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ENDOblock: Bilateral Superficial Cervical Blocks With Local Wound Infiltration in Thyroid Surgery

Primary Purpose

Post Operative Pain, Nausea and Vomiting, Postoperative, Opioid Use

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
bilateral superficial cervical plexus blocks and local wound infiltration
placebo injection and local wound infiltration
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post Operative Pain focused on measuring bilateral superficial cervical plexus block, post operative pain after thyroidectomy

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: undergoing thyroid surgery, either hemi- or total thyroidectomy over 18 years-old and able to consent for themselves Exclusion Criteria: have had previous neck surgery have coagulation disorders on anticoagulants are pregnant allergic to bupivacaine anyone with chronic pain conditions has received steroid injections or used opioids/pain medications in the two weeks leading up to surgery have a substernal goiters undergoing lateral neck lymph node dissection unable to take NSAIDs kidney dysfunction (defined as GFR <60) within 90 days of surgery, prohibiting the use of NSAIDs

Sites / Locations

  • UC Davis Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bilateral superficial cervical plexus blocks + local wound infiltration

placebo + local wound infiltration

Arm Description

the bilateral superficial cervical plexus block will be performed with 10mL of 0.25% Bupivacaine injected bilaterally (total 20mL) at Erb's point in the lateral neck, which is located at the mid-point between the mastoid process and the posterior border of the clavicular head of the sternocleidomastoid muscle. The injection is just below the lateral border of the sternocleidomastoid muscle, which produces surface level anesthesia of the neck, targeting superficial nerves of the cervical plexus. Then 10mL of 0.25% Bupivacaine will be injected at the planned neck incision (local wound infiltration) on the anterior neck. These will be done intra-operative and only once

10mL of 0.25% bupivacaine injected at the planned neck incision (local wound infiltration), with 10mL of normal saline injected at bilateral Erb's point (total 20mL) (placebo at site of BSCPB). These will be done intra-operative and only once.

Outcomes

Primary Outcome Measures

does the addition of bilateral superficial cervical plexus blocks with local wound infiltration decrease postoperative pain after thyroid surgery
Neck pain intensity will be quantified using the numeric rating scale (visual analog score 0-10, VAS). Higher scores mean more pain. Lower scores are a better outcome
does the addition of bilateral superficial cervical plexus blocks with local wound infiltration decrease postoperative pain after thyroid surgery
Neck pain intensity will be quantified using the numeric rating scale (visual analog score 0-10, VAS). Higher scores mean more pain. Lower scores are a better outcome
does the addition of bilateral superficial cervical plexus blocks with local wound infiltration decrease postoperative pain after thyroid surgery
Neck pain intensity will be quantified using the numeric rating scale (visual analog score 0-10, VAS). Higher scores mean more pain. Lower scores are a better outcome
does the addition of bilateral superficial cervical plexus blocks with local wound infiltration increase patient quality of life/recovery after thyroid surgery
15-item Quality of recovery (QoR) after anesthesia is a validated self reported measure of the early postoperative health status of patients. highest score possible 150, lowest 0. higher score means better quality of life and recovery
does the addition of bilateral superficial cervical plexus blocks with local wound infiltration increase patient quality of life/recovery after thyroid surgery
15-item Quality of recovery (QoR) after anesthesia is a validated self reported measure of the early postoperative health status of patients. highest score possible 150, lowest 0. higher score means better quality of life and recovery
Incidence of nausea and/or vomiting post operatively
patients are given a questionnaire assessing level of nausea on scale 0-10, higher score is more nauseated and worse outcome. yes/no question if they have vomited since surgery and how many times. more episodes of vomiting is worse outcome.
Incidence of nausea and/or vomiting post operatively
patients are given a questionnaire assessing level of nausea on scale 0-10, higher score is more nauseated and worse outcome. yes/no question if they have vomited since surgery and how many times. more episodes of vomiting is worse outcome.
Incidence of nausea and/or vomiting post operatively
patients are given a questionnaire assessing level of nausea on scale 0-10, higher score is more nauseated and worse outcome. yes/no question if they have vomited since surgery and how many times. more episodes of vomiting is worse outcome.

