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Effect of Cervical Epidural Analgesia on the Occurrence of Pharyngocutaneous Fistula

Primary Purpose

Cutaneous Fistula, Laryngectomy

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
cervical epidural analgesia
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cutaneous Fistula focused on measuring cervical epidural, laryngectomy, pharyngocutaneous fistula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • DiabRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EP, Cervical epidural group

GA, General anesthesia

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain intensity measured by visual analogue scale (VAS)

Full Information

First Posted
August 12, 2016
Last Updated
February 7, 2019
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02870556
Brief Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 20, 2016 (Actual)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
December 10, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Fistula, Laryngectomy
Keywords
cervical epidural, laryngectomy, pharyngocutaneous fistula

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EP, Cervical epidural group
Arm Type
Experimental
Arm Description
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
Arm Title
GA, General anesthesia
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
cervical epidural analgesia
Primary Outcome Measure Information:
Title
pharyngocutaneous fistula following salvage laryngectomy and reconstruction with pectoralis major myocutaneous flap
Time Frame
2 weeks postoperatively
Secondary Outcome Measure Information:
Title
Pain intensity measured by visual analogue scale (VAS)
Time Frame
0 h (immediately postoperative), 2h, 6h, 12h, 24h, 48h (postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who failed treatment with radiotherapy for laryngeal cancer Exclusion Criteria: Infection at the site of flap Primary laryngectomy without radiotheraapy
Facility Information:
Facility Name
Diab
City
Assiut
State/Province
Assuit
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diab Hetta, MD
Phone
+201091090009

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Cervical Epidural Analgesia on the Occurrence of Pharyngocutaneous Fistula

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