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.: PACTR202002616299138 Date of Approval: 10/02/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison of Spinal Morphine and Transverse Abdominis Plane Block for Postoperative Pain Management in Patients Undergone Cesarean Section Under Spinal Anesthesia at Hawassa University Comphrensive and Specialized Hospital Ethiopia 2019: Randomized control trial
Official scientific title Comparison of Spinal Morphine and Transverse Abdominis Plane Block for Postoperative Pain Management in Patients Undergone Cesarean Section Under Spinal Anesthesia : Randomized control trial
Brief summary describing the background and objectives of the trial Caesarean Section (CS) has been one of the most frequently performed major surgical interventions, and causes severe postoperative pain and subsequent manipulation performed through Pfannenstiel incision is associated commonly with significant degree of pain in the postoperative period, up to 79% of women experience pain at the incision site that can last for up to 2 months .Intrathecal opioid & abdominal field block has been investigated as effective analgesia for postoperative pain and reduce the need of systemic medications and their associated side effect, so the provision of effective post-operative analgesia is important to facilitate early mobilization of mother, infant care ,prevention of post-operative morbidity, increase patient satisfaction and decrease duration of hospital stay . The objective of this study is to compare spinal Morphine and Transverse Abdominis Plane Block for Postoperative Pain Management in patients undergone Cesarean Section under Spinal Anesthesia at Dilla university referral hospital Ethiopia 2019.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/01/2020
Actual trial start date 15/01/2020
Anticipated date of last follow up 05/05/2020
Actual Last follow-up date 10/07/2020
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 114
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
Dilla University Institutional Review Board
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 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 Spinal Morphine 0.1 mg 24 hour In spinal morphine group 0.1 mg of preservative free morphine will be prepared and simultaneously patient will be positioned on operating table and under strict aseptic technique local infiltration of the entry point using 5 ml (40 mg) off 2% plain lidocaine will be done. Spinal anesthesia will be performed by responsible anesthetist between L3-L4 interspace by using tuffers line as a landmark with a 25 gauge spinal needle then after the free flow of cerebrospinal fluid (CSF) 2.5 ml of 0.5% isobaric bupivacaine (12.5 mg) together with 0.1 mg preservative free morphine. Immediately after patient will be put on supine position and a pillow will be inserted under the right hip to prevent aortocaval compression. The level of block will be checked (alcohol drips for autonomic, pinprick for sensory & bromage scale for motor) and surgery will undergo after a sensory level of T6. 60
Control Group TAP BLOCK 20 ml 24 hour After spinal anesthesia the nerve block will be performed by one of the BSc anesthetist who is experienced and he has been managing many cesarean section and used TAP block for post-operative pain management as protocol with multimodal analgesia in obstetric by using a standard landmark technique bilaterally. 0.25% bupivacaine solution will be prepared by using 0.9% normal saline for dilution by the investigator. Landmark TAP block: Anterior superior iliac crest, latissimus dorsi muscle, and external oblique muscle Technique – single injection The patient will lie in supine position. The skin will be prepared with 0.5% chlorhexidine in 70% alcohol. Wait until the skin is dry. Then identify identified the lumbar triangle of Petit as an access point to the neurofascial plane This triangle is bounded posteriorly by the latissimus dorsi muscle, anteriorly by the external oblique, and inferiorly by the iliac crest. Then a 22G blunted needle will be advanced perpendicular to skin. As the external oblique muscle is pierced, a characteristic ‘click’ or ‘pop’ is felt and as the needle is advanced further a second ‘click’ is felt as the internal oblique muscle is pierced then after care full aspiration 20ml of 0.25% bupivacaine in injected in the facial plane. The same procedure will be performed at the contra lateral side 60 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All ASA II Age 18-45 Parturient who will undergo elective caesarean delivery Pfannenstiel incision under spinal anaesthesia • Patient refusal • ASA 3 and above • Caesarean delivery requiring epidural analgesia • Preeclamptic • Mothers with chronic pain disorder • history of benzodiazepines taking • history of opioid taking • infection at needle insertion site • coagulopathy disorder • hypovolemic patient • Allergy to local anaesthetics and morphine • Failed spinal block or difficulty • patients unable to self -report acute pain • Cognitive impairment (Dementia, Alzheimer Adult: 19 Year-44 Year 18 Year(s) 45 Year(s) Female
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 23/12/2019 Dilla University College of Health and Medicine Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Dilla Dilla 4040 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • Time to first analgesic request in minutes • Pain severity in NRS score • Total postoperative Analgesia consumption in 24 hours 2 hour
Secondary Outcome adverse effect of spinal Morphine Every two hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dilla University Referral Hospital Dilla Dilla Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Dilla University Dilla Dilla 4040 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dilla University Dilla Dilla 4040 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Semagn Mokennon Dilla Dilla 4040 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fetiya Mohammed Fetiyayemame@gmail.com +251921895794 Hawasa
City Postal code Country Position/Affiliation
Hawassa Ethiopia Hawassa University comprehensive and Specialized Hospital
Role Name Email Phone Street address
Scientific Enquiries Bedru Jemal bedruanst@gmail.com +251924415702 Dilla
City Postal code Country Position/Affiliation
Dilla Ethiopia Dilla University College of health and medicine science
Role Name Email Phone Street address
Public Enquiries semagn mokennon semmek17@gmail.com +251913864605 Dilla
City Postal code Country Position/Affiliation
Dilla Ethiopia Dilla University College of Health science and medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available Informed Consent Form,Study Protocol Six month Email
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 20/10/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 20/10/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information