Comparison of Paravertebral Block and Subcostal Transversus Abdominis Plane Block in Laparoscopic Nephrectomy

Sponsor
Istanbul University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05723341
Collaborator
(none)
90
1
3
9.5
9.5

Study Details

Study Description

Brief Summary

Most of the patients undergoing laparoscopic partial/radical nephrectomy can experience moderate or severe postoperative pain, and inadequate control of this pain can cause negative consequences such as development of chronic pain, pulmonary and cardiac events, and side effects of long term opioid usage. Due to these adverse outcomes, ultrasonography-guided plane blocks can be beneficial for these patients to decrease opioid consumption. In this study, we aim to compare ultrasonography-guided plane blocks: Paravertebral block and subcostal transversus abdominis plane block and traditional method: patient controlled analgesia with opioids. We hypothesized that analgesic efficacy in both paravertebral and subcostal TAP blocks will have similar outcomes but better than traditional method.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

More than half of patients undergoing laparoscopic partial/radical nephrectomy develop moderate or severe postoperative pain. Inadequate control of postoperative pain may delay early mobilization and rehabilitation, increase pulmonary and thromboembolic events, prolong hospital stay, and decrease patient satisfaction. Inadequate postoperative pain control may lead to the development of chronic pain, resulting in long-term opioid use. In the traditional analgesia model provided with opioids, patients may develop side effects such as nausea, vomiting, hypotension, loss of consciousness, and respiratory depression. For this reason, it would be more rational to provide analgesia with regional methods, which are decided according to the suitability of the patient and the surgical procedure, rather than the use of intravenous drugs. Ultrasonography-guided plane blocks, one of the main elements of multimodal analgesia, are used more frequently with the introduction of ultrasonography into daily practice. These blocks are frequently preferred in daily practice as they reduce opioid consumption by providing effective postoperative analgesia with low complication rates and ease of application.

In the ultrasonography-guided paravertebral block, local anesthetic is injected into the triangle constituted by superior costotransvers ligament, parietal pleura and vertebral body where the spinal nerves emerge from the intervertebral foramen. Ipsilateral somatic and sympathetic nerve blockade is observed. It is a body block that can be used to provide both analgesia and anesthesia. Paravertebral block provides successful postoperative analgesia, reduces the decline in postoperative respiratory function, accelerates the recovery of respiratory mechanics, and reduces postoperative vomiting, allowing earlier initiation of oral intake.

Ultrasonography-guided subcostal transversus abdominis plane block is a relatively safe and simple body block in which local anesthetic is injected into the fascial plane located between posterior rectus sheath and transversus abdominis muscle. The transversus abdominis plane is the fascial plane superficial to the transversus abdominis muscle, the innermost muscular layer of the anterolateral abdominal wall. The subcostal transversus abdominis plane block ideally anesthetizes the intercostal nerves T6-T9 between the rectus abdominis sheath and the transversus abdominis muscle. It is a truncal block that has drawn attention recently, both because it is easier to apply and because it is a more peripheral block.

In this study we aim to compare the effects of two truncal blocks on postoperative pain, morphine consumption, chronic pain and complications.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
RANDOMISED SINGLE BLINDED INTERVENTIONALRANDOMISED SINGLE BLINDED INTERVENTIONAL
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Postoperative Analgesic Effects of Ultrasonography-Guided Paravertebral Block and Subcostal Transversus Abdominis Plane Block in Patients Undergoing Laparoscopic Nephrectomy
Anticipated Study Start Date :
Feb 15, 2023
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Paravertebral Block Group

In this group, preoperative ultrasound-guided paravertebral block will be performed ipsilateraly via peripheral block needle with 20 ml bupivacaine %0,25 in the paravertebral space.

