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

NCT ID: NCT03458689

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-28
• Study Completion Date: 2020-12-31

Brief 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.

Detailed 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.

Conditions

Colon Neoplasm; Surgery; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Left hemicolectomy without nerve blocks

Left hemicolectomy, laparoscopic technique Enteral and parenteral analgesics such as paracetamol and oksykodon

Group Type: OTHER

Left hemicolectomy, laparoscopic technique

Intervention Type: PROCEDURE

Left hemicolectomy, Laparoscopic technique

Left hemicolectomy with TAP block

Left hemicolectomy, laparoscopic technique TAP block bilateral with Naropin 3,75 mg/ml, 2 x 20 ml

Group Type: ACTIVE_COMPARATOR

Left hemicolectomy, laparoscopic technique

Intervention Type: PROCEDURE

Left hemicolectomy, Laparoscopic technique

Left hemicolectomy with QL block

Left hemicolectomy, laparoscopic technique QL block bilateral with Naropin 3,75 mg/ml, 2 x 20 ml

Group Type: ACTIVE_COMPARATOR

Left hemicolectomy, laparoscopic technique

Intervention Type: PROCEDURE

Left hemicolectomy, Laparoscopic technique

Interventions

Left hemicolectomy, laparoscopic technique

Left hemicolectomy, Laparoscopic technique

Intervention Type: PROCEDURE

Other Intervention Names

QL block bilateral with ropivacain 3,75 mg/ml (2 x 20 ml); TAP block with ropivacain 3,75 mg/ml (2 x 20 ml); Traditional analgesics such as paracetamol and oksycodon

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ostfold Hospital Trust

OTHER

Sponsor Role: lead

Responsible Party

Jan Sverre Vamnes

Senior conultant, Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan Sverre Vamnes, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Senior Consultant

Locations

Ostfold Hospital Trust, Moss

Grålum, Østfold fylke, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Jan Sverre Vamnes, MD, Ph.D.

Role: CONTACT

janvam@so-hf.no

0047 91305016

Klaus Risnes, MD

Role: CONTACT

klaris@so-hf.no

0047 99329515

Facility Contacts

Jan Sverre Vamnes, MD, Ph.D.

Role: primary

janvam@so-hf.no

+47 91608896

Knut Inge Solbakk, md

Role: backup

knisol@so-hf.no

+47 90933106

References

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.

Reference Type: RESULT

PMID: 27429253 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27755488 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19376789 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26735154 (View on PubMed)

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. Surg Endosc. 2018 Jan;32(1):376-382. doi: 10.1007/s00464-017-5686-7. Epub 2017 Jul 1.

Reference Type: RESULT

PMID: 28667547 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28154824 (View on PubMed)

Other Identifiers

1813

Identifier Type: -

Identifier Source: org_study_id