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The Efficacy and Safety of Lower Limb Nerve Blocks in Postoperative Analgesia for the Free Flap Donor Sites

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ClinicalTrials.gov Identifier: NCT03071185
Recruitment Status : Unknown
Verified March 2017 by Xia Zhang, China Medical University, China.
Recruitment status was:  Recruiting
First Posted : March 6, 2017
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Xia Zhang, China Medical University, China

Brief Summary:

The use of free fibular flaps and anterolateral thigh (ALT) flaps for repairing the oromandibular defects is well established, whereas few attentions were focused on postoperative analgesia for the donor area. The purpose of this trial is to determine if using lower limb nerve blocks in patients undergoing free flap-based oromandibular reconstruction can significantly decrease use of pain medications and to evaluate the safety of lower limb nerve blocks.

Patients with oromandibular defects who were scheduled for elective reconstructive surgery using free fibular or ALT flaps, were divided into two groups in a randomized, single-blind fashion. In Group PCA, only intravenous patient controlled analgesia (PCA) was used postoperatively. In Group PCA+B, both intravenous PCA and lower limb blocks were used. Post-operative narcotic usage, post-operative pain score, post-operative anti-emetic usage, vital signs, onset and duration of sensory and motor block, the presence of adverse effects such as nausea and vomiting were recorded.


Condition or disease Intervention/treatment Phase
Elective Reconstructive Surgery Pain, Post Operative Procedure: femoral nerve block, common peroneal nerve block Not Applicable

Detailed Description:

The use of free fibular flaps and anterolateral thigh (ALT) flaps for repairing the oromandibular defects is well established, whereas few attentions were focused on postoperative analgesia for the donor area. Conventional postoperative pain management following oromandibular reconstruction consists of systemic opioids, which can cause nausea, vomiting, pruritus, urinary retention, constipation and respiratory depression. Adequate postoperative analgesia decreases the incidence of cardiopulmonary complications. Peripheral nerve blocks can attenuate the sensory innervations.The purpose of this trial is to determine if using lower limb nerve blocks in patients undergoing free flap-based oromandibular reconstruction can significantly decrease use of pain medications and to evaluate the safety of lower limb nerve blocks.

Patients with oromandibular defects, who were scheduled for elective reconstructive surgery using free fibular or ALT flaps, were divided into two groups in a randomized, single-blind fashion. In Group PCA, only intravenous patient controlled analgesia (PCA) was used postoperatively. In Group PCA+B, both intravenous PCA and lower limb blocks were used. For patients with fibular flaps harvested, femoral nerve block and common peroneal nerve with ropivacaine were administered. For patients with ALT flaps harvested, femoral nerve block with ropivacaine was administered. Post-operative narcotic usage, post-operative pain score, post-operative anti-emetic usage, vital signs, onset and duration of sensory and motor block, the presence of adverse effects such as nausea and vomiting were recorded.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Efficacy and Safety of Lower Limb Nerve Blocks in Postoperative Analgesia for the Free Flap Donor Sites
Actual Study Start Date : January 20, 2017
Estimated Primary Completion Date : April 30, 2017
Estimated Study Completion Date : April 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group PCA+B
Both intravenous PCA and lower limb blocks were used. For patients with fibular flaps harvested, femoral nerve block and common peroneal nerve block with ropivacaine were administered. For patients with ALT flaps harvested, femoral nerve block with ropivacaine was administered.The interventions are femoral nerve block, common peroneal nerve block.
Procedure: femoral nerve block, common peroneal nerve block
For patients with fibular flaps harvested, femoral nerve block and common peroneal nerve with ropivacaine were administered. For patients with ALT flaps harvested, femoral nerve block with ropivacaine was administered.

No Intervention: Group PCA
Only intravenous patient controlled analgesia (PCA) was used postoperatively.



Primary Outcome Measures :
  1. Post-operative Narcotic Usage [ Time Frame: 48 hours ]
    Total intravenous sulfentanyl usage for rescue analgesia in first 48 hours post-operatively after free fibular flaps and anterolateral thigh flap reconstruction.


Secondary Outcome Measures :
  1. Post-operative Anti-emetic Usage [ Time Frame: 48 hours ]
    Post-operative Anti-emetic Usage is defined as the total amount of IV tropisetron administered to a patient during the first 48 hours post-operatively.

  2. vital signs [ Time Frame: 48 hours ]
    hear rate, blood pressure, SPO2

  3. Post-operative Pain Score [ Time Frame: 48 hours ]
    Post-operative Pain Score is defined using Visual Analog Scale (VAS), a patient reported pain score on a scale of 0-10.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prior diagnosis or presumed diagnosis of oral and maxillofacial tumor.
  • Undergoing microsurgical oromandibular reconstruction with free fibular flaps and anterolateral thigh flaps.
  • Greater than 18 years old.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • True allergy to local anesthetics or opioids.
  • History of addiction to narcotics within the last 24 months
  • History of chronic pain on opioids within the last 24 months.
  • Specific mental health issues such as schizophrenia or bipolar disorder.
  • Patients who are pregnant.

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): NCT03071185


Contacts
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Contact: xia zhang, Ph.D.,MD 8624 31927811 zhangxiamd@126.com

Locations
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China, Liaoning
School & Hospital of Stomatology, China Medical University Recruiting
Shenyang, Liaoning, China, 110002
Contact: xia zhang         
Sponsors and Collaborators
Xia Zhang
Investigators
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Principal Investigator: xia zhang, Ph.D,MD School & Hospital of Stomatology, China Medical University, China
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Responsible Party: Xia Zhang, Associate Professor, China Medical University, China
ClinicalTrials.gov Identifier: NCT03071185    
Other Study ID Numbers: ChinaMedicalU
First Posted: March 6, 2017    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xia Zhang, China Medical University, China:
free flap
nerve block
elective reconstructive surgery
free fibular
anterolateral thigh flaps
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations