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

NCT03071185 | Unknown

• 1 other identifier: ChinaMedicalU
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Elective Reconstructive Surgery; Pain, Post Operative

Keywords

free flap; nerve block; elective reconstructive surgery; dexmedetomidine; anterolateral thigh flaps

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Post-operative Anti-emetic Usage

  48 hours

• vital signs

  48 hours

• Post-operative Pain Score

  48 hours

• adverse effects

  48 hours

Study Arms (3)

Group PCA+B

EXPERIMENTAL

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

Group PCA

NO INTERVENTION

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

Group PCA+B+D

EXPERIMENTAL

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

Procedure: femoral nerve block, common peroneal nerve block

Interventions

femoral nerve block, common peroneal nerve block PROCEDURE

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.

Also known as: lower limb blocks with dexmedetomidine as additivewere

Group PCA+B; Group PCA+B+D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xia Zhang: lead

Study Sites (1)

School & Hospital of Stomatology, China Medical University

Shenyang, Liaoning, 110002, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• xia zhang, Ph.D,MD

  School & Hospital of Stomatology, China Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xia zhang, Ph.D.,MD

CONTACT

8624 31927811; zhangxiamd@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 6, 2017
• Study Start: January 20, 2017
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2022
• Last Updated: November 25, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)