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

NCT ID: NCT03071185

Last Updated: 2022-11-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-20
• Study Completion Date: 2022-11-15

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.

Conditions

Elective Reconstructive Surgery; Pain, Post Operative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

femoral nerve block, common peroneal nerve block

Intervention Type: 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.

Group PCA

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group PCA+B+D

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

Group Type: EXPERIMENTAL

femoral nerve block, common peroneal nerve block

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

lower limb blocks with dexmedetomidine as additivewere

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xia Zhang

OTHER

Sponsor Role: lead

Responsible Party

Xia Zhang

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

xia zhang, Ph.D,MD

Role: PRINCIPAL_INVESTIGATOR

School & Hospital of Stomatology, China Medical University, China

Locations

School & Hospital of Stomatology, China Medical University

Shenyang, Liaoning, China

Site Status: RECRUITING

Countries

China

Central Contacts

xia zhang, Ph.D.,MD

Role: CONTACT

zhangxiamd@126.com

8624 31927811

Facility Contacts

xia zhang

Role: primary

Other Identifiers

ChinaMedicalU

Identifier Type: -

Identifier Source: org_study_id