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

Primary Purpose

Colon Neoplasm, Surgery, Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Left hemicolectomy, laparoscopic technique
Sponsored by
Ostfold Hospital Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Neoplasm

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ostfold Hospital Trust, MossRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

Active Comparator

Arm Label

Left hemicolectomy without nerve blocks

Left hemicolectomy with TAP block

Left hemicolectomy with QL block

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Use of analgesics - "change" is being assessed
Amount of analgesics used postoperative

Secondary Outcome Measures

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
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
Nonsteroidal anti-inflammatory drug consumption - "change" is being assessed
Amount of different medicaments in mg
Postoperative nausea and vomiting - "change" is being assessed
0 - 3 score where None = 0, Little nausea = 1, Can not eat = 2, Vomiting = 3
Antiemetic administered - "change" is being assessed
Amount of different medicaments in mg
Sedation scores - "change" is being assessed
Sleepy or active. Score: Awake = 0, Tired = 1, Falls asleep = 2, Asleep all the time = 3

Full Information

First Posted
February 28, 2018
Last Updated
March 12, 2019
Sponsor
Ostfold Hospital Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03458689
Brief Title
Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Patients Undergoing Left Hemicolectomy
Official Title
Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Patients Undergoing Left Hemicolectomy: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 28, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ostfold Hospital Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Neoplasm, Surgery, Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
Information connecting the patients to the data are kept locked and will be destroyed after the end of the investigation
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Left hemicolectomy without nerve blocks
Arm Type
Other
Arm Description
Left hemicolectomy, laparoscopic technique Enteral and parenteral analgesics such as paracetamol and oksykodon
Arm Title
Left hemicolectomy with TAP block
Arm Type
Active Comparator
Arm Description
Left hemicolectomy, laparoscopic technique TAP block bilateral with Naropin 3,75 mg/ml, 2 x 20 ml
Arm Title
Left hemicolectomy with QL block
Arm Type
Active Comparator
Arm Description
Left hemicolectomy, laparoscopic technique QL block bilateral with Naropin 3,75 mg/ml, 2 x 20 ml
Intervention Type
Procedure
Intervention Name(s)
Left hemicolectomy, laparoscopic technique
Other Intervention Name(s)
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
Intervention Description
Left hemicolectomy, Laparoscopic technique
Primary Outcome Measure Information:
Title
Use of analgesics - "change" is being assessed
Description
Amount of analgesics used postoperative
Time Frame
1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Secondary Outcome Measure Information:
Title
Pain at the incision site - "change" is being assessed
Description
VPS (Verbal Pain Score): No pain = 0, Slight pain = 1, Moderate pain= 2, Severe pain = 3
Time Frame
1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Title
Deep pain and pain on coughing - "change" is being assessed
Description
VPS (Verbal Pain Score): No pain = 0, Slight pain = 1, Moderate pain= 2, Severe pain = 3
Time Frame
1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Title
Nonsteroidal anti-inflammatory drug consumption - "change" is being assessed
Description
Amount of different medicaments in mg
Time Frame
1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Title
Postoperative nausea and vomiting - "change" is being assessed
Description
0 - 3 score where None = 0, Little nausea = 1, Can not eat = 2, Vomiting = 3
Time Frame
1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Title
Antiemetic administered - "change" is being assessed
Description
Amount of different medicaments in mg
Time Frame
1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Title
Sedation scores - "change" is being assessed
Description
Sleepy or active. Score: Awake = 0, Tired = 1, Falls asleep = 2, Asleep all the time = 3
Time Frame
1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Sverre Vamnes, MD, Ph.D.
Phone
0047 91305016
Email
janvam@so-hf.no
First Name & Middle Initial & Last Name or Official Title & Degree
Klaus Risnes, MD
Phone
0047 99329515
Email
klaris@so-hf.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Sverre Vamnes, MD, Ph.D.
Organizational Affiliation
Senior Consultant
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ostfold Hospital Trust, Moss
City
Grålum
State/Province
Ostfold
ZIP/Postal Code
1714
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Sverre Vamnes, MD, Ph.D.
Phone
+47 91608896
Email
janvam@so-hf.no
First Name & Middle Initial & Last Name & Degree
Knut Inge Solbakk, md
Phone
+47 90933106
Email
knisol@so-hf.no

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27429253
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.
Results Reference
result
PubMed Identifier
27755488
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. Erratum In: Reg Anesth Pain Med. 2018;43:111.
Results Reference
result
PubMed Identifier
19376789
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. Erratum In: Br J Anaesth. 2009 Oct;103(4):622.
Results Reference
result
PubMed Identifier
26735154
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.
Results Reference
result
PubMed Identifier
28667547
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. Surg Endosc. 2018 Jan;32(1):376-382. doi: 10.1007/s00464-017-5686-7. Epub 2017 Jul 1.
Results Reference
result
PubMed Identifier
28154824
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.
Results Reference
result

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

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