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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Post Operative; Elective Reconstructive Surgery
• Intervention / Treatment: Procedure: femoral nerve block, common peroneal nerve block

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: xia zhang, Ph.D.,MD; Phone Number: 8624 31927811; Email: zhangxiamd@126.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110002
      • Recruiting
      • School & Hospital of Stomatology, China Medical University
      • Contact: Xia Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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.; Other Names: lower limb blocks with dexmedetomidine as additivewere
NO_INTERVENTION: Group PCA; Only intravenous patient controlled analgesia (PCA) was used postoperatively.
EXPERIMENTAL: Group PCA+B+D; Both intravenous PCA and lower limb blocks with dexmedetomidine as additivewere used.	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.; Other Names: lower limb blocks with dexmedetomidine as additivewere

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48 hours
duration of sensory blockade	the time of sensory recovery	48 hours
duration of motor blockade	the time of motor recovery	48 hours
onset of sensory blockade	the time to sensory blockade	48 hours
onset of motor blockade	the time to motor blockade	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48 hours
vital signs	hear rate, blood pressure, SPO2	48 hours
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.	48 hours
adverse effects	such as bradycardia, hypotension,respiratory depression, postoperative sedation	48 hours

Collaborators and Investigators

• Sponsor: Xia Zhang
• Investigators: Principal Investigator: xia zhang, Ph.D,MD, School & Hospital of Stomatology, China Medical University, China

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 20, 2017
• Primary Completion (ANTICIPATED): November 15, 2022
• Study Completion (ANTICIPATED): November 15, 2022

Study Registration Dates

• First Submitted: March 1, 2017
• First Submitted That Met QC Criteria: March 3, 2017
• First Posted (ACTUAL): March 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 25, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: dexmedetomidine; nerve block; free flap; elective reconstructive surgery; anterolateral thigh flaps
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: ChinaMedicalU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No