Effect of Preoperative Rectus Sheath Block on Quality of Recovery in Single Port Laparoscopic Adnexal Surgery

Study Overview
=================
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.

Official Title
-----------------
Effect of Preoperative Rectus Sheath Block on Quality of Recovery in Single Port Laparoscopic Adnexal Surgery: A Randomized Controlled Trial

Conditions
-----------------
Single Port Laparoscopic Adnexal Surgery

Intervention / Treatment
-----------------
* Drug: Ultrasound guided rectus sheath block with dexmedetomidine
* Drug: Ultrasound guided rectus sheath block with normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexmedetomidine infusion group<br> | Drug: Ultrasound guided rectus sheath block with dexmedetomidine<br>* Intervention Group: Ultrasound guided rectus sheath block with 0.5% ropivacaine 20ml at each side (bilateral)<br>|
| Placebo Comparator: normal saline infusion group<br> | Drug: Ultrasound guided rectus sheath block with normal saline<br>* Control Group: Ultrasound guided rectus sheath block with 0.9% normal saline 20ml at each side (bilateral)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Recovery 40 scale score at postoperative 24 hour | Postoperative quality of recovery according to the block performance | 24 hours after the end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative remifentanil consumption,postoperative pain score | To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction | at 0, 1, 6, 12, and 24 hours postoperative | 
| rescue analgesics administered up to 24 hours postoperatively | To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction | intraoprative and postoperative 24hours | 
| satisfaction with pain control | 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. | intraoprative and postoperative 24hours | 
| serum cortisol level (μg/dL) before and after surgery | To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction | intraoprative and postoperative 24hours | 
| leukocyte level (10^3/μL) before and after surgery | To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction | intraoprative and postoperative 24hours | 
| arterial pH before and after surgery | To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction | intraoprative and postoperative 24hours | 
| blood glucose level (mg/dL) before and after surgery | To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction | intraoprative and postoperative 24hours | 
| measurement of adequate analgesia (NRS <4) before and after surgery | To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction | intraoprative and postoperative 24hours |