Determine the effectiveness of post-operative pain management of ultrasound guided transversus abdominis plane block vs open internal transversus abdominis plane block following abdominal hysterectomy a randomized controlled study

Abstract

INTERVENTION: ‐ 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 r CONDITION: Pain management folllowing surgery PRIMARY OUTCOME: 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: 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. ]; 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.