Regional Anesthesia Morbidity
Conditions
Keywords
rectus sheath block, ilioinguinal nerve block, hand assisted donor nephrectomy
Brief summary
The goal of this double-blind randomized control clinical trial is to investigate the effectiveness of regional anaesthesia blocks (rectus sheath block and ilioinguinal nerve block) on pain management in patients undergoing hand assisted laparoscopic donor nephrectomy surgery. The main question it aims to answer is: Does combined rectus sheath block and ilioinguinal nerve block lower the amount of postoperative opioid consumption? Does reduced postoperative opioid consumption reduce the incidence of potential opioid related side effects? Does the application of nerve block affect length of hospital stay? Researchers will compare patients who had nerve blocks with regional anaesthesia to a placebo group to see if total postoperative opioid consumption. Participants will be randomly divided in two. Regional anaesthesia with local anaesthesia or a placebo will be performed. Patients will be followed 24 hours postoperatively to measure total opioid consumption. Possible side effects, complications and length of hospital stay will be noted.
Detailed description
In this study, it was planned to provide pain management after HALDN by applying a combined rectus sheath block and ilioinguinal nerve block. It is aimed to demonstrate the postoperative analgesic effectiveness of combined rectus sheath and ilioinguinal nerve block applied in addition to general anaesthesia in HALDN surgery. It was aimed to examine the amount of narcotic analgesic consumption in patients who received local anaesthetic for the first 24 hours after surgery. Regional anaesthesia applications with physiological saline, defined as 'Sham Block' in the literature, were preferred as the comparison group. This method is a widely used comparison method and is used to obtain a double-blind study design.
Interventions
PROCEDURERectus sheath and ilioinguinal nerve block with physiological saline
Rectus sheath and ilioinguinal nerve block without local anaesthesia
PROCEDURERectus sheath and ilioinguinal nerve block with local anaesthesia
Rectus sheath and ilioinguinal nerve block with local anaesthesia
Sponsors
Koç University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
The patient will be blind whether they receive local anaesthesia or physiological saline as the nerve block ingredient. The care providers will be blind to the solution when they are performing the regional anaesthesia. The care providers will be blind when they are monitoring the patient after surgery.
Intervention model description
Group A: After patients anesthetized under general anaesthesia, a combined rectus sheath block and ilioinguinal nerve block will be applied with physiological saline. Group B: After patients anesthetized under general anaesthesia, a combined rectus sheath block and ilioinguinal nerve block will be applied with 0.25% bupivacaine.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* The donors reviewed by the transplant committee and deemed suitable for nephrectomy. * Laparoscopic hand assisted donor nephrectomy operation is planned.
Exclusion criteria
* Allergy to any of the drugs to be used in treatment * Patients using chronic narcotics or narcotic receptor agonists * Patients with psychiatric disorders * Patients with chronic organ failure * Patients without end organ damage * The patients who did not give consent * Foreign national patients * Patients with American Society of Anaesthesiologists (ASA) physical status classification score III and above
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome | 24 hours post-surgery | Determination of the total amount of narcotic painkillers used during this period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome | 24 hours post-surgery | Numeric rating scale scores for pain after surgery. Numeric rating scale scores for pain of 1 being minimum amount of pain and 10 being the worse pain. |
Countries
Turkey (Türkiye)
Outcome results
None listed