PMID- 34187541
OWN - NLM
STAT- MEDLINE
DCOM- 20210701
LR  - 20220531
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 22
IP  - 1
DP  - 2021 Jun 29
TI  - Bilateral cervical plexus block for anterior cervical spine surgery: study 
      protocol for a randomised placebo-controlled trial.
PG  - 424
LID - 10.1186/s13063-021-05377-4 [doi]
LID - 424
AB  - BACKGROUND: There has been increasing focus to improve the quality of recovery 
      following anterior cervical spine surgery (ACSS). Postoperative pain and nausea 
      are the most common reasons for prolonged hospital stay and readmission after 
      ACSS. Superficial cervical plexus block (SCPB) provides site-specific analgesia 
      with minimal side effects, thereby improving the quality of recovery. The aim of 
      our study was to investigate the effect bilateral cervical plexus block has on 
      postoperative recovery in patients undergoing ACSS. METHODS: The study is a 
      pragmatic, multi-centre, blinded, parallel-group, randomised placebo-controlled 
      trial. 136 eligible patients (68 in each group) undergoing ACSS will be included. 
      Patients randomised to the intervention group will have a SCPB administered under 
      ultrasound guidance with a local anaesthetic solution (0.2% ropivacaine, 15mL); 
      patients randomised to the placebo group will be injected in an identical manner 
      with a saline solution. The primary outcome is the 40-item quality of recovery 
      questionnaire score at 24 h after surgery. In addition, comparisons between 
      groups will be made for a 24-h opioid usage and length of hospital stay. Neck 
      pain intensity will be quantified using the numeric rating scale at 1, 3, 6 and 
      at 24 h postoperatively. Incidence of nausea, vomiting, dysphagia or hoarseness 
      in the first 24 h after surgery will also be measured. DISCUSSION: By conducting 
      a blinded placebo trial, we aim to control for the bias inherently associated 
      with a tangible medical intervention and show the true treatment effect of SCPB 
      in ACSS. A statistically significant result will indicate an overall improved 
      quality of recovery for patients; alternatively, if no benefit is shown, this 
      trial will provide evidence that this intervention is unnecessary. TRIAL 
      REGISTRATION: ClinicalTrials.gov ACTRN12619000028101. Prospectively registered on 
      11 January 2019 with Australia New Zealand Clinical Trials Registry.
FAU - Mulcahy, Michael J
AU  - Mulcahy MJ
AUID- ORCID: 0000-0001-9432-5516
AD  - Department of Neurosurgery, Nepean Public Hospital, Sydney, Australia. 
      mmulcahy@mqneurosurgery.com.
AD  - Macquarie Neurosurgery, Suite 201, 2 Technology Place, Sydney, Australia. 
      mmulcahy@mqneurosurgery.com.
FAU - Elalingam, Thananchayan
AU  - Elalingam T
AD  - Department of Clinical Medicine, Faculty of Medicine and Health Sciences, 
      Macquarie University, Sydney, Australia.
FAU - Jang, Kevin
AU  - Jang K
AD  - Department of Neurosurgery, Nepean Public Hospital, Sydney, Australia.
FAU - D'Souza, Mario
AU  - D'Souza M
AD  - Central Clinical School, University of Sydney, Sydney, Australia.
FAU - Tait, Matthew
AU  - Tait M
AD  - Department of Neurosurgery, Nepean Public Hospital, Sydney, Australia.
AD  - Macquarie Neurosurgery, Suite 201, 2 Technology Place, Sydney, Australia.
LA  - eng
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20210629
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
RN  - 0 (Anesthetics, Local)
SB  - IM
MH  - Anesthetics, Local
MH  - *Cervical Plexus Block
MH  - Cervical Vertebrae/diagnostic imaging/surgery
MH  - Double-Blind Method
MH  - Humans
MH  - Multicenter Studies as Topic
MH  - *Nerve Block
MH  - Pain, Postoperative/diagnosis/etiology/prevention & control
MH  - Prospective Studies
MH  - Randomized Controlled Trials as Topic
PMC - PMC8244165
OTO - NOTNLM
OT  - Cervical spine surgery
OT  - Placebo
OT  - Randomised controlled trial
OT  - Superficial cervical plexus
COIS- The authors declare they have no competing interests.
EDAT- 2021/07/01 06:00
MHDA- 2021/07/02 06:00
PMCR- 2021/06/29
CRDT- 2021/06/30 05:41
PHST- 2020/08/21 00:00 [received]
PHST- 2021/06/15 00:00 [accepted]
PHST- 2021/06/30 05:41 [entrez]
PHST- 2021/07/01 06:00 [pubmed]
PHST- 2021/07/02 06:00 [medline]
PHST- 2021/06/29 00:00 [pmc-release]
AID - 10.1186/s13063-021-05377-4 [pii]
AID - 5377 [pii]
AID - 10.1186/s13063-021-05377-4 [doi]
PST - epublish
SO  - Trials. 2021 Jun 29;22(1):424. doi: 10.1186/s13063-021-05377-4.