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Ketamine Clinical Trials


Postoperative analgesic efficacy of ketamine added to bupivacaine in ultrasound guided transversus abdominis plane block for laparoscopic cholecystectomy


To see complete record on anzctr.org.au, please visit this link

Id: ACTRN12616001708448

Organisation Name: Derya Karasu

Overal Status: Completed

Start Date: 26/12/2016

Brief Summary: Purpose: To study postoperative analgesic efficacy of ketamine added to bupivacaine in ultrasound guided transversus abdominis plane block for laparoscopic cholecystectomy.

Methods: In this study the patients who can speak Turkish and who have chololithiasis and planned elective laporoscophic cholecistectomy surgery, aged between 18-75 years with ASA (American Society of Anesthesiologist) Score I-II were included. We excluded patients with blood coagulation pathologies, allergies against local anaesthetics , inability to understand the study protocol, body mass index greater than thirty or infection on the block area.

After induction of anaesthesia, anaesthetists placed the bilateral transversus abdominis plane block after visualising with an ultrasound scan and then the operation was allowed.
The patients divided into two groups :
Group I (n=60): control group. 1mg/kg Bupivacaine (Marcaine (R) AstraZeneca: Istanbul, Turkey)+ Saline 0.9% (Izotonik sodyum klorur solusyonu (R) (Eczacibasi: Istanbul, Turkey) ( total 40ml).
Group II (n=60): 1mg/kg Bupivacaine (Marcaine (R) AstraZeneca: Istanbul, Turkey)+ 0.5 mg/kg ketamine (Ketalar (R) Pfizer: Istanbul, Turkey)+ Saline 0.9%(Izotonik sodyum klorur solusyonu (R) (Eczacibasi: Istanbul, Turkey) (total 40ml).

After the operation, to obtain minimum level of pain, patients controlled analgesia pump was applied via intravenous way to the patients. Then the level of pain was observed through the visual analog scale at 0-2-4-8-12-24h postoperatively both while coughing and at rest.

When the pain level is higher than three (0=no pain; 10=severe pain), the patient can use the patient controlled analgesia pump. If the pain still exist, additional analgesic was applied and the number of additional analgesic will be recorded accordingly.Results: 108 patients completed the study: 53 in Group I and 55 in Group II. For Group II, postoperatively at 0, 2, 4 and 24. hours VAS scores at rest and 0, 2, 4, 12 and 24 hours dynamic VAS scores were significantly lower than Group I (p<0.05).Moreover, the time to first analgesic requirement was longer significantly than Group I (p<0.0001).We couldn’t find any significant difference between the groups in terms of the total tramadol consumption.
Conclusions: We concluded that TAP block with bupivacaine and ketamine combination increases the time until the first request for rescue analgesic and it provides effective analgesia on postoperative period after laparoscopic cholecystectomy.

Countries:
  • Turkey
  • Bursa


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