Ostfold Hospital Trust, Moss
Grålum, Østfold fylke, 1714, Norway
NCT Number: NCT03437187
The enhanced recovery after surgery and laparoscopic approach is essential after day-case surgery. The patients want to go home early without pain and nausea, and the hospitals need the post-operative capacity for more patients. Many patients have pains, nausea and vomiting postoperatively. Postoperative pain is an expected but undesirable effect after an operation. The aim of the study is to find out if a bilateral quadratus lumborum block has a beneficial effect after a cholecystectomy.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Grålum, Østfold fylke, 1714, Norway
QLB (quadratus lumborum block) is a recommended multimodal method of reducing postoperative pain in laparoscopic and open surgery. Quadratus lumborum block for postoperative pain after caesarean section 2015). Transversus abdominis plane (TAP) block seems to be feasible and effective in postoperative pain control without increasing morbidity in cholecystectomy. QLB is also performed as one of the perioperative pain management procedures in abdominal surgery. It is regarded as an effective analgesic tool The dermatomal effects of QLB reach higher than the TAP block and might explain the better effect of the QLB than TAP blocks on postoperative pain after caesarean delivery. A randomized double blinded clinical trial with TAP block in patients scheduled for cholecystectomy is performed, but there is no good data for the QLB. For this study the investigators standardize the type of surgery to be laparoscopic day-case cholecystectomy, and we use the anterior (transmuscular) QLB.
Power and Sample Size Calculator The number of patients required for the study was calculated on the basis of opioid consumption. The investigators are interested in a reduction by 20% in the group given QLB. Assuming α=0,05, the calculation shows a need of 69 patients (23 in each group) to achieve a power of 80% (β=0.2).
75 adult patients scheduled for cholecystectomy have to be included. Subcutaneous wound infiltration at the end of surgery in all patients with ropivacaine 2 mg/ml, 10 ml. Maximum allowed dosis is 3 mg/kg BW (BodyWeight). Dosis reduction if BW<70 kg. All three groups receive necessary analgesics oral or parenteral.
Premedication: Paracetamol 2g and Diklofenak 100 mg
General anesthesia: TCI (Target Control of Infusion): Propofol and Remifentanil, Ondansetron 4 mg and Decadron 8 mg iv preoperatively. Oxycodon 5 mg iv at the end of the procedure.
Surgical procedure: Cholecystectomy, laparoscopic and day-case.
Postoperatively:
Collected data:
Telephone interview at 24 h and 48 h
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Laparoscopic technique
Other names: Quadratus lumborum block with Naropin, Quadratus lumborum block with Nacl, Traditional analgesics
Time frame: 1 week (0-4hrs) (4-24hrs) (24-48hrs)
Amount of analgesics used postoperative
Time frame: 48 hours (0-4hrs) (4-24hrs) (24-48hrs)
NRS (Numeric Rating Scale; 0 - 10) 0 = no pain, 10 = severe pain
Time frame: 48 hours (0-4hrs) (4-24hrs) (24-48hrs)
NRS (Numeric Rating Scale; 0 - 10) 0 = no pain, 10 = severe pain
Time frame: 48 hours(0-4hrs) (4-24hrs) (24-48hrs)
Amount of different medicaments in mg
Time frame: 48 hours(0-4hrs) (4-24hrs) (24-48hrs)
0-3 score where 0=none, 1=little nausea, 2=can not eat, 3=vomiting
Ostfold Hospital Trust
Other
The Beneficial Effect of Quadratus Lumborum Block After Laparoscopic Cholecystectomy in Day-Case Surgery: A Randomized Controlled Trial
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