Tap Block vs Peritoneal Infiltration After Major Gynecological Surgeries
Condition: Pain, Acute
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      It is a randomized controlled trial to determine the total tramadol consumption after major
      gynecological studies. Intervention groups include TAP block or local infiltration by the
      surgeon. These will be compared to a control group. Total tramadol consumption will be
      calculated and therefore pain control will be assessed.
    

Detailed description: 
      All patients will receive standardized general anesthetic with standard monitoring.
      Anesthesia will be induced with intravenous (IV) tramadol (1milligram/kg), propofol (2 mg/kg)
      and atracurium 0.5mg/kg. Anaesthesia will be maintained with oxygen/air (40:60) with one
      MAC(Minimum Alveolar Concentration) of isoflurane.

      TAP block will be performed for Group T patients before surgical incision with the help of an
      ultrasound and will be performed by two of the anesthesiologists who are part of this study.
      The study drug for the TAP block will be two syringes of 20 ml containing bupivacaine 0.25%
      with no other additives. For the infiltration group I, a 50ml syringe will contain 25ml of
      0.5% Bupivacaine and 25ml of 5mics/ml epinephrine. These solutions will be made there and
      then by the anesthesiologist and the drugs for these solutions will be provided by the
      clinical trial unit. Allocation to group T, I and C will be according to the randomization
      block explained earlier. For group T, the US-guided TAP block technique will be similar to
      the method described by Hebbard and colleagues; (21) an ultrasound linear probe will be
      positioned in the mid-axillary line in the axial plane half-way between the iliac crest and
      the costal margin. Transversus abdominal plain will be located under ultrasound guidance. One
      ml test injection of the study solution will be permitted to confirm needle location. A total
      of 20ml of study solution will be injected on each side after aspiration to avoid
      intravascular placement. Surgical incision will be given after 20 minutes of TAP. Additional
      doses of Tramadol 10mg IV stat will be given on need basis (Rise of heart rate and blood
      pressure more than 20 % of baseline).

      Towards the end of surgery, 50 ml of solution prepared by the anesthesiologist will be used
      for Group I. 50ml of 0.25% Bupivicaine with epinephrine will be poured into a sterile galley
      pot, from which the surgeon will draw up the solution. The surgeon will be asked to spray
      10ml of this solution on to the pouch of Douglas, 10ml in the peritoneum, 10ml in the rectus
      sheath and 20ml in the skin.

      The amount of Bupivicaine used for group I and T is less than the maximum safe dose which is
      2.5mg per kg. Minimal side effects are reported using an ultrasound guided TAP block
      technique(22). If an immediate side effect is noted while performing the technique, treatment
      will be administered and the patient will be withdrawn from the study.

      The control group (C) will receive the standard anesthesia and analgesia as mentioned above
      without any nerve block technique.

      Prophylactic antiemetics in the form of ondansetron 4mg IV stat block and IV paracetamol
      15mg/kg will be administered 30 minutes before the end of surgery and diclofenac 100 mg
      suppository will be administered at the end of surgery.

      Routine monitoring of intraoperative blood pressures, heart rates, (base line, induction,
      surgical incision and at 10 minutes interval) administered fluid and drugs, surgical time and
      estimated blood loss will be recorded on intraoperative chart.

      After completion of the surgical procedure, patients will be transferred to the post
      anesthesia care unit (PACU). A standardized postoperative analgesic regimen, consisting of
      regular rectal diclofenac 100 mg every 12 hours and oral paracetamol 1000mg every 6 hrs
      combined with IV PCIA Tramadol (no baseline infusion, demand bolus dose 15 mg, lock out 8
      min), will be commenced on admission to the PACU for all 3 groups. Total tramadol consumption
      and side effects will be calculated at end of 12 hours.
    

Intervention name(s): Transversus Abdominis Plane Block(TAP Block); Intra-peritoneal infiltration; PCIA Tramadol
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): Under ultrasound guidance, a 22 gauge stimuplex needle will be used to approach the transversus abdominis plane and 20ml of 0.25% Bupivicaine will be infiltrated into the TAP space. This procedure will be performed on either sides once anesthesia is induced.; Before skin closure, the surgeon will infiltrate the peritoneal cavity using a mixture of bupivicaine and epinephrine; All patients will be given patient controlled intravenous analgesia using Tramadol as the drug
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: TAP block; Local infiltration; Tramadol; Gynecological surgery; Pain control