Clinical trial NCT03437187: The Beneficial Effect of Quadratus Lumborum Block After Laparoscopic Cholecystectomy
Official title: The Beneficial Effect of Quadratus Lumborum Block After Laparoscopic Cholecystectomy in Day-Case Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystectomy
Quadratus Lumborum Block
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

* Oral paracetamol and codeine-fixed combination up to 1000 mg and 60 mg, respectively, every 6 h
* In case of insufficient analgesia, as judged by the patient, oxycodon 1 - 5 mg IV.
* When nausea and vomiting occur postoperatively, ondansetron 4 mg IV administers as the drug of first choice followed by droperidol 0,625 mg IV if the nausea/vomiting persists.

Collected data:

* Postoperative pain at rest and during activity evaluates by a 0 - 10 scale (NRS) on admission to recovery, and every hour until discharge.
* Rescue analgesic consumption during 0 to 4, 4 to 24 and 24 to 48 h.
* Nausea and vomiting record by the same 0 - 3 scale (none, slight, moderate, strong) during recovery
* Time of postoperative mobilization with corresponding pain score.
* Time of discharge-to-home readiness according to standard criteria, including stable vital signs, no bleeding from the surgical site, ability to void, absence of excessive nausea and pain, and ability to dress and walk without support.
* Side effects including nausea and/or vomiting (0 to 4, 4 to 24, and 24 to 48 h), and other side effects and symptoms of LA (Local Anaesthetic) toxicity.

Telephone interview at 24 h and 48 h

Eligibility criteria: Inclusion Criteria:

* Age 18-80 Years
* BMI 20-35
* ASA physical status I-II

Exclusion Criteria:

* Allergy to local anaesthetics
* Chronic pain requiring opioid analgesics
* Patients with atrioventricular block II
* Patients treated with class III antiarrhythmics
* Patients with severe renal and/or hepatic disease
* A coagulation disorder
* An infection at the LA injection place

Primary outcomes:
measure: Use of analgesics -"change" is being assessed
timeFrame: 1 week (0-4hrs) (4-24hrs) (24-48hrs)
Secondary outcomes:
measure: Pain at the incision site - "change" is being assessed
timeFrame: 48 hours (0-4hrs) (4-24hrs) (24-48hrs)
measure: Deep pain and pain on coughing - "change" is being assessed
timeFrame: 48 hours (0-4hrs) (4-24hrs) (24-48hrs)
measure: Nonsteroidal anti-inflammatory drug consumption - "change" is being assessed
timeFrame: 48 hours(0-4hrs) (4-24hrs) (24-48hrs)
measure: Postoperative nausea and vomiting - "change" is being assessed
timeFrame: 48 hours(0-4hrs) (4-24hrs) (24-48hrs)
Other outcomes:
Locations:
city: Grålum
country: Norway
facility: Ostfold Hospital Trust, Moss
state: Ostfold
Study officials:
References:
citation: Borglum J, Gogenur I, Bendtsen TF. Abdominal wall blocks in adults. Curr Opin Anaesthesiol. 2016 Oct;29(5):638-43. doi: 10.1097/ACO.0000000000000378.
citation: Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.
citation: El-Dawlatly AA, Turkistani A, Kettner SC, Machata AM, Delvi MB, Thallaj A, Kapral S, Marhofer P. Ultrasound-guided transversus abdominis plane block: description of a new technique and comparison with conventional systemic analgesia during laparoscopic cholecystectomy. Br J Anaesth. 2009 Jun;102(6):763-7. doi: 10.1093/bja/aep067. Epub 2009 Apr 17.
citation: Murouchi T, Iwasaki S, Yamakage M. Quadratus Lumborum Block: Analgesic Effects and Chronological Ropivacaine Concentrations After Laparoscopic Surgery. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):146-50. doi: 10.1097/AAP.0000000000000349.
citation: Petersen PL, Stjernholm P, Kristiansen VB, Torup H, Hansen EG, Mitchell AU, Moeller A, Rosenberg J, Dahl JB, Mathiesen O. The beneficial effect of transversus abdominis plane block after laparoscopic cholecystectomy in day-case surgery: a randomized clinical trial. Anesth Analg. 2012 Sep;115(3):527-33. doi: 10.1213/ANE.0b013e318261f16e. Epub 2012 Jul 4.
citation: Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.