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Local Wound Infiltration for Tracheal Reconstruction

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ClinicalTrials.gov Identifier: NCT02949661
Recruitment Status : Withdrawn (Loss of interest in the subject)
First Posted : October 31, 2016
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
Mansoura University

Tracking Information
First Submitted Date  ICMJE October 27, 2016
First Posted Date  ICMJE October 31, 2016
Last Update Posted Date September 11, 2020
Estimated Study Start Date  ICMJE September 2016
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2016)
Postoperative pain score [ Time Frame: For 24 hours after surgery ]
Postoperative pain scores will be assessed using postoperative visual analogue score
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2016)
  • Systolic blood pressure [ Time Frame: For 4 hours after start of surgery ]
  • Diastolic blood pressure [ Time Frame: For 4 hours after start of surgery ]
  • Heart rate [ Time Frame: For 4 hours after start of surgery ]
  • Peripheral oxygen saturation [ Time Frame: For 4 hours after start of surgery ]
  • End-tidal Carbon dioxide tension [ Time Frame: For 4 hours after start of surgery ]
  • Bispectral index [ Time Frame: For 4 hours after start of surgery ]
  • Duration of analgesia [ Time Frame: For 24 hours after surgery ]
    It is defined as time taken for first analgesic request of analgesia from extubation
  • Cumulative analgesic consumption [ Time Frame: For 24 hours after surgery ]
    total analgesics used for 24 hrs after surgery
  • Cortisol serum [ Time Frame: before induction ,one hour after start of surgery and one hour after end of surgery ]
    Plasma cortisol assay
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Local Wound Infiltration for Tracheal Reconstruction
Official Title  ICMJE Local Wound Infiltration Versus Bilateral Superficial Cervical Plexus Block With Levobupivacaine for Upper Tracheal Resection and Reconstruction Surgery Under General Anesthesia.
Brief Summary

Tracheal resection and reconstruction (TRR) is the treatment of choice for most patients with tracheal stenosis or tracheal tumors .The postintubation tracheal stenosis is the common indication for (TRR).The immediate postoperative period can be anxiety provoking for some reasons such as requirement to maintain a flexed neck, oxygen mask, and surgical pain which inadequately treated.

Bilateral superficial cervical plexus block (BSCPB) is a popular regional anesthesia technique for its feasibility and efficacy. The use of regional anesthesia in combination with general anesthesia may lighten the level of general anesthesia required , provide prolonged postoperative analgesia and reduce the requirements for opioid analgesics

Local anesthetic infiltration into the surgical incision can relieve pain at the wound site after surgery, as part of multimodal analgesic approach.

Levobupivacaine, is "S"-enantiomer of bupivacaine, has strongly emerged as a safer alternative for regional anesthesia than bupivacaine . Levobupivacaine has been found to be equally efficacious as bupivacaine, but with a superior pharmacokinetic profile. Clinically, levobupivacaine has been observed to be well tolerated in regional anesthesia techniques both after bolus administration and continuous post-operative infusion.

Detailed Description The aim of this study is to evaluate the intra- and postoperative efficacy of local wound infiltration versus bilateral superficial cervical plexus block with levobupivacaine for upper tracheal resection and reconstruction surgery.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Upper Tracheal Resection
  • Tracheal Reconstruction Surgery
Intervention  ICMJE
  • Procedure: Superficial cervical plexus block
    Patients will receive bilateral superficial cervical plexus block
  • Procedure: Local wound infiltration
    Patients will receive local wound infiltration
Study Arms  ICMJE
  • Experimental: Superficial cervical plexus block
    Patients will receive bilateral superficial cervical plexus block using levobupivacaine
    Intervention: Procedure: Superficial cervical plexus block
  • Active Comparator: Local wound infiltration
    Patients will receive local wound infiltration with levobupivacaine after the conclusion of surgery
    Intervention: Procedure: Local wound infiltration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 9, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2016)
60
Estimated Study Completion Date  ICMJE May 2017
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • American Society of Anesthesiologists physical class status I or II
  • Undergoing elective upper tracheal resection and reconstruction surgery

Exclusion Criteria:

  • Age less than18 years
  • Patients with preoperative medication included opioid
  • History of allergy to the drugs used
  • Coagulation disorders
  • Pregnancy
  • Patient refusal
  • Local sepsis
  • Inability to understand the study protocol or pain scale.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02949661
Other Study ID Numbers  ICMJE R ∕16.08.18
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mansoura University
Study Sponsor  ICMJE Mansoura University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Hanaa M Elbendary, MD Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
PRS Account Mansoura University
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP