Single Port Laparoscopic Adnexal Surgery
Conditions
Brief summary
In this study, the investigators aimed to demonstrate if the quality of recovery in patients undergoing single-port laparoscopic adnexal surgery, with preoperative rectus sheath block and intraoperative opioid administration based on analgesia nociception index, improves compared to the patients without block.
Interventions
DRUGUltrasound guided rectus sheath block with dexmedetomidine
Intervention Group: Ultrasound guided rectus sheath block with 0.5% ropivacaine 20ml at each side (bilateral)
DRUGUltrasound guided rectus sheath block with normal saline
Control Group: Ultrasound guided rectus sheath block with 0.9% normal saline 20ml at each side (bilateral)
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Investigator prepared the drug and participant and outcomes assessor were blind to the group allocation
Intervention model description
Double blind randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. Adult female patient aged 19 years or older undergoing elective single-port laparoscopic adnexal surgery under general anesthesia at Yonsei Cancer Center 1\. patients with moderate to severe pain before surgery 2. patients with history of taking chronic analgesic use, 3. patients allergic or hypersensite to remifentanil or local anesthetic (ropivacaine), 4. patients with infection at the site of the block, 5. patietns who cannot communicate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery 40 scale score at postoperative 24 hour | 24 hours after the end of surgery | Postoperative quality of recovery according to the block performance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rescue analgesics administered up to 24 hours postoperatively | intraoprative and postoperative 24hours | To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction |
| satisfaction with pain control | intraoprative and postoperative 24hours | Patient self-rated overall satisfaction with pain control. Evaluated on an 11-point scale from 0 to 10, with 0 points for completely dissatisfied and 10 points for complete satisfaction. The higher the number, the more satisfactory it is. |
| serum cortisol level (μg/dL) before and after surgery | intraoprative and postoperative 24hours | To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction |
| Intraoperative remifentanil consumption,postoperative pain score | at 0, 1, 6, 12, and 24 hours postoperative | To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction |
| arterial pH before and after surgery | intraoprative and postoperative 24hours | To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction |
| blood glucose level (mg/dL) before and after surgery | intraoprative and postoperative 24hours | To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction |
| measurement of adequate analgesia (NRS <4) before and after surgery | intraoprative and postoperative 24hours | To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction |
| leukocyte level (10^3/μL) before and after surgery | intraoprative and postoperative 24hours | To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction |
Countries
South Korea
Contacts
Primary ContactYoungwon Kim
Outcome results
None listed