Secondary Outcome Measures

hoarseness
yes/no question on survey- yes answer is worse outcome
hoarseness
yes/no question on survey- yes answer is worse outcome
dysphagia (difficulty swallowing)
yes/no question on survey- yes answer is worse outcome
dysphagia (difficulty swallowing)
yes/no question on survey- yes answer is worse outcome

Full Information

First Posted
March 14, 2023
Last Updated
May 9, 2023
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT05805423
Brief Title
ENDOblock: Bilateral Superficial Cervical Blocks With Local Wound Infiltration in Thyroid Surgery
Official Title
ENDOblock: Do Bilateral Superficial Cervical Blocks With Local Wound Infiltration Decrease Postoperative Pain After Thyroid Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a single center, prospective, double-blinded randomized controlled trial comparing the efficacy of bilateral superficial cervical plexus blocks (BSCPB) with local wound infiltration vs placebo with local wound infiltration in reducing thyroid surgery postoperative pain. Primary outcomes assessed are post operative pain, quality of life/recovery, post operative nausea/vomiting and opioid use.
Detailed Description
The study consists of enrollment period until 74 participants acquired (37 will be in each arm), a treatment period (day of surgery), and a 2 week follow up period. A web-based randomizer (https://randomizer.org/) will be used to randomly assign participants into Group A (bilateral superficial cervical plexus blocks + local wound infiltration) and Group B (placebo + local wound infiltration). Numbered envelopes with respective assignments and medications sealed within will be prepared by a research assistant separate from the surgical team and brought to the operating theater together with subjects. Participants and surgeons will both be blinded to the intervention. Induction of anesthesia will occur prior to performing a block. All participants will be closely monitored by anesthesia, including BP, HR, SpO2, tidal volumes, peak pressures, CO2. Participants who are randomized to the bilateral superficial cervical plexus blocks + local wound infiltration (Group A) will have 10mL of 0.25% Bupivacaine injected bilaterally (total 20mL) at Erb's point, which is located at the mid-point between the mastoid process and the posterior border of the clavicular head of the sternocleidomastoid muscle (SCM). The injection is just below the lateral border of the SCM, which produces surface level anesthesia of the neck, targeting superficial nerves of the cervical plexus (1). Injections will be aimed at just below the dermis. Then 10mL of 0.25% Bupivacaine will be injected at the planned neck incision (local wound infiltration). The participants randomized to the placebo+local wound infiltration group will have 10mL of 0.25% Bupivacaine injected at the planned neck incision, with 10mL of normal saline injected at bilateral Erb's point (total 20mL). All injections will be performed by the same team of two surgeons and with 22 gauge needles to standardize the technique. Surgery will be performed according to standard clinical care, also by the same group of surgeons, standardizing the surgical technique. As is our standard practice following thyroid surgery, participants will be observed for at least 4 hours in the post anesthesia care unit for postoperative complications, adequate pain control, neck hematoma, and possible complications from the BSCPB. These rare complications can include CNS toxicity, partial brachial plexus palsy, Horner's syndrome, or recurrent laryngeal nerve block. All participants will be assessed at 3-5 hours after surgery to ensure their post operative pain is acceptable on oral medications and they do not have any of the above complications. They will either stay overnight or be discharged home with standardized discharge instructions and pain medication regimen, which will include taking Tylenol every 6 hours, alternated with ibuprofen. This pain regimen will be used for participants unless changed for clinical contraindications as determined by the attending surgeon. If participants request additional medication, they will be prescribed with a few pills of 5mg oxycodone, which they can take up to every 4 hours. A primary outcome will be postoperative pain. Neck pain intensity will be quantified using the numeric rating scale (visual analog score 0-10, VAS) at 3-5 hours (in post anesthesia care unit), post operative day 2, via telephone call, and 2 weeks +/- 3 days postoperatively (at their follow up video visit). In addition, comparisons between groups will be made for 48-hour opioid usage by participants self-reporting at the post operative day 2 follow up phone call. Another primary outcome is the 15-item quality of recovery questionnaire score at post operative day 2 and two weeks postoperative. Incidence of nausea, vomiting, dysphagia or hoarseness in the first 2 days after surgery will also be measured (roughly the first 48 hours after surgery). The planned data analysis for quality of recovery scores will be done using independent t test, with 95% confidence interval and two-tailed p values reported. Significance levels will be set at p=0.05. The investigators plan to analyze pain scores across the 3 periods with linear regression, with output the difference between the groups across all periods (95% CI and p=0.05) and the difference between the groups in each period (95% CI and p=0.05). The 48-hour opioid usage will be likely analyzed by using independent t test with 95% confidence intervals and two-tailed p values reported (p=0.05). Nausea, vomiting, hoarseness, dysphagia will be recorded as categorical variables and the investigators plan to analyze them using the Pearson chi-squared test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Nausea and Vomiting, Postoperative, Opioid Use
