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.: PACTR202008898409782 Date of Approval: 25/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Post TAP for visceral pain
Official scientific title Posterior transversus abdominis plane block, for abdominal surgeries, a visceral pain targeted study
Brief summary describing the background and objectives of the trial Pain after abdominal surgeries has both somatic and visceral component. Somatic blockade of the intercostal nerve by transversus abdominus plane block is extensively investigated and is used as a part of multimodal analgesia after open and laparoscopic abdominal surgeries. However, the famous block lacks evidence supporting its ability to block the sympathetic nerve fibers carrying visceral pain component form intra-abdominal structures(Arı et al. 2017; Kim et al. 2001; Sikandar and Dickenson 2012). Visceral pain reported that after laparoscopic cholecystectomy predominates in the first 24 h but subsides from a peak soon after operation. Visceral pain is frequently accompanied by nausea, vomiting, and sweating. Pain, particularly if severe, is often referred to distant somatic superficial sites. Treatment recommendations for visceral pain have been the same for somatic pain, yet visceral pain processing is distinctly different from somatic nociception and as a result should perhaps be treated differently from somatic pain.(Koptan, Soliman, and Sherif 2015; Ortiz and Wofford 2017; Serifsoy et al. 2020) Local anesthetic injected between the transversus abdominis muscle and its deep investing transversalis fascia will spread over the inner surface of the quadratus lumborum muscle and block the proximal portions of the T12 and L1 nerves. This will produce block of both the anterior and the lateral branches of these nerves. This transversalis fascia block (TFP) targets these nerves anatomically between the lumbar plexus block and the TAP block (Cardoso et al. 2018; Dyer et al. 2016; Hebbard 2009; Nagpal et al. 2019). Few studies have evaluated the visceral pain component after laparoscopic abdominal surgeries. The characteristic features of visceral pain can be quietly annoying and agonizing to patients especially when the somatic portion of pain is adequately covered by somatic blocks(Davis 2012; Kraychete et al. 2017). Very few studies have evaluated the visceral pain component in laparoscopic surgery. Aim of the study In this study, Posterior TAP block will be assessed regarding its sympathetic block effect and analgesia of visceral pain indicated by patient reporting of colicky and deep pain.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PostTAP
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/09/2020
Actual trial start date 01/10/2020
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Recruiting
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Posterior TAP group 50 mg bupivacaine during Surgery and in the first postoperative day the probe will be located across the posterior axillary area and local anesthetic injected in the posterior junction of the transverse abdominal plane and the anterolateral border of the quadratus lumborum muscle. The success of the injection will be confirmed by the spread of local anesthetic under fascia. 25
Control Group Lateral TAP 50 mg bupivacaine during surgery and in the first postoperative day the probe will be located across the posterior axillary area and local anesthetic injected in the posterior junction of the transverse abdominal plane and the anterolateral border of the quadratus lumborum muscle. The success of the injection will be confirmed by the spread of local anesthetic under fascia. 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The study population will include all patients scheduled for laparoscopic abdominal surgeries, with age range from 18- to 45-year, American Society of Anesthesiologists (ASA) class I-II. Exclusion criteria will include: lack of written consent, drug abuse, allergic reactions to local anesthetics, BMI >40, and coagulopathies. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 16/08/2020 Institutional Review board Mansoura university
Ethics Committee Address
Street address City Postal code Country
El Gomhoreya street Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Time for rescue analgesia administration in minutes the first postoperative day
Primary Outcome Rescue analgesia or first postoperative analgesia (Diclofenac 75mg intravenously) was considered when VAS ≥40 was observed. the first postoperative day
Secondary Outcome The total dose of analgesic required in milligrams the first postoperative day
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University hospitals Elgomhoreya Mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alrefaey Kandeel Elgomhoreya Mansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura University Elgomhoreya Mansoura Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alrefaey alrefaey refa3ey2@yahoo.com +201064203475 Elgomhoreya
City Postal code Country Position/Affiliation
Mansoura Egypt Mansoura university
Role Name Email Phone Street address
Scientific Enquiries Alrefaey Alrefaey refa3ey2@yahoo.com +201064203475 Elgomhoreya
City Postal code Country Position/Affiliation
Mansoura Egypt Mansoura University
Role Name Email Phone Street address
Public Enquiries Alrefaey Alrefaey refa3ey2@yahoo.com +201064203475 Geihan street
City Postal code Country Position/Affiliation
Mansoura Egypt Mansoura university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes study protocol , results tables and statistical plan will be shared t Statistical Analysis Plan,Study Protocol within 6 months from last recuitment any researcher or institutional request covered by ethical committee or research review board
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information