Postoperative Pain, Acute
Conditions
Keywords
cholecystectomy, thoracoabdominal nerves block, transversus abdominis plane block, interfascial plane block, regional analgesia
Brief summary
This randomized controlled study is designed to evaluate the postoperative analgesic effect of the ultrasound-guided modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy. The investigators hypothesized that the US-guided M-TAPA would be more effective in postoperative pain control than the US-guided subcostal transversus abdominis plane block (TAPB).
Detailed description
Patients (Age\>18 years) undergoing elective laparoscopic cholecystectomy are randomly allocated to receive bilateral US-guided M-TAPA (n=30) or bilateral subcostal TAPB (n=30) using 0.375% ropivacaine 15ml (total 30ml) before surgical incision. The blinded investigator evaluates each patient's parameters (Numeric rating scale, nausea, vomiting, pruritis, and patient satisfaction) at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge. The primary outcome is pain severity evaluated by a NRS at 12hours postoperatively.
Interventions
PROCEDUREType of interfascial plane block
In the M-TAPA group, after finding the right 10th costal cartilage using ultrasound guidance, a anesthesiologist inject 0.375% ropivacaine 15ml into the lower aspect of the chondrium. Perform left M-TAPA in the same way. In the subcostal TAPB group, a anesthesiologist inject 0.375% ropivacaine 15ml into end of right rectus abdominis muscle using ultrasound guidance. Perform left subcostal TAPB in the same way.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants were blinded to the allocation, because that investigator performed nerve block after induction of anesthesia. The outcome assessor not involved in this study will investigate the outcomes
Intervention model description
A prospective randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled to undergo elective laparoscopic cholecystectomy * American Society of Anesthesiologists (ASA) physical classification I-II
Exclusion criteria
* American Society of Anesthesiologists (ASA) physical classification III or more * Chronic pain, chronic analgesic or antidepressant or anticonvulsant use * Allergies to anesthetic or analgesic medications used in the protocol * Single port laparoscopic cholecystectomy * Patients with infection at the abdominal wall * Medical or psychological disease that can affect the treatment response * Do not understand our study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum postoperative pain score during 12hours postoperatively | at 12hour postoperatively. | maximum pain score measured by the 11-pointed numeric rating scale (0: none/10: worst pain) during 12hours postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain score at rest | at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge | Change in the pain severity measured by the 11-pointed numeric rating scale (0: none/10: worst pain) pain score at resting |
| Postoperative pain score during coughing | at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge | Change in the pain severity measured by the 11-pointed numeric rating scale (0: none/10: worst pain) pain score during coughing |
| Patient satisfaction before discharge | at immediately before discharge | Patient satisfaction measured by the 7-pointed Likert scale. (1: Strongly dissatisfaction/ 7: Strongly satisfaction) |
| Occurrence rate of postoperative nausea, vomiting | at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge. | Incidence of postoperative nausea and vomiting (%) |
Countries
South Korea
Outcome results
None listed