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

Sponsor
Ostfold Hospital Trust (Other)
Overall Status
Unknown status
CT.gov ID
NCT03458689
Collaborator
(none)
75
Enrollment
1
Location
3
Arms
34.1
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Left hemicolectomy, laparoscopic technique
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Masking Description:
Information connecting the patients to the data are kept locked and will be destroyed after the end of the investigation
Primary Purpose:
Treatment
Official Title:
Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Patients Undergoing Left Hemicolectomy: A Randomized Controlled Trial
Actual Study Start Date :
Feb 28, 2018
Anticipated Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Other: Left hemicolectomy without nerve blocks

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

Procedure: Left hemicolectomy, laparoscopic technique
Left hemicolectomy, Laparoscopic technique
Other 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

    		•
    Active Comparator: Left hemicolectomy with TAP block

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

    Procedure: Left hemicolectomy, laparoscopic technique
    Left hemicolectomy, Laparoscopic technique
    Other 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

    		•
    Active Comparator: Left hemicolectomy with QL block

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

    Procedure: Left hemicolectomy, laparoscopic technique
    Left hemicolectomy, Laparoscopic technique
    Other 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Use of analgesics - "change" is being assessed [1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)]

      Amount of analgesics used postoperative

    Secondary Outcome Measures

    1. Pain at the incision site - "change" is being assessed [1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)]

      VPS (Verbal Pain Score): No pain = 0, Slight pain = 1, Moderate pain= 2, Severe pain = 3

    2. Deep pain and pain on coughing - "change" is being assessed [1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)]

      VPS (Verbal Pain Score): No pain = 0, Slight pain = 1, Moderate pain= 2, Severe pain = 3

    3. Nonsteroidal anti-inflammatory drug consumption - "change" is being assessed [1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)]

      Amount of different medicaments in mg

    4. Postoperative nausea and vomiting - "change" is being assessed [1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)]

      0 - 3 score where None = 0, Little nausea = 1, Can not eat = 2, Vomiting = 3

    5. Antiemetic administered - "change" is being assessed [1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)]

      Amount of different medicaments in mg

    6. Sedation scores - "change" is being assessed [1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)]

      Sleepy or active. Score: Awake = 0, Tired = 1, Falls asleep = 2, Asleep all the time = 3

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ostfold Hospital Trust, Moss Grålum Ostfold Norway 1714

    Sponsors and Collaborators

    • Ostfold Hospital Trust

    Investigators

    • Principal Investigator: Jan Sverre Vamnes, MD, Ph.D., Senior Consultant

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jan Sverre Vamnes, Senior conultant, Ph.D., Ostfold Hospital Trust
    ClinicalTrials.gov Identifier:
    NCT03458689
    Other Study ID Numbers:
    • 1813
    First Posted:
    Mar 8, 2018
    Last Update Posted:
    Mar 13, 2019
    Last Verified:
    Mar 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Colonic Neoplasms
    Pain, Postoperative
    Analgesics

    Study Results

    No Results Posted as of Mar 13, 2019