Keywords
bilateral superficial cervical plexus block, post operative pain after thyroidectomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
single center, prospective, double-blinded randomized controlled trial
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bilateral superficial cervical plexus blocks + local wound infiltration
Arm Type
Experimental
Arm Description
the bilateral superficial cervical plexus block will be performed with 10mL of 0.25% Bupivacaine injected bilaterally (total 20mL) at Erb's point in the lateral neck, which is located at the mid-point between the mastoid process and the posterior border of the clavicular head of the sternocleidomastoid muscle. The injection is just below the lateral border of the sternocleidomastoid muscle, which produces surface level anesthesia of the neck, targeting superficial nerves of the cervical plexus. Then 10mL of 0.25% Bupivacaine will be injected at the planned neck incision (local wound infiltration) on the anterior neck. These will be done intra-operative and only once
Arm Title
placebo + local wound infiltration
Arm Type
Placebo Comparator
Arm Description
10mL of 0.25% bupivacaine injected at the planned neck incision (local wound infiltration), with 10mL of normal saline injected at bilateral Erb's point (total 20mL) (placebo at site of BSCPB). These will be done intra-operative and only once.
Intervention Type
Procedure
Intervention Name(s)
bilateral superficial cervical plexus blocks and local wound infiltration
Intervention Description
10mL bupivacaine at Erb's point bilaterally and 10mL 0.25% Bupicacaine at incision
Intervention Type
Procedure
Intervention Name(s)
placebo injection and local wound infiltration
Intervention Description
10mL normal saline at Erb's point bilaterally and 10mL 0.25% Bupicacaine at incision
Primary Outcome Measure Information:
Title
does the addition of bilateral superficial cervical plexus blocks with local wound infiltration decrease postoperative pain after thyroid surgery
Description
Neck pain intensity will be quantified using the numeric rating scale (visual analog score 0-10, VAS). Higher scores mean more pain. Lower scores are a better outcome
Time Frame
assessed at 3-5 hours (in post anesthesia care unit [PACU])
Title
does the addition of bilateral superficial cervical plexus blocks with local wound infiltration decrease postoperative pain after thyroid surgery
Description
Neck pain intensity will be quantified using the numeric rating scale (visual analog score 0-10, VAS). Higher scores mean more pain. Lower scores are a better outcome
Time Frame
post operative day 2, via telephone call
Title
does the addition of bilateral superficial cervical plexus blocks with local wound infiltration decrease postoperative pain after thyroid surgery
Description
Neck pain intensity will be quantified using the numeric rating scale (visual analog score 0-10, VAS). Higher scores mean more pain. Lower scores are a better outcome
Time Frame
2 weeks +/- 3 days postoperatively (at their follow up video visit)
Title
does the addition of bilateral superficial cervical plexus blocks with local wound infiltration increase patient quality of life/recovery after thyroid surgery
Description
15-item Quality of recovery (QoR) after anesthesia is a validated self reported measure of the early postoperative health status of patients. highest score possible 150, lowest 0. higher score means better quality of life and recovery
Time Frame
post operative day 2, via telephone call
Title
does the addition of bilateral superficial cervical plexus blocks with local wound infiltration increase patient quality of life/recovery after thyroid surgery
Description
15-item Quality of recovery (QoR) after anesthesia is a validated self reported measure of the early postoperative health status of patients. highest score possible 150, lowest 0. higher score means better quality of life and recovery
Time Frame
2 weeks +/- 3 days postoperatively (at their follow up video visit)
Title
Incidence of nausea and/or vomiting post operatively
Description
patients are given a questionnaire assessing level of nausea on scale 0-10, higher score is more nauseated and worse outcome. yes/no question if they have vomited since surgery and how many times. more episodes of vomiting is worse outcome.
Time Frame
assessed at 3-5 hours (in post anesthesia care unit [PACU])
Title
Incidence of nausea and/or vomiting post operatively
Description
patients are given a questionnaire assessing level of nausea on scale 0-10, higher score is more nauseated and worse outcome. yes/no question if they have vomited since surgery and how many times. more episodes of vomiting is worse outcome.
Time Frame
post operative day 2 via telephone
Title
Incidence of nausea and/or vomiting post operatively
Description
patients are given a questionnaire assessing level of nausea on scale 0-10, higher score is more nauseated and worse outcome. yes/no question if they have vomited since surgery and how many times. more episodes of vomiting is worse outcome.
Time Frame
2 weeks +/- 3 days postoperatively (at their follow up video visit)
Secondary Outcome Measure Information:
Title
hoarseness
Description
yes/no question on survey- yes answer is worse outcome
Time Frame
assessed at 3-5 hours (in post anesthesia care unit [PACU])
Title
hoarseness
Description
yes/no question on survey- yes answer is worse outcome
Time Frame
post operative day 2, via telephone call
Title
dysphagia (difficulty swallowing)
Description
yes/no question on survey- yes answer is worse outcome
Time Frame
assessed at 3-5 hours (in post anesthesia care unit [PACU])
Title
dysphagia (difficulty swallowing)
Description
yes/no question on survey- yes answer is worse outcome
Time Frame
post operative day 2, via telephone call

