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Local Wound Infiltration for Tracheal Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (Loss of interest in the subject)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

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.


Condition or disease Intervention/treatment Phase
Upper Tracheal Resection Tracheal Reconstruction Surgery Procedure: Superficial cervical plexus block Procedure: Local wound infiltration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Local Wound Infiltration Versus Bilateral Superficial Cervical Plexus Block With Levobupivacaine for Upper Tracheal Resection and Reconstruction Surgery Under General Anesthesia.
Estimated Study Start Date : September 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Superficial cervical plexus block
Patients will receive bilateral superficial cervical plexus block using levobupivacaine
Procedure: Superficial cervical plexus block
Patients will receive bilateral superficial cervical plexus block

Active Comparator: Local wound infiltration
Patients will receive local wound infiltration with levobupivacaine after the conclusion of surgery
Procedure: Local wound infiltration
Patients will receive local wound infiltration




Primary Outcome Measures :
  1. Postoperative pain score [ Time Frame: For 24 hours after surgery ]
    Postoperative pain scores will be assessed using postoperative visual analogue score


Secondary Outcome Measures :
  1. Systolic blood pressure [ Time Frame: For 4 hours after start of surgery ]
  2. Diastolic blood pressure [ Time Frame: For 4 hours after start of surgery ]
  3. Heart rate [ Time Frame: For 4 hours after start of surgery ]
  4. Peripheral oxygen saturation [ Time Frame: For 4 hours after start of surgery ]
  5. End-tidal Carbon dioxide tension [ Time Frame: For 4 hours after start of surgery ]
  6. Bispectral index [ Time Frame: For 4 hours after start of surgery ]
  7. Duration of analgesia [ Time Frame: For 24 hours after surgery ]
    It is defined as time taken for first analgesic request of analgesia from extubation

  8. Cumulative analgesic consumption [ Time Frame: For 24 hours after surgery ]
    total analgesics used for 24 hrs after surgery

  9. Cortisol serum [ Time Frame: before induction ,one hour after start of surgery and one hour after end of surgery ]
    Plasma cortisol assay



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02949661


Sponsors and Collaborators
Mansoura University
Investigators
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Study Chair: Hanaa M Elbendary, MD Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
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Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT02949661    
Other Study ID Numbers: R ∕16.08.18
First Posted: October 31, 2016    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided