Analgesia Obtained With a Local Wound Infiltration of LidocainBSCPB_BlockNCT04993521
Ultrasound Guided Bilateral Superficial Cervical Plexus Block in Patients Undergoing Total Thyroidectomy.
A study testing Block type in people with Analgesia Obtained With a Local Wound Infiltration of Lidocain and Analgesia Obtained With a Ultrasound Guided Cervical Plexus Block Using Lidocain, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
The present study compared the efficacy of bilateral superficial cervical plexus block (BSCPB) versus local wound infiltration (LWI) regarding the postoperative opioid consumption in patients undergoing total thyroidectomy Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Analgesia Obtained With a Local Wound Infiltration of Lidocain, Analgesia Obtained With a Ultrasound Guided Cervical Plexus Block Using Lidocain, Postoperative Pain
- What is being tested?
- Block type
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2019to 15 May 2021
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II, and were scheduled for total thyroidectomy
- -
Who cannot join
- documented allergy to study's intervention, moderate-to-severe obesity, > 1st-degree heart block, chronic pulmonary or cardiac diseases, hepatic or renal dysfunction, and/or coagulopathies.
- All patients were required to fill the informed consent before enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Bilateral Superficial Cervical Plexus Block Versus Local Wound Infiltration in Patients Undergoing Total Thyroidectomy: A Randomized Controlled Study
The present study compared the efficacy of bilateral superficial cervical plexus block (BSCPB) versus local wound infiltration (LWI) regarding the postoperative opioid consumption in patients undergoing total thyroidectomy
Read the detailed description
We performed a double-blind, randomised, controlled trial that recruited patients undergoing total thyroidectomy at the Suez Canal University Hospital during the period between February 2019 and January 2021. Patients were eligible if they were older than 20 years, had an American Association of Anesthesiologists' (ASA) level of I-II, and were scheduled for total thyroidectomy. We excluded patients with documented allergies to the study's intervention materials, moderate-to-severe obesity, > 1st-degree heart block, chronic pulmonary or cardiac diseases, hepatic or renal dysfunction, and/or coagulopathies. All patients were required to fill out informed consent before enrollment.
Eligible patients were randomly allocated in a 1:1 ratio to receive BSCPB or LWI using the computer software program (www. Randmizer.org) and allocation sequences were done using opaque, closed envelopes. The BSCPB group received BSCBP (after general anaesthesia but before the start of surgery) from two syringes containing ropivacaine 0.5 % and LWI with saline. The LWI group received LWI with ropivacaine 0.5% and the BSCPB from two syringes containing saline.
The primary outcome of the present study was postoperative opioid consumption in the first postoperative day. The secondary outcomes included the total intraoperative fentanyl and isoflurane consumption, time to first required analgesic, and VAS during the first 24 hours postoperatively.
- Conditions
- Analgesia Obtained With a Local Wound Infiltration of Lidocain, Analgesia Obtained With a Ultrasound Guided Cervical Plexus Block Using Lidocain, Postoperative Pain
- Being tested
- Block type
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Block typeProcedure or surgery
Also called Ultrasound guided bilateral superficial cervical plexus nerve block
Regular block type
| Study group | Role | What they receive |
|---|---|---|
| bilateral superficial cervical plexus block (BSCPB) | Active comparator | Analgesia obtained by a ultrasound guided cervical plexus block using lidocain Receives: Procedure: Block type |
| local wound infiltration (LWI) | Active comparator | Analgesia obtained by local wound infiltration of lidocain Receives: Procedure: Block type |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative opioid consumption in the first postoperative day
postoperative opioid consumption in the first postoperative day in milligrams
Measured: 24 hours
Secondary outcomes (3)
total intraoperative fentanyl (mg) and isoflurane consumption (ml)
total intraoperative fentanyl and isoflurane consumption in micrograms and ml
Measured: 6 hours
time to first required analgesic
time to first required analgesic
Measured: 6 hours
VAS (10 cm; range): Pain average (VAS) for the first 24 hours postoperatively
VAS (10 cm; range) Pain average (VAS) for the first 24 hours postoperatively
Measured: every 6 hours until 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start1 Feb 2019
- Primary completion31 Jan 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia Obtained With a Local Wound Infiltration of LidocainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized Controlled Study
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Collaborators
- Ahmed Mohamed Abdelrahman, Mahmoud Ahmed Mewafy, Abdelrhman Alshawadfy, Haidi Abd-Elzaher, Hamada Fathy, Mohamed Faisal
- Responsible party
- Principal investigator, Folke Sjoberg, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993521
- Sponsor's protocol ID
- BSCPB_Block
- Acronym
- BSCPB_Block
- Status last verified
- Jul 2021
- First submitted
- 10 Jun 2021
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Can be shared on reasonable terms
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Bilateral Superficial Cervical Plexus Block Versus Local Wound Infiltration in Patients Undergoing Total Thyroidectomy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04993521
- Acronym / sponsor ID
- BSCPB_Block / BSCPB_Block
- Conditions
- Analgesia Obtained With a Local Wound Infiltration of Lidocain, Analgesia Obtained With a Ultrasound Guided Cervical Plexus Block Using Lidocain, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Collaborators
- Ahmed Mohamed Abdelrahman, Mahmoud Ahmed Mewafy, Abdelrhman Alshawadfy, Haidi Abd-Elzaher, Hamada Fathy, Mohamed Faisal
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 6 Aug 2021 (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 present study compared the efficacy of bilateral superficial cervical plexus block (BSCPB) versus local wound infiltration (LWI) regarding the postoperative opioid consumption in patients undergoing total thyroidectomy
Detailed description
We performed a double-blind, randomised, controlled trial that recruited patients undergoing total thyroidectomy at the Suez Canal University Hospital during the period between February 2019 and January 2021. Patients were eligible if they were older than 20 years, had an American Association of Anesthesiologists' (ASA) level of I-II, and were scheduled for total thyroidectomy. We excluded patients with documented allergies to the study's intervention materials, moderate-to-severe obesity, > 1st-degree heart block, chronic pulmonary or cardiac diseases, hepatic or renal dysfunction, and/or coagulopathies. All patients were required to fill out informed consent before enrollment.
Eligible patients were randomly allocated in a 1:1 ratio to receive BSCPB or LWI using the computer software program (www. Randmizer.org) and allocation sequences were done using opaque, closed envelopes. The BSCPB group received BSCBP (after general anaesthesia but before the start of surgery) from two syringes containing ropivacaine 0.5 % and LWI with saline. The LWI group received LWI with ropivacaine 0.5% and the BSCPB from two syringes containing saline.
The primary outcome of the present study was postoperative opioid consumption in the first postoperative day. The secondary outcomes included the total intraoperative fentanyl and isoflurane consumption, time to first required analgesic, and VAS during the first 24 hours postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| bilateral superficial cervical plexus block (BSCPB) | Active comparator | Procedure: Block typeAnalgesia obtained by a ultrasound guided cervical plexus block using lidocain |
| local wound infiltration (LWI) | Active comparator | Procedure: Block typeAnalgesia obtained by local wound infiltration of lidocain |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-II, and were scheduled for total thyroidectomy
- -
Key exclusion criteria (2 listed)
- documented allergy to study's intervention, moderate-to-severe obesity, > 1st-degree heart block, chronic pulmonary or cardiac diseases, hepatic or renal dysfunction, and/or coagulopathies.
- All patients were required to fill the informed consent before enrollment.
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 |
|---|---|---|
| Block typeAlso: Ultrasound guided bilateral superficial cervical plexus nerve blockRegular block type | Procedure or surgery | bilateral superficial cervical plexus block (BSCPB), local wound infiltration (LWI) |
Primary outcome
postoperative opioid consumption in the first postoperative day
Time frame: 24 hours
postoperative opioid consumption in the first postoperative day in milligrams
3 secondary outcomes
total intraoperative fentanyl (mg) and isoflurane consumption (ml)
Time frame: 6 hours
time to first required analgesic
Time frame: 6 hours
VAS (10 cm; range): Pain average (VAS) for the first 24 hours postoperatively
Time frame: every 6 hours until 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Individual participant dataSharing planned: No. Can be shared on reasonable terms
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Block type in people with Analgesia Obtained With a Local Wound Infiltration of Lidocain and Analgesia Obtained With a Ultrasound Guided Cervical Plexus Block Using Lidocain, run by University Hospital, Linkoeping at 1 site in Sweden.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 6 Aug 2021. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative opioid consumption in the first postoperative day (time frame: 24 hours). 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 6 Aug 2021.