidural Analgesia on the Occurrence of Pharyngocutaneous Fistula

NCT02870556 | Unknown

• 1 other identifier: Not yet assigned
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Fistula; Laryngectomy

Keywords

cervical epidural, laryngectomy, pharyngocutaneous fistula

Outcome Measures

Primary Outcomes (1)

• pharyngocutaneous fistula following salvage laryngectomy and reconstruction with pectoralis major myocutaneous flap

  2 weeks postoperatively

Secondary Outcomes (1)

• Pain intensity measured by visual analogue scale (VAS)

  0 h (immediately postoperative), 2h, 6h, 12h, 24h, 48h (postoperatively

Study Arms (2)

EP, Cervical epidural group

EXPERIMENTAL

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

Device: cervical epidural analgesia

GA, General anesthesia

ACTIVE COMPARATOR

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

Device: cervical epidural analgesia

Interventions

cervical epidural analgesia DEVICE

EP, Cervical epidural group; GA, General anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who failed treatment with radiotherapy for laryngeal cancer

You may not qualify if:

• Infection at the site of flap
• Primary laryngectomy without radiotheraapy

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Diab

Asyut, Assuit, 71515, Egypt

RECRUITING

MeSH Terms

Conditions

Cutaneous Fistula

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: August 17, 2016
• Study Start: December 20, 2016
• Primary Completion: November 1, 2019
• Study Completion: December 10, 2019
• Last Updated: February 11, 2019

Record last verified: 2019-02

Locations

EG (1)