Home » Trials » SLCTR/2018/034
Determining The Effectiveness of Post-Operative Pain Management of Ultrasound Guided Transversus Abdominis Plane(TAP) Block Vs Open Internal TAP Block following Abdominal Hysterectomies; A Randomized Controlled Study
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SLCTR Registration Number
SLCTR/2018/034
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Determining The Effectiveness of Post-Operative Pain Management of Ultrasound Guided Transversus Abdominis Plane(TAP) Block Vs Open Internal TAP Block following Abdominal Hysterectomies; A Randomized Controlled Study
Public Title of Trial
Determining The Effectiveness of Post-Operative Pain Management of Ultrasound Guided Transversus Abdominis Plane(TAP) Block Vs Open Internal TAP Block following Abdominal Hysterectomies; A Randomized Controlled Study
Disease or Health Condition(s) Studied
Pain management folllowing surgery
Scientific Acronym
None
Public Acronym
None
Brief title
Comparing ultrasound guided veses internal TAP block
Universal Trial Number
U1111-1220-9596
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
Is ultrasound guided TAP block effective compared to open internal TAP block following abdominal hysterectomy.
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Supportive care
Study Phase
Phase 3
Intervention(s) planned
Study setting - Study will be conducted at ward 05, teaching hospital Kandy, Sri Lanka
Randomization - Block randomization will be carried out following making of computer generated random numbers. This is a three arm study, two treatment arms and one placebo arm. 2 patients (m) per each treatment/placebo group will be allocated within each block of size 6 (3m). There are 11(B) blocks with a total sample size of 66(N= 3mB= 3X2X11). Block of size 6 is expected to collect over 1 week within 1-3 clinic dates.
Allocation concealment - the interventions concealed by using sealed envelopes.
Intervention - One arm of study will receive ultrasound guided TAP block immediately following closure of the skin before recovery of patients following skin preparation using betadine. Other arm will receive internal TAP block before closing of the rectus sheath. For both types of TAP blocks we will use a 20 ml syringe with 18G needle and as the anaesthetic agent we will use 20 ml 0.25% bupivacaine for each side followed by a re-aspiration technique to prevent vascular injury and then the bupivacaine will be injected slowly into the appropriate plane.
Control - All 3 arms will be injected with pethidine 50-75 mg as a single dose immediately following operation (according to the body weight).
Rescue analgesia will be offered to all participants. Simple analgesics like paracetamol and NSAIDS will be offered to all participant freely on demand and those data also will be documented in data collection form.
Management of complications- Complications of TAP block include toxicity to the local anesthetic agent and accidental intravascular injection of the anesthetic agent. Safety monitoring will be done intraoperative and up to one year post operatively by both the surgical and anaesthetic team. All patients will be followed up for the occurrence of above mentioned complications by the adverse effect monitoring committee. Study related surgical injuries will be treated by the attending gynaecological team with vascular surgical support Intraoperative and post-operative drug related complications will be managed by the anaesthetic team.
9- Blinding- This is a double blinded study. Randomization will be done by a clinic nurse. She will recruit 6 patients, 2 per each arm, whom decided for abdominal hysterectomy per each clinic day by block randomization using sealed envelopes. Interventions will be done by a SHO/Registrar of gynaecology and MO/ Registrar of anesthesiology. Primary investigator will not take part in interventions, closure of abdomen and final analysis. Demonstrator of the department will be appointed as outcome assessor as well as data analyser. One arm of study of 22 patients will receive ultrasound guided TAP block immediately following closure of the skin before recovery of patients. There won’t be any external marks in all three arms of the study and therefore patients and the primary investigator will be blinded until end of the data collection.
Inclusion criteria
patients who are scheduled and admitted for abdominal hysterectomy 1. via supra pubic transverse incision 2. aged between 40-60 3. American society of anesthesiology physical status classification system grade I-II which includes normal healthy patients, patients with mild systemic diseases like well controlled hypertension, diabetes and mild lung diseases.
Exclusion criteria
Primary outcome(s)
1.
Primary outcome measure will be requirement for additional opioid analgesia during post- operative period that will be given according to patients’ demand. Intramuscular pethidine will be offered according to requirement with minimal of 6 hours apart and total doses and the time will be marked. Other than pethidine, tramadol and panadine will be offered secondarily if request by patients and will be document in data collection form. |
[ Patients will be assessed at 2, 6, 12, 24, 36 and 48 hour intervals. Post-operative Pethidine requirement in 12, 24, 48 hours will be calculated and analyzed. ] |
Secondary outcome(s)
1.
Secondary outcome measures will be patient centred assessment of post-operative pain which will be assessed using a visual analogue scale (VAS) both at rest and while flexing her knee joint. VAS is scaled from 0 to 10 where no pain is 0 and maximum painis10 that would be marked by patients at different time periods postoperatively. At the end of the procedure of both ultrasound guided and open internal TAP time will be recorded at data collection sheets. As TAP block takes 45 minutes to have its action patients will be assessed at 2, 6, 12, 24, 36 and 48 hour intervals since the time of ending the TAP block |
[ Patients will be assessed at 2, 6, 12, 24, 36 and 48 hour intervals. ] |
Target number/sample size
66 (22 in each arm, 3 arms)
Countries of recruitment
Sri Lanka
Anticipated start date
2018-10-29
Anticipated end date
2018-12-31
Date of first enrollment
2018-11-01
Date of study completion
Recruitment status
Recruiting
Funding source
None (Investigator funded)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2018-08-23
Approval number
26/18
Details of Ethics Review Committee
Name: | Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura |
Institutional Address: | Gangodawila, Nugegoda Sri Lanka |
Telephone: | +94-112758000 (Extension: 4075) |
Email: | erc.fms.usjp@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. R P J Sumanathissa
Registrar in Obstetrics and Gynarcology
Castle Street Hospital for Women, Colombo
Mob: 0775404921
prabathrandombage@gmail.com
Contact Person for Public Queries
Dr. R P J Sumanathissa
Registrar in Obstetrics and Gynarcology
Castle Street Hospital for Women, Colombo
Mob: 0775404921
prabathrandombage@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Applicable
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results