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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001708448
• Date of registration: 13/12/2016
• Prospective Registration: Yes
• Primary sponsor: Derya Karasu
• Public title: Postoperative analgesic efficacy of ketamine added to bupivacaine in ultrasound guided transversus abdominis plane block for laparoscopic cholecystectomy
• Scientific title: Postoperative analgesic efficacy of ketamine added to bupivacaine in ultrasound guided transversus abdominis plane block for laparoscopic cholecystectomy
• Date of first enrolment: 26/12/2016
• Target sample size: 120
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616001708448.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Type of endpoint: Safety/efficacy;
• Phase: Phase 4

Countries of recruitment

Turkey

Contacts

• Name: Dr Derya Karasu

• Name: Dr Derya Karasu

Key inclusion & exclusion criteria

Inclusion criteria: elective surgery
laparoscopic cholecystectomy
ASA (American Society of Anesthesiologist) Score) I-II
who can talk turkish language.
Exclusion criteria: blood coagulation pathologies
allergies against local anaesthetics
inability to understand the study protocol
body mass index >30
infection on the block area



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Surgery - Other surgery

Anaesthesiology - Pain management

Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

postoperative analgesia;
postoperative analgesia

Intervention(s)

The patients ' demographic data was recorded. The patients will be divided into two groups. Patients distributed to groups with closed envelope technique
Group I (n=60): control group.
All transversus abdominis plane blocks were performed under ultrasound guidance after induction of anesthesia, before beginning of surgery by the same anesthesiologist who performed block at least 20 times. 1mg/kg Bupivacaine (Marcaine (R) AstraZeneca: Istanbul, Turkey)+ Saline 0.9% (Izotonik sodyum klorur (R) (Eczacibasi: Istanbul, Turkey) ( total 40ml) injected in the transversus abdominis fascial plane under direct visualization.
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 (R) (Eczacibasi: Istanbul, Turkey) (total 40ml).

The patients received patient-controlled intravenous analgesia (PCA) with 90 ml normal saline + 500 mg tramadol (Tramosel (R), Haver, Istanbul, Turkey) for postoperative pain management (bolus dose: 5 ml, lockout period: 20 minutes,without loading dose). All patients received intravenous analgesia via the same type of PCA (Patient Controlled Analgesia) device for 24 hours period.
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 will be applied by the same anesthesiologist who assessed outcomes and the number of additional analgesic was recorded..

Primary Outcome(s)

time of first analgesic requirement
this information is taken from patients themselves[at any time in the 24 hours]

Pain, assessed by visual analogue scale at rest and during movement.[at 0-2-4-8-12-24. hours]

rate of analgesic consumption in the 24 hours after surgery

Datas of analgesic agent consumption are assessed by review of medical records. Analgesic consumption will be calculated by the total amount of analgesic agents spent on Patient-controlled analgesia (PCA)[24 hours post surgery]

Secondary Outcome(s)

Adverse effects (itching, allergies, nausea, vomiting, urinary retention, constipation, respiratory depression, bradycardia, hypotension, dizziness ,hallucination i.e.)[during intraoperative process and 24 hours post surgery

Adverse events were recorded. If adverse events were recognized, They were evaluated according to Common Terminology Criteria for Adverse Events (CTC-AE) ver. 4.0.
This adverse events listed are assessed as recorded by treating clinician in the medical records]

Secondary ID(s)

nil known

Source(s) of Monetary Support

Derya Karasu

Demet Ozer

Secondary Sponsor(s)

Canan Yilmaz

Ethics review

Status: Approved
Approval date:
Contact:

Yuksek Ihtisas Training and Education Hospital Clinical Researc Ethics Committee