Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202001579588451 Date of Approval: 13/01/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of bilateral superficial cervical plexus block for thyroid surgery under general anesthesia
Official scientific title Analgesic Efficacy of bilateral superficial cervical plexus block for thyroid surgery under general anesthesia; a prospective cohort study
Brief summary describing the background and objectives of the trial Uses of simple analgesics were found insufficient to manage pain after thyroid surgery. We hypothesized that using bilateral superficial cervical plexus block (BSCPB) might influence the pattern of immediate postoperative pain and analgesic consumption. The general objective of the study was to assess the analgesic efficacy of bilateral superficial plexus block for thyroid surgery under general anesthesia.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/02/2016
Actual trial start date 01/02/2016
Anticipated date of last follow up 30/05/2016
Actual Last follow-up date 30/05/2016
Anticipated target sample size (number of participants) 74
Actual target sample size (number of participants) 74
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Bilateral superficial cervical plexus block 10 ml of 0.25% bupivacaine along the posterior borders of the sternocleidomastoid muscles on each side of the neck immediately before skin incision. Follow-up continued until the first 24th postoperative hour. Bilateral superficial cervical plexus block is one of the commonly used analgesic techniques for thyroid surgery. It blocks nerves arise from the cervical plexus which are the lesser occipital, greater auricular, transverse cervical, and supraclavicular nerves. The block usually performed by depositing local anesthetic solutions subcutaneously along the posterior borders of sternocleidomastoid muscles on each side. compared to the deep cervical plexus block, the superficial technique is associated with lesser rates of complications. 37
Control Group No intervention done None Follow-up continued until the first 24th postoperative hour. None 37 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All adults (18+) ASA I and ASA II patients who undergone thyroidectomy at the hospital during the study period were included in the study. Patients who have refused to participate, Allergic history for local anesthetics, Retro-sternal goiter, Altered anatomical landmarks, Coagulation abnormality and Other contraindications for the block were excluded 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 66 Year(s) Both
All adult (18+) ASA I and II patients who undergone thyroidectomy at the hospital during the study period were included in the study. Patients who have refused to participate, allergic history for local anesthetics, retro-sternal goiter, altered anatomical landmarks, coagulation abnormality and other contraindications for the block were excluded Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 66 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/01/2016 Ethical review committee of department of anesthesia college of medicine and health sciences university of Gondar
Ethics Committee Address
Street address City Postal code Country
Atse Bakafa Street Gondar 251196 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain severity on a numerical rating scale 0, 2nd, 6th, 12th and 24th postoperative hours
Secondary Outcome Analgesic consumption 0, 2nd, 6th, 12th and 24th postoperative hours
Secondary Outcome Time to the first analgesic requirement 0, 2nd, 6th, 12th, and 24th postoperative hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Gondar Hospital Atse Bakafa Street Gondar Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Yophtahe B. Woldegerima Amare G. Hailekiros Girmay L. Fitiwi Atse Bakafa Street Gondar 251196 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Anesthesia College of Medicine and Health Sciences University of Gondar Atse Bakafa Street Gondar Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Bethelihem Habtu Bezawit Haile and Biresaw Ayen were data collectors Atse Bakafa Street Gondar Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yophtahe Woldegerima yophtii@gmail.com +251912494282 Atse Bakafa Street
City Postal code Country Position/Affiliation
Gondar Ethiopia Lecturer at University of Gondar
Role Name Email Phone Street address
Scientific Enquiries Amare Hailekiros amaretome22@gmail.com +251963734243 Atse Bakafa Street
City Postal code Country Position/Affiliation
Gondar Ethiopia Assistant Professor of Anesthesia and Head of the Department
Role Name Email Phone Street address
Public Enquiries Girmay Fitiwi tsagir.fitiwi@gmail.com +251985031522 Atse Bakafa Street
City Postal code Country Position/Affiliation
Gondar Ethiopia Assistant Professor of Anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data (IDP) is available and can be presented by the principal investigator upon reasonable request. Informed Consent Form,Study Protocol 12 months Anyone who is concerned can request to access individual participant data (IPD). The investigators will discuss and decide on the appropriateness of the request. Upon appropriate request, the data will be presented.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes Demographic, anthropometric and clinical characteristics of participants A total of 74 patients (34 in each group) were involved. The demographic, anthropometric and clinical characteristics of participants were found comparable between the groups [Table 1]. Sub-total and near-total thyroidectomies were the leading types of thyroid surgery in the block group and non-block group respectively. The length of incision was 9.2 ± 2.8 vs 9.1 ± 2.1 in the block group and non-block group respectively and no statistically significant difference between the groups. Simple nodular goiter was the most frequent (22; 59.4%) diagnosis in the block group and multi-nodular goiter in the non-block group (16; 43.2%). Only 4 patients (1 in the block group and 3 in the non-block group) had undergone extended neck dissection. The use of preemptive analgesia with simple analgesics and opioids was comparable. There was no difference in the choices of induction agents. Large proportions of patients in both groups were induced with propofol (block group = 75.7% vs non-block group = 67.6%, p > 0.05) and the remaining with thiopentone. Patterns of pain and analgesic requirements At all endpoints, pain scores were significantly lower in the block group. Furthermore, the first analgesic request time was significantly longer in the block group than the non-block group [Table 2]. Total analgesic consumption in the first 24 postoperative hours was significantly reduced in the group that received BSCPB. Surprisingly, none of the patients in the block group required strong opioid analgesics. However, 24 hours of pethidine consumption was 34 ± 15.1 mg in the non-block group [Table 3]. 26/12/2019 20/01/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://docs.google.com/uc?export=download&id=1mXyiykV7M_dkMpOOZ8PCudQzahMAmjNF
Changes to trial information