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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 -

SLCTR Registration Number

SLCTR/2018/034


Date of Registration

25 Oct 2018

The date of last modification

Nov 05, 2018



Application Summary


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 of 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


Trial Details


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


Assignment

Parallel


Purpose

Supportive care


Purpose

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

  1. history of drug allergy to local anesthetic agents
  2. local skin abnormalities at the site of introducing the TAP block like burned skin, local infection and inflammatory conditions
  3. stage 3-4 endometriosis
  4. pelvic inflammatory diseases
  5. malignant conditions
  6. patients who have diabetes


Primary outcome(s)

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.


Primary outcome(s) - Time of assessment(s)

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

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


Secondary outcome(s) - Time of assessment(s)

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


Recruitment status

Pending


State of ethics review approval

Ethical approval has obtained from the Ethical Review Committee, Teaching hospital, Kandy and faculty of medical sciences, university of Sri Jayawardenepura


Funding source

None



Contact & Sponsor Information


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


Primary study sponsor/organization

Teaching Hospital Kandy, Sri Lanka.

William Gopallawa Mawatha, Kandy, Sri Lanka.
Tel : +94812222261


Secondary study sponsor (If any)

None