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: undergoing thyroid surgery, either hemi- or total thyroidectomy over 18 years-old and able to consent for themselves Exclusion Criteria: have had previous neck surgery have coagulation disorders on anticoagulants are pregnant allergic to bupivacaine anyone with chronic pain conditions has received steroid injections or used opioids/pain medications in the two weeks leading up to surgery have a substernal goiters undergoing lateral neck lymph node dissection unable to take NSAIDs kidney dysfunction (defined as GFR <60) within 90 days of surgery, prohibiting the use of NSAIDs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexis L Woods, MD
Phone
2794657077
Email
alwoods@ucdavis.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Claire E Graves, MD
Phone
9167345907
Email
cegraves@ucdavis.edu
Facility Information:
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexis L Woods, MD
Phone
279-465-7077
Email
alwoods@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Claire E Graves, MD
First Name & Middle Initial & Last Name & Degree
Michael Campbell, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29969890
Citation
Kim JS, Ko JS, Bang S, Kim H, Lee SY. Cervical plexus block. Korean J Anesthesiol. 2018 Aug;71(4):274-288. doi: 10.4097/kja.d.18.00143. Epub 2018 Jul 4.
Results Reference
background
PubMed Identifier
29406173
Citation
Mayhew D, Sahgal N, Khirwadkar R, Hunter JM, Banerjee A. Analgesic efficacy of bilateral superficial cervical plexus block for thyroid surgery: meta-analysis and systematic review. Br J Anaesth. 2018 Feb;120(2):241-251. doi: 10.1016/j.bja.2017.11.083. Epub 2017 Dec 5.
Results Reference
background
PubMed Identifier
11375842
Citation
Dieudonne N, Gomola A, Bonnichon P, Ozier YM. Prevention of postoperative pain after thyroid surgery: a double-blind randomized study of bilateral superficial cervical plexus blocks. Anesth Analg. 2001 Jun;92(6):1538-42. doi: 10.1097/00000539-200106000-00038.
Results Reference
background
PubMed Identifier
23279371
Citation
Karthikeyan VS, Sistla SC, Badhe AS, Mahalakshmy T, Rajkumar N, Ali SM, Gopalakrishnan S. Randomized controlled trial on the efficacy of bilateral superficial cervical plexus block in thyroidectomy. Pain Pract. 2013 Sep;13(7):539-46. doi: 10.1111/papr.12022. Epub 2012 Dec 19.
Results Reference
background
PubMed Identifier
22971490
Citation
Cai HD, Lin CZ, Yu CX, Lin XZ. Bilateral superficial cervical plexus block reduces postoperative nausea and vomiting and early postoperative pain after thyroidectomy. J Int Med Res. 2012;40(4):1390-8. doi: 10.1177/147323001204000417.
Results Reference
background
PubMed Identifier
16551919
Citation
Eti Z, Irmak P, Gulluoglu BM, Manukyan MN, Gogus FY. Does bilateral superficial cervical plexus block decrease analgesic requirement after thyroid surgery? Anesth Analg. 2006 Apr;102(4):1174-6. doi: 10.1213/01.ane.0000202383.51830.c4.
Results Reference
background
PubMed Identifier
35430086
Citation
Myles PS, Shulman MA, Reilly J, Kasza J, Romero L. Measurement of quality of recovery after surgery using the 15-item quality of recovery scale: a systematic review and meta-analysis. Br J Anaesth. 2022 Jun;128(6):1029-1039. doi: 10.1016/j.bja.2022.03.009. Epub 2022 Apr 14.
Results Reference
background

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ENDOblock: Bilateral Superficial Cervical Blocks With Local Wound Infiltration in Thyroid Surgery

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