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

Pain, Post Operative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03071185
• Other study ID #: ChinaMedicalU
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2017
• Est. completion date: November 15, 2022

Study information

• Verified date: November 2022
• Source: China Medical University, China
• Contact: xia zhang, Ph.D.,MD
• Phone: 8624 31927811
• Email: zhangxiamd[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 15, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Elective Reconstructive Surgery
• Pain, Post Operative
• Pain, Postoperative

Intervention

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.

Locations

Country	Name	City	State
China	School & Hospital of Stomatology, China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Xia Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	duration of sensory blockade	the time of sensory recovery	48 hours
Primary	duration of motor blockade	the time of motor recovery	48 hours
Primary	onset of sensory blockade	the time to sensory blockade	48 hours
Primary	onset of motor blockade	the time to motor blockade	48 hours
Secondary	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
Secondary	vital signs	hear rate, blood pressure, SPO2	48 hours
Secondary	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
Secondary	adverse effects	such as bradycardia, hypotension,respiratory depression, postoperative sedation	48 hours