Preoperative Versus Postoperative Ultrasound-guided Rectus Sheath Block for Sleep Quality and Cytokines of Patients

Study Overview
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Brief Summary
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Rectus sheath block (RSB) is used for postoperative pain relief in patients undergoing abdominal surgery with a midline incision. It has proved to be effective in preoperative block, but it has not been previously compared with postoperative block. The aim of the present study is to evaluate postoperative pain, sleep quality and changes in the cytokine levels of patients undergoing gynaecological surgery with RSB performed preoperatively versus postoperatively.

Detailed Description
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Rectus sheath block (RSB) is used for postoperative pain relief in patients undergoing abdominal surgery with a midline incision. It has proved to be effective in preoperative block, but it has not been previously compared with postoperative block. The aim of the present work is to evaluate the postoperative sleep quality and changes in cytokines of patients undergoing gynaecological operation with RSB preoperatively or postoperatively. Methods/Design This study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All patients undergoing transabdominal gynaecological operation will be randomized 1:1 to the treatment intervention with general anaesthesia as an adjunct to RSB preoperatively or postoperatively. The objective of the trial is to evaluate the postoperative sleep quality and changes in cytokines of patients undergoing hysterectomy with RSB preoperatively (n=32) or postoperatively (n=32). All of the patients, irrespective of group allocation, will receive patient-controlled intravenous analgesia with oxycodone. The primary objective is to compare the interval between leaving the post-anaesthesia care unit and receiving the first PCIA bolus injection on the first postoperative night between patients who receive preoperative versus postoperative RSB. The secondary objectives will be to compare (1) cumulative oxycodone consumption at 24 h after surgery; (2) postoperative sleep quality, as measured using a BIS-Vista monitor during the first night after surgery; and (3) cytokine levels (interleukin-1, interleukin-6, tumour necrosis factor-α and interferon-gamma) during surgery and at 24 and 48 h postoperatively.

Official Title
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Preoperative Versus Postoperative Ultrasound-guided Rectus Sheath Block for Improving Pain, Sleep Quality and Cytokine Levels of Patients With Open Midline Incisions Undergoing Transabdominal Gynaecological Operation

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: preoperative 0.5% ropivacaine hydrochloride preoperative
* Drug: postoperative 0.5% Ropivacaine hydrochloride


Participation Criteria
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Eligibility Criteria
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The inclusion criteria are as follows: (1) an age of 18 to 65 years old; (2) scheduled to undergo elective midline incision transabdominal gynaecological surgery for benign mass; and (3) American Society of Anaesthesiologists (ASA) risk classification I-II. The exclusion criteria are as follows: (1) patient refusal; (2) known hypersensitivity to the study medication (ropivacaine); (3) long-term use of opioids; (4) liver or renal insufficiency; (5) a history of psychiatric or neurological disease; (6) deafness; (7) previous open surgery; (8) regular use of acetaminophen, nonsteroidal anti-inflammatory drugs, corticosteroids, or antiemetics; and (9) a preoperative Pittsburgh Sleep Quality Index (PSQI) global score of higher than 6

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre RSB<br>patients who receive preoperative rectus sheath block of ropivacaine hydrochloride and receive postoperative rectus sheath block of saline | Drug: preoperative 0.5% ropivacaine hydrochloride preoperative<br>* Before surgery (Pre RSB) , a bilateral RSB with ropivacaine hydrochloride will be performed under ultrasound guidance by one anaesthesiologist.At the end of surgery, a bilateral RSB with saline will be performed under ultrasound guidance by one anaesthesiologist.<br>* Other names: preoperative rectus sheath block of 0.5% Ropivacaine hydrochloride;|
| Experimental: Post RSB<br>patients who receive preoperative rectus sheath block of saline and receive postoperative rectus sheath block of Ropivacaine hydrochloride | Drug: postoperative 0.5% Ropivacaine hydrochloride<br>* Before surgery, a bilateral RSB with saline will be performed under ultrasound guidance by one anaesthesiologist.At the end of surgery, a bilateral RSB with ropivacaine hydrochloