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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Sham | Sham Comparator | After the induction of general anaesthesia, the rectus sheath block and ilioinguinal nerve block will be performed to patients with a solution containing only physiological saline. |
|
| Group Block | Active Comparator | After the induction of general anaesthesia, the rectus sheath block and ilioinguinal nerve block will be performed to patients with a solution containing 0.25% bupivacaine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rectus sheath and ilioinguinal nerve block with physiological saline | Procedure | Rectus sheath and ilioinguinal nerve block without local anaesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome | Determination of the total amount of narcotic painkillers used during this period. | 24 hours post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome | 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. | 24 hours post-surgery |
| Secondary Outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yasemin Sincer, MD | Koç University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Koç University Hospital | Istanbul | Zeytinburnu | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38305014 | Result | Ozkalayci O, Karakaya MA, Yenigun Y, Cetin S, Darcin K, Akyollu B, Arpali E, Kocak B, Gurkan Y. Effects of erector spinae plane block on opioid consumption in patients undergoing hand-assisted laparoscopic donor nephrectomy: a randomized controlled trial. Minerva Anestesiol. 2024 Mar;90(3):154-161. doi: 10.23736/S0375-9393.23.17706-6. Epub 2024 Feb 2. | |
| 36326419 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 1, 2025 | Apr 19, 2025 |
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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.
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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.
| Rectus sheath and ilioinguinal nerve block with local anaesthesia | Procedure | Rectus sheath and ilioinguinal nerve block with local anaesthesia |
|
|
Incidence of narcotic-related side effects
| 24 hours post-surgery |
| Secondary Outcome | Length of hospital stay | through patient discharge postoperative, an average of 5 days postoperatively |
| Secondary Outcome | Determination of the total amount of narcotic painkillers used. | 1,3,6,12 hours post-surgery |
| Secondary Outcome | 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. | 1,3,6,12 hours post-surgery |
| Gunaydin B, Ucar T, Arpali E, Akyollu B, Akinci S, Karatas C, Oztorun K, Kocak B. Hand-assisted laparoscopic donor nephrectomy: 1864 cases in 15 years of experience. Turk J Med Sci. 2022 Aug;52(4):1322-1328. doi: 10.55730/1300-0144.5438. Epub 2022 Aug 10. |
| ICF_000.pdf |
| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
| D000772 | Anesthesia, Local |
| D003766 | Dental Occlusion |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D003813 | Dentistry |
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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