The Beneficial Effect of Quadratus Lumborum Block After Laparoscopic Cholecystectomy

Cholecystectomy Clinical Trial

Official title:

The Beneficial Effect of Quadratus Lumborum Block After Laparoscopic Cholecystectomy in Day-Case Surgery: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03437187
• Other study ID #: 1812
• Status: Completed
• Phase: N/A
• Start date: January 20, 2018
• Est. completion date: February 18, 2020

Study information

• Verified date: February 2020
• Source: Ostfold Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: February 18, 2020
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholecystectomy
• Quadratus Lumborum Block

Intervention

Procedure:
• Cholecystectomy
Laparoscopic technique

Locations

Country	Name	City	State
Norway	Ostfold Hospital Trust, Moss	Grålum	Ostfold

Sponsors (1)

Lead Sponsor	Collaborator
Ostfold Hospital Trust

Country where clinical trial is conducted

Norway, 

References & Publications (6)

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. Erratum in: Reg Anesth — View Citation

Børglum J, Gögenür I, Bendtsen TF. Abdominal wall blocks in adults. Curr Opin Anaesthesiol. 2016 Oct;29(5):638-43. doi: 10.1097/ACO.0000000000000378. Review. — View 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 ch — View 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. — View 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 clini — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of analgesics -"change" is being assessed	Amount of analgesics used postoperative	1 week (0-4hrs) (4-24hrs) (24-48hrs)
Secondary	Pain at the incision site - "change" is being assessed	NRS (Numeric Rating Scale; 0 - 10) 0 = no pain, 10 = severe pain	48 hours (0-4hrs) (4-24hrs) (24-48hrs)
Secondary	Deep pain and pain on coughing - "change" is being assessed	NRS (Numeric Rating Scale; 0 - 10) 0 = no pain, 10 = severe pain	48 hours (0-4hrs) (4-24hrs) (24-48hrs)
Secondary	Nonsteroidal anti-inflammatory drug consumption - "change" is being assessed	Amount of different medicaments in mg	48 hours(0-4hrs) (4-24hrs) (24-48hrs)
Secondary	Postoperative nausea and vomiting - "change" is being assessed	0-3 score where 0=none, 1=little nausea, 2=can not eat, 3=vomiting	48 hours(0-4hrs) (4-24hrs) (24-48hrs)