Elective Reconstructive SurgeryNCT03071185
The Efficacy and Safety of Lower Limb Nerve Blocks in Postoperative Analgesia for the Free Flap Donor Sites
A study testing femoral nerve block, common peroneal nerve block in people with Elective Reconstructive Surgery and Pain, Post Operative, run by Xia Zhang at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elective Reconstructive Surgery, Pain, Post Operative
- What is being tested?
- femoral nerve block, common peroneal nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2017to 15 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
School & Hospital of Stomatology, China Medical University
Shenyang, Liaoning, 110002
xia zhang
About this study
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.
Read the 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.
- Being tested
- femoral nerve block, common peroneal nerve block
- Keywords
- free flap, nerve block, elective reconstructive surgery, dexmedetomidine, anterolateral thigh flaps
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
femoral nerve block, common peroneal nerve blockProcedure or surgery
Also called lower limb blocks with dexmedetomidine as additivewere
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: femoral nerve block, common peroneal nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours
duration of sensory blockade
the time of sensory recovery
Measured: 48 hours
duration of motor blockade
the time of motor recovery
Measured: 48 hours
onset of sensory blockade
the time to sensory blockade
Measured: 48 hours
onset of motor blockade
the time to motor blockade
Measured: 48 hours
Secondary outcomes (4)
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.
Measured: 48 hours
vital signs
hear rate, blood pressure, SPO2
Measured: 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.
Measured: 48 hours
adverse effects
such as bradycardia, hypotension,respiratory depression, postoperative sedation
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study start20 Jan 2017
- Primary completion15 Nov 2022 (estimated)
- Study completion15 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Reconstructive SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xia Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xia Zhang, China Medical University, China
- Investigators
- xia zhang, Ph.D,MD, Principal investigator, School & Hospital of Stomatology, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071185
- Sponsor's protocol ID
- ChinaMedicalU
- Status last verified
- Nov 2022
- First submitted
- 1 Mar 2017
- Last updated
- 25 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Lower Limb Nerve Blocks in Postoperative Analgesia for the Free Flap Donor Sites
- ClinicalTrials.gov ID
- NCT03071185
- Acronym / sponsor ID
- ChinaMedicalU
- Keywords
- free flap, nerve block, elective reconstructive surgery, dexmedetomidine, anterolateral thigh flaps
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xia ZhangUniversity, hospital or other
- Study start
- 20 Jan 2017 (actual)
- Primary completion
- 15 Nov 2022 (estimated)
- Study completion
- 15 Nov 2022 (estimated)
- First posted
- 6 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group PCA+B | Experimental | Procedure: femoral nerve block, common peroneal nerve blockBoth 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 PCA | No intervention | –Only intravenous patient controlled analgesia (PCA) was used postoperatively. |
| Group PCA+B+D | Experimental | Procedure: femoral nerve block, common peroneal nerve blockBoth intravenous PCA and lower limb blocks with dexmedetomidine as additivewere used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| femoral nerve block, common peroneal nerve blockAlso: lower limb blocks with dexmedetomidine as additivewereFor 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. | Procedure or surgery | Group PCA+B, Group PCA+B+D |
Primary outcome
Post-operative Narcotic Usage
Time frame: 48 hours
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
Time frame: 48 hours
the time of sensory recovery
duration of motor blockade
Time frame: 48 hours
the time of motor recovery
onset of sensory blockade
Time frame: 48 hours
the time to sensory blockade
onset of motor blockade
Time frame: 48 hours
the time to motor blockade
4 secondary outcomes
Post-operative Anti-emetic Usage
Time frame: 48 hours
vital signs
Time frame: 48 hours
Post-operative Pain Score
Time frame: 48 hours
adverse effects
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Elective Reconstructive Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xia zhang, Ph.D,MD principal investigator
School & Hospital of Stomatology, China Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing femoral nerve block, common peroneal nerve block in people with Elective Reconstructive Surgery and Pain, Post Operative, run by Xia Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xia zhang, Ph.D.,MD (8624 31927811, zhangxiamd@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Narcotic Usage (time frame: 48 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2022.