Post Operative PainNCT05805423
ENDOblock: Bilateral Superficial Cervical Blocks With Local Wound Infiltration in Thyroid Surgery
A study testing bilateral superficial cervical plexus blocks and local wound infiltration in people with Post Operative Pain and Nausea and Vomiting, Postoperative, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain, Nausea and Vomiting, Postoperative, Opioid Use
- What is being tested?
- bilateral superficial cervical plexus blocks and local wound infiltration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- undergoing thyroid surgery, either hemi- or total thyroidectomy
- over 18 years-old and
- able to consent for themselves
Who cannot join
- have had previous neck surgery
- have coagulation disorders
- on anticoagulants
- are pregnant
- allergic to bupivacaine
- anyone with chronic pain conditions
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
Official title: ENDOblock: Do Bilateral Superficial Cervical Blocks With Local Wound Infiltration Decrease Postoperative Pain After Thyroid Surgery
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.
Read the 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.
- Being tested
- bilateral superficial cervical plexus blocks and local wound infiltration, placebo injection and local wound infiltration
- Keywords
- bilateral superficial cervical plexus block, post operative pain after thyroidectomy
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral superficial cervical plexus blocks and local wound infiltrationProcedure or surgery
10mL bupivacaine at Erb's point bilaterally and 10mL 0.25% Bupicacaine at incision
placebo injection and local wound infiltrationProcedure or surgery
10mL normal saline at Erb's point bilaterally and 10mL 0.25% Bupicacaine at incision
| Study group | Role | What they receive |
|---|---|---|
| Bilateral superficial cervical plexus blocks + local wound infiltration | Experimental | 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 Receives: Procedure: bilateral superficial cervical plexus blocks and local wound infiltration |
| placebo + local wound infiltration | Placebo comparator | 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. Receives: Procedure: placebo injection and local wound infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: assessed at 3-5 hours (in post anesthesia care unit [PACU])
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
Measured: post operative day 2, via telephone call
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
Measured: 2 weeks +/- 3 days postoperatively (at their follow up video visit)
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
Measured: post operative day 2, via telephone call
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
Measured: 2 weeks +/- 3 days postoperatively (at their follow up video visit)
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.
Measured: assessed at 3-5 hours (in post anesthesia care unit [PACU])
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.
Measured: post operative day 2 via telephone
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.
Measured: 2 weeks +/- 3 days postoperatively (at their follow up video visit)
Secondary outcomes (4)
hoarseness
yes/no question on survey- yes answer is worse outcome
Measured: assessed at 3-5 hours (in post anesthesia care unit [PACU])
hoarseness
yes/no question on survey- yes answer is worse outcome
Measured: post operative day 2, via telephone call
dysphagia (difficulty swallowing)
yes/no question on survey- yes answer is worse outcome
Measured: assessed at 3-5 hours (in post anesthesia care unit [PACU])
dysphagia (difficulty swallowing)
yes/no question on survey- yes answer is worse outcome
Measured: post operative day 2, via telephone call
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start17 Apr 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Model description
- single center, prospective, double-blinded randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805423
- Sponsor's protocol ID
- 1958184
- Status last verified
- May 2026
- First submitted
- 14 Mar 2023
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29969890Mayhew 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.
PubMed 29406173Dieudonne 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.
PubMed 11375842Karthikeyan 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.
PubMed 23279371Cai 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.
PubMed 22971490Eti 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.
PubMed 16551919Myles 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.
PubMed 35430086
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENDOblock: Do Bilateral Superficial Cervical Blocks With Local Wound Infiltration Decrease Postoperative Pain After Thyroid Surgery
- ClinicalTrials.gov ID
- NCT05805423
- Acronym / sponsor ID
- 1958184
- Keywords
- bilateral superficial cervical plexus block, post operative pain after thyroidectomy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Apr 2023 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- single center, prospective, double-blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Bilateral superficial cervical plexus blocks + local wound infiltration | Experimental | Procedure: bilateral superficial cervical plexus blocks and local wound infiltrationthe 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 |
| placebo + local wound infiltration | Placebo comparator | Procedure: placebo injection and local wound infiltration10mL 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- undergoing thyroid surgery, either hemi- or total thyroidectomy
- over 18 years-old and
- able to consent for themselves
Key exclusion criteria (11 listed)
- have had previous neck surgery
- have coagulation disorders
- on anticoagulants
- are pregnant
- allergic to bupivacaine
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 |
|---|---|---|
| bilateral superficial cervical plexus blocks and local wound infiltration10mL bupivacaine at Erb's point bilaterally and 10mL 0.25% Bupicacaine at incision | Procedure or surgery | Bilateral superficial cervical plexus blocks + local wound infiltration |
| placebo injection and local wound infiltration10mL normal saline at Erb's point bilaterally and 10mL 0.25% Bupicacaine at incision | Procedure or surgery | placebo + local wound infiltration |
Primary outcome
does the addition of bilateral superficial cervical plexus blocks with local wound infiltration decrease postoperative pain after thyroid surgery
Time frame: assessed at 3-5 hours (in post anesthesia care unit [PACU])
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
Time frame: post operative day 2, via telephone call
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
Time frame: 2 weeks +/- 3 days postoperatively (at their follow up video visit)
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
Time frame: post operative day 2, via telephone call
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
Time frame: 2 weeks +/- 3 days postoperatively (at their follow up video visit)
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
Time frame: assessed at 3-5 hours (in post anesthesia care unit [PACU])
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
Time frame: post operative day 2 via telephone
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
Time frame: 2 weeks +/- 3 days postoperatively (at their follow up video visit)
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.
4 secondary outcomes
hoarseness
Time frame: assessed at 3-5 hours (in post anesthesia care unit [PACU])
hoarseness
Time frame: post operative day 2, via telephone call
dysphagia (difficulty swallowing)
Time frame: assessed at 3-5 hours (in post anesthesia care unit [PACU])
dysphagia (difficulty swallowing)
Time frame: post operative day 2, via telephone call
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Background: PubMed 29969890Kim 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.
- Background: PubMed 29406173Mayhew 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.
- Background: PubMed 11375842Dieudonne 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.
- Background: PubMed 23279371Karthikeyan 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.
- Background: PubMed 22971490Cai 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.
- Background: PubMed 16551919Eti 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.
- Background: PubMed 35430086Myles 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.
- Individual participant dataSharing planned: No
Related trials for Post Operative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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 bilateral superficial cervical plexus blocks and local wound infiltration in people with Post Operative Pain and Nausea and Vomiting, Postoperative, run by University of California, Davis at 1 site in United States.
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 3 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. 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 United States. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
does the addition of bilateral superficial cervical plexus blocks with local wound infiltration decrease postoperative pain after thyroid surgery (time frame: assessed at 3-5 hours (in post anesthesia care unit [PACU])). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05805423, which also lists 7 linked publications.
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 12 May 2026.