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Laparoscopic cholecystectomy although a minimally invasive procedure, may be accompanied by considerable pain after surgery. More recently transversus abdominis plane (TAP) block was extensively studied as a potential analgesic maneuver after laparoscopic cholecystectomy. The subcostal approach (OSTAP block) is a variation on the TAP block that produces reliable supraumbilical analgesia.
Laparoscopic cholecystectomy is a minimally invasive widespread surgical procedure, with postoperative lower pain scores and quick recovery of the patient. However some of patients may complain of considerable pain after surgery . There are several approaches to postoperative pain management after laparoscopic cholecystectomy such as patient-controlled analgesia with opioids (IV-PCA), neuraxial blocks, intraperitoneal injection of local anesthetics, wound infiltration, each being more or less effective, with specific side effects.
The transversus abdominis plane block (TAP-Block) is a regional analgesia technique that comes as an alternative to "classical" procedures of postoperative analgesia. Described by Rafi and McDonnell et al. this technique has undergone some changes over times, which increased its efficiency. Thus, Hebbard et al. described ultrasound subcostal oblique approach (OSTAP) of the block allowing analgesia in both the upper and lower abdomen, with a lower rate of complications due to the direct ultrasound visualization. Different studies confirmed the analgesic efficacy of this technique and the postoperative opioid sparing effect after laparoscopic cholecystectomy .
Traditionally, the transversus abdominis plane block is achieved with classical amino-amides local anesthetics, bupivacaine, levobupivacaine and ropivacaine being the most commonly used .
Based on the local anesthetic properties of pethidine, a synthetic opioid, our study aimed to evaluate prospectively the analgesic efficacy of pethidine in achieving transversus abdominis plane block by ultrasound oblique subcostal approach in patients scheduled for elective laparoscopic cholecystectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Oblique subcostal tap block with normal sterile saline ,20 ml, bilateral, single shot,24h |
|
| Bupivacaine | Active Comparator | Oblique subcostal tap block with bupivacaine 0,25% ,20 ml, bilateral, single shot,24h |
|
| Pethidine | Active Comparator | Oblique subcostal tap block with pethidine 1% ,10 ml,bilateral,single shot,24h |
|
| Pethidine Local Infiltration (L.I.) | Active Comparator | Local infiltration of pethidine 1% at trocar insertion sites, 5ml /site, 24h compared with Tap Block with pethidine 1% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Tap Block performed with normal sterile saline 20 ml on the right side and 20 ml on the left side |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores | This outcome is measured with a visual analogue scale (VAS, from 0 to 10) at 2 hours postoperative, while the patient is in his bed. This outcome is recorded in and compared between all four groups. | Recorded 2 hours postoperative |
| Pain Scores | This outcome is measured with a visual analogue scale (VAS, from 0 to 10) at 6 hours postoperative, while the patient is in his bed. This outcome is recorded in and compared between all four groups. | Recorded 6 hours postoperative |
| Pain Scores | This outcome is measured with a visual analogue scale (VAS, from 0 to 10) at 12 hours postoperative, while the patient is in his bed. This outcome is recorded in and compared between all four groups. | Recorded 12 hours postoperative |
| Pain Scores | This outcome is measured with a visual analogue scale (VAS, from 0 to 10) at 24 hours postoperative, while the patient is in his bed. This outcome is recorded in and compared between all four groups. | Recorded 24 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative fentanyl consumption | Recording total amount of intraoperative fentanyl consumption | 0-4 hours |
| Time to first opioid administration in Post Anesthetic Care Unit | Recording time to first opioid administration in post aesthetic care unit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caius M Breazu, MD | Contact | +40743010012 | csbreazu@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Daniela Ionescu, MD | University of Medicine and Pharmacy "Iuliu Hatieganu" Cluj-Napoca,Romania | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Institute of Gastroenterology and Hepatology "Prof.dr.Octavian Fodor" | Recruiting | Cluj-Napoca | Cluj | 400162 | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36318686 | Derived | Breazu C, Margarit S, Bartos A, Ionescu D. Postoperative Analgesia after Laparoscopic Cholecystectomy - Prospective, Randomized, Double Blind, Control Trial. Chirurgia (Bucur). 2022 Oct;117(5):563-571. doi: 10.21614/chirurgia.2769. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D008614 | Meperidine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Bupivacaine | Drug | Tap Block performed with Bupivacaine 0,25% 20 ml on the right side and 20 ml on the left side. |
|
|
| Pethidine | Drug | Tap Block performed with pethidine 1% 10 ml on the right side and 10 ml on the left side |
|
|
| Pethidine Local Infiltration (L.I) | Drug | Local infiltration of port sites (trocar insertion sites) with pethidine 1% 5ml each port (trocar site) ,4 ports total 20 ml pethidine 1% |
|
|
| 0-4 hours postoperative |
| Cumulative opioid consumption | Recording total amount of opioids used in postoperative period | Recorded in the first 24 hours perioperative period |
| Side effects | nausea, vomiting, pruritus and sedation on a 4 point scale as none, mild, moderate and severe | Recorded in the first 24 hours postoperative |
| D000588 |
| Amines |
| D007540 | Isonipecotic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |