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

NCT05805423 | Active Not Recruiting

• 1 other identifier: 1958184
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

bilateral superficial cervical plexus block; post operative pain after thyroidectomy

Outcome Measures

Primary Outcomes (8)

• 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

  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

  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

  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

  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

  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.

  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.

  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.

  2 weeks +/- 3 days postoperatively (at their follow up video visit)

Secondary Outcomes (4)

• hoarseness

  assessed at 3-5 hours (in post anesthesia care unit [PACU])

• hoarseness

  post operative day 2, via telephone call

• dysphagia (difficulty swallowing)

  assessed at 3-5 hours (in post anesthesia care unit [PACU])

• dysphagia (difficulty swallowing)

  post operative day 2, via telephone call

Study Arms (2)

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

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.

Procedure: placebo injection and local wound infiltration

Interventions

placebo injection and local wound infiltration PROCEDURE

10mL normal saline at Erb's point bilaterally and 10mL 0.25% Bupicacaine at incision

placebo + local wound infiltration

bilateral superficial cervical plexus blocks and local wound infiltration PROCEDURE

10mL bupivacaine at Erb's point bilaterally and 10mL 0.25% Bupicacaine at incision

Bilateral superficial cervical plexus blocks + local wound infiltration

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing thyroid surgery, either hemi- or total thyroidectomy
• over 18 years-old and
• able to consent for themselves

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Publications (7)

• 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.

  PMID: 29969890 BACKGROUND

• 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.

  PMID: 29406173 BACKGROUND

• 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.

  PMID: 11375842 BACKGROUND

• 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.

  PMID: 23279371 BACKGROUND

• 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.

  PMID: 22971490 BACKGROUND

• 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.

  PMID: 16551919 BACKGROUND

• 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.

  PMID: 35430086 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single center, prospective, double-blinded randomized controlled trial

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 10, 2023
• Study Start: April 17, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)