Drug: Bupivacain
%0,25
Other Names:
  • Marcaine
  • Drug: Morphine
    In this group, patients will be postoperatively administered patient-controlled analgesia with morphine only.
    Other Names:
  • Morphine Sulfate
  • Active Comparator: Subcostal Transversus Abdominis Plane Block Group

    In this group, preoperative ultrasound-guided subcostal transversus abdominis plane block will be performed ipsilateraly via peripheral block needle with 20 ml bupivacaine %0,25 into the fascial plane between erector spine muscle and transverse process

    Drug: Bupivacain
    %0,25
    Other Names:
  • Marcaine
  • Drug: Morphine
    In this group, patients will be postoperatively administered patient-controlled analgesia with morphine only.
    Other Names:
  • Morphine Sulfate
  • Active Comparator: Intravenous Patient Controlled Analgesia

    In this group, postoperative patient controlled analgesia with morphine will be preferred for postoperative analgesia method.

    Drug: Morphine
    In this group, patients will be postoperatively administered patient-controlled analgesia with morphine only.
    Other Names:
  • Morphine Sulfate
  • Outcome Measures

    Primary Outcome Measures

    1. Postoperative Intravenous Total Morphine Consumption [Up to 24 hours]

      The total dosage of intravenous morphine consumption in 24 hours.

    Secondary Outcome Measures

    1. Postoperative Visual Analog Score (VAS) [Up to 24 hours]

      A visual analog score (VAS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable

    2. Rescue analgesia administration amounts [Up to 24 hours]

      Time of postoperative rescue analgesic requirement time.

    3. Incidence of complications due to the regional blocks [Up to first week]

      Incidence of hematoma, pneumothorax (pleural puncture), local anesthetic toxicity, infection vs.

    4. Chronic postoperative pain [Up to 90th day]

      Patients' chronic pain will be assessed by the examiner questioning each patient about the pain status on postoperative 90th day.

    5. Lenght of Hospital Stay [Up to first week]

      Lenght of Hospital Stay

    Other Outcome Measures

    1. Indidence of PONV (postoperative nausea and vomiting) [Up to 24 hours]

      Incidence of postoperative nausea and vomiting

    2. Respiratuar Depression [Up to 24 hours]

      Incidence of respiratory depression due to iv orphine in the postoperative follow-up.

    3. Postoperative Ramsay Sedation Scale (RSS) [Up to 24 hours]

      Ramsay sedation scale requires the patient to rate their sedation on a defined scale. For example, 1: anxious and agitated or restless, or both 2: cooperative, oriented and tranquil 3: responds to commands only 4: brisk response to stimulus 5: sluggish response to stimulus 6: no response to stimulus.

    4. Itching [Up to 24 hours]

      Incidence of itching due to iv morphine in the postoperative follow-up.

    5. Surgeon Satisfaction [Up to 24 hours]

      Satisfaction score, 0: very unsatisfied 3: very unsatisfied.

    6. Patient Satisfaction [Up to 24 hours]

      Satisfaction score, 0: very unsatisfied 3: very unsatisfied.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age of 18-75

    • Patients who are ASA (American Society of Anesthesiology): I-II

    • Patients who will have laparoscopic partial/radical nephrectomy

    • Patients who volunteer to participate in the study

    Exclusion Criteria:
    • Patients with any kind of coagulopathy

    • Patients with severe cardiac, pulmonary, renal or liver disease

    • Patients who have difficulty comprehending the IV PCA device

    • Patients with local anesthetic allergy

    • Patients with chronic opioid use

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istanbul University Istanbul Turkey

    Sponsors and Collaborators

    • Istanbul University

    Investigators

    • Principal Investigator: Meltem Savran Karadeniz, MD, Istanbul Faculty of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Meltem Savran Karadeniz, Associate professor, Istanbul University
    ClinicalTrials.gov Identifier:
    NCT05723341
    Other Study ID Numbers:
    • 2022-1276671
    First Posted:
    Feb 10, 2023
    Last Update Posted:
    Feb 10, 2023
    Last Verified:
    Feb 1, 2023
    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
    Keywords provided by Meltem Savran Karadeniz, Associate professor, Istanbul University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 10, 2023