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

Primary Purpose

Elective Reconstructive Surgery, Pain, Post Operative

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
femoral nerve block, common peroneal nerve block
Sponsored by
Xia Zhang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Elective Reconstructive Surgery focused on measuring free flap, nerve block, elective reconstructive surgery, dexmedetomidine, anterolateral thigh flaps

Eligibility Criteria

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

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.

Sites / Locations

  • School & Hospital of Stomatology, China Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Group PCA+B

Group PCA

Group PCA+B+D

Arm Description

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.

Only intravenous patient controlled analgesia (PCA) was used postoperatively.

Both intravenous PCA and lower limb blocks with dexmedetomidine as additivewere used.

Outcomes

Primary Outcome Measures

Post-operative Narcotic Usage
Total intravenous sulfentanyl usage for rescue analgesia in first 48 hours post-operatively after free fibular flaps and anterolateral thigh flap reconstruction.
duration of sensory blockade
the time of sensory recovery
duration of motor blockade
the time of motor recovery
onset of sensory blockade
the time to sensory blockade
onset of motor blockade
the time to motor blockade

Secondary Outcome Measures

Post-operative Anti-emetic Usage
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.
vital signs
hear rate, blood pressure, SPO2
Post-operative Pain Score
Post-operative Pain Score is defined using Visual Analog Scale (VAS), a patient reported pain score on a scale of 0-10.
adverse effects
such as bradycardia, hypotension,respiratory depression, postoperative sedation

Full Information

First Posted
March 1, 2017
Last Updated
November 21, 2022
Sponsor
Xia Zhang
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1. Study Identification

Unique Protocol Identification Number
NCT03071185
Brief Title
The Efficacy and Safety of Lower Limb Nerve Blocks in Postoperative Analgesia for the Free Flap Donor Sites
Official Title
The Efficacy and Safety of Lower Limb Nerve Blocks in Postoperative Analgesia for the Free Flap Donor Sites
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2017 (Actual)
Primary Completion Date
November 15, 2022 (Anticipated)
Study Completion Date
November 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xia Zhang

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
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. Dexmedetomidine is a more selective and shorter-acting α2 adrenergic receptor. 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. We also investigated the effect of adding dexmedetomidine as additive in femoral nerve blocks for postoperative analgesia. Patients with oromandibular defects who were scheduled for elective reconstructive surgery using free fibular or ALT flaps, were divided into three 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. In Group PCA+B+D, both intravenous PCA and lower limb blocks with dexmedetomidine as additivewere 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.
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 three 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.In Group PCA+B+D, both intravenous PCA and lower limb blocks with dexmedetomidine as additivewere 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elective Reconstructive Surgery, Pain, Post Operative
Keywords
free flap, nerve block, elective reconstructive surgery, dexmedetomidine, anterolateral thigh flaps

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group PCA+B
Arm Type
Experimental
Arm Description
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.
Arm Title
Group PCA
Arm Type
No Intervention
Arm Description
Only intravenous patient controlled analgesia (PCA) was used postoperatively.
Arm Title
Group PCA+B+D
Arm Type
Experimental
Arm Description
Both intravenous PCA and lower limb blocks with dexmedetomidine as additivewere used.
Intervention Type
Procedure
Intervention Name(s)
femoral nerve block, common peroneal nerve block
Other Intervention Name(s)
lower limb blocks with dexmedetomidine as additivewere
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post-operative Narcotic Usage
Description
Total intravenous sulfentanyl usage for rescue analgesia in first 48 hours post-operatively after free fibular flaps and anterolateral thigh flap reconstruction.
Time Frame
48 hours
Title
duration of sensory blockade
Description
the time of sensory recovery
Time Frame
48 hours
Title
duration of motor blockade
Description
the time of motor recovery
Time Frame
48 hours
Title
onset of sensory blockade
Description
the time to sensory blockade
Time Frame
48 hours
Title
onset of motor blockade
Description
the time to motor blockade
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Post-operative Anti-emetic Usage
Description
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.
Time Frame
48 hours
Title
vital signs
Description
hear rate, blood pressure, SPO2
Time Frame
48 hours
Title
Post-operative Pain Score
Description
Post-operative Pain Score is defined using Visual Analog Scale (VAS), a patient reported pain score on a scale of 0-10.
Time Frame
48 hours
Title
adverse effects
Description
such as bradycardia, hypotension,respiratory depression, postoperative sedation
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xia zhang, Ph.D.,MD
Phone
8624 31927811
Email
zhangxiamd@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xia zhang, Ph.D,MD
Organizational Affiliation
School & Hospital of Stomatology, China Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
School & Hospital of Stomatology, China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xia zhang

12. IPD Sharing Statement

Plan to Share IPD
No

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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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