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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cholecystectomy without nerve blocks | Other | Cholecystectomy, enteral and parenteral analgesics |
|
| Cholecystectomy with placebo nerve block | Placebo Comparator | Cholecystectomy, NaCl as a placebo Quadratus lumborum block |
|
| Cholecystectomy with naropin nerve block | Active Comparator | Cholecystectomy, Quadratus lumborum block with naropin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecystectomy | Procedure | Laparoscopic technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| Use of analgesics -"change" is being assessed | Amount of analgesics used postoperative | 1 week (0-4hrs) (4-24hrs) (24-48hrs) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Deep pain and pain on coughing - "change" is being assessed |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ostfold Hospital Trust, Moss | Grålum | Østfold fylke | 1714 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27429253 | Result | 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. | |
| 27755488 | Result | 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. |
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| ID | Term |
|---|---|
| D002763 | Cholecystectomy |
| D000077212 | Ropivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D000813 | Anilides |
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Information connecting the patients to the data are kept locked and will be destroyed after the end of the investigation
|
NRS (Numeric Rating Scale; 0 - 10) 0 = no pain, 10 = severe pain
| 48 hours (0-4hrs) (4-24hrs) (24-48hrs) |
| Nonsteroidal anti-inflammatory drug consumption - "change" is being assessed | Amount of different medicaments in mg | 48 hours(0-4hrs) (4-24hrs) (24-48hrs) |
| 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) |
| 19376789 | Result | 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. |
| 26735154 | Result | 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. |
| 22763903 | Result | 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. |
| 28154824 | Result | 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. |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |