Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Patients Undergoing Left Hemicolectomy

Surgery Clinical Trial

Official title:

Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Patients Undergoing Left Hemicolectomy: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03458689
• Other study ID #: 1813
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2019
• Source: Ostfold Hospital Trust
• Contact: Jan Sverre Vamnes, MD, Ph.D.
• Phone: 0047 91305016
• Email: janvam[@]so-hf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The enhanced recovery after surgery and laparoscopic approach have been proven beneficial in surgery of the colon. However, patients have still pain, nausea and vomiting postoperatively. Postoperative pain is an expected but undesirable effect after an operation. This study will compare Transabdominis Plane (TAP) Block and Quadratus Lumborum (QL) Block with the common postoperative treatment with enteral and parenteral analgesics.

Description:

TAP is a recommended multimodal method of reducing postoperative pain in laparoscopic and open surgery. TAP block seems to be feasible and effective in postoperative pain control without increasing morbidity in colon resections. QL block 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 QL block reach higher than the TAP block, and might explain the better effect of the QL block than TAP blocks on postoperative pain after caesarean delivery. For this study the investigators standardize the type of surgery to be left hemicolectomy. This is the most common procedure on colon.

Power and Sample Size Calculator:

The number of patients required for the study was calculated on the basis of opioid consumption. We were interested in a reduction by 20% in the group given QLB. Assuming α=0,05, we calculated that we need 69 patients (23 in each group) to achieve a power of 80% (β=0.2).

75 adult patients scheduled for left hemicolectomy have to be included.

Subcutaneous wound infiltration at the end of surgery in all patients with ropivacaine 2 mg/ml, 20 ml. Maximum allowed dosis of Ropivacain is 3 mg/kg bodyweight (BW), dosis reduction if BW<70 kg Premedication: Paracetamol 2 g and Diklofenak 100 mg orally. General anaesthesia: TCI: Propofol and Remifentanil Ondansetron 4 mg, dexamethasone 8 mg and Oxycodone 5 mg intravenously at the end of surgery.

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 2 - 5 mg IV.

When nausea and vomiting occure 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 evaluated by a 4-points verbal pain score (VPS; with no pain=0, slight pain = 1, Moderate pain = 2, and severe pain = 3) on admission to recovery, and every hour until discharge.

Rescue analgesic consumption during 0 to 4, 4 to 24 and 24 to 48 h. Sedation, 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 or ward 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), antiemetics administered (0 to 24 and 24 to 48 H), grade of sedation (0 to 10 scale, where 0 = awake, and 10 = aroused on stimulation), and other side effects and symptoms of LA toxicity.

Telephone interview at 24 h, 48 h and 7 days, with questions:

Pain during rest and activity using the VPS Total need of analgesics Sedation Nausea Level of activity Overall satisfaction with the per- and postoperative period on a 0 - 3 scale: not satisfied, slight, moderate or highly satisfied.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• 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 LA

• 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

• Colon Neoplasm
• Colonic Neoplasms
• Pain, Postoperative
• Surgery

Intervention

Procedure:
• Left hemicolectomy, laparoscopic technique
Left hemicolectomy, 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

Pirrera B, Alagna V, Lucchi A, Berti P, Gabbianelli C, Martorelli G, Mozzoni L, Ruggeri F, Ingardia A, Nardi G, Garulli G. Transversus abdominis plane (TAP) block versus thoracic epidural analgesia (TEA) in laparoscopic colon surgery in the ERAS program. — 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 (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Secondary	Pain at the incision site - "change" is being assessed	VPS (Verbal Pain Score): No pain = 0, Slight pain = 1, Moderate pain= 2, Severe pain = 3	1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Secondary	Deep pain and pain on coughing - "change" is being assessed	VPS (Verbal Pain Score): No pain = 0, Slight pain = 1, Moderate pain= 2, Severe pain = 3	1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Secondary	Nonsteroidal anti-inflammatory drug consumption - "change" is being assessed	Amount of different medicaments in mg	1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Secondary	Postoperative nausea and vomiting - "change" is being assessed	0 - 3 score where None = 0, Little nausea = 1, Can not eat = 2, Vomiting = 3	1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Secondary	Antiemetic administered - "change" is being assessed	Amount of different medicaments in mg	1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Secondary	Sedation scores - "change" is being assessed	Sleepy or active. Score: Awake = 0, Tired = 1, Falls asleep = 2, Asleep all the time = 3	1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)