Obesity, Morbid, Postoperative Nausea and Vomiting, Postoperative Pain
Conditions
Keywords
Sleeve gastrectomy, Transversus abdominis plane block, Postoperative pain management
Brief summary
Sleeve gastrectomy is the most performed bariatric procedure worldwide. Postoperative pain management is a challenging issue. In this trial, the investigators aimed to explore the effects of laparoscopic guided transversus abdominis plane (TAP) block on postoperative pain management in patient those were performed laparoscopic sleeve gastrectomy.
Detailed description
TAP block is a regional anesthesia technique which could be performed easily especially by laparoscopy and are used in various surgical procedures. In that technique, blockade of the plane between internal oblique muscle and transversus abdominis muscle is performed by infiltration of local anesthesics drugs. Therefore , reduction of postoperative pain could be lead to decrease in postoperative complications.
Interventions
PROCEDURETransversus abdominis plane block
TAP block will be performed by a needle which is punctured at the midaxillary line between subcostal margin and iliac crest, once tip of the needle had detected just above the peritoneum the syringe pulled back.
DRUGPlacebo
20 ml saline solution will be injected by a needle which is punctured at the midaxillary line between subcostal margin and iliac crest, once tip of the needle had detected just above the peritoneum the syringe pulled back.
Sponsors
Samsun Education and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Forty patients had divided into two groups; TAP block group (TAP-B) and placebo (P) group. Every group contained 20 patients and randomization was performed by sealed envelope method. Patient and the data collector resident didn't know the which procedure was done thus single-blinded randomization were provided.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* patients between 18-65 * undergo Laparoscopic sleeve gastrectomy
Exclusion criteria
* Bupivacaine allergy * having chronic pain or taking pain management * ASA ( The American Society of Anesthesiologists Physical Classification System) Class 4 or * Patients who were performed additional procedures including cholecystectomy, hiatal hernia repair or abdominal hernia repair
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| visual analogue scale (VAS) scores | 24th ours | VAS scores of the patients within 24 hours postoperatively minimun:0 maximum:10 |
| postoperative analgesia doses | within 24 hours postoperatively | totally consumed analgesics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nausea and vomiting score | within 24 hours postoperatively | PONV (Postoperative nausea and vomiting) score calculated with PONV scale: score 0: no nausea or vomiting, score 1:mild nausea, not requesting medication, score 2: moderate nausea requesting medication, score 3: severe nausea and/or vomiting minimum:0 maximum:3 |
| first mobilization and flatus time | within 24 hours postoperatively | first mobilization and flatus time |
| time of first opioid administration | within 24 hours postoperatively | time of first opioid administration |
Other
| Measure | Time frame | Description |
|---|---|---|
| operation time | time from first incision to last suture | operation time |
Countries
Turkey (Türkiye)
Outcome results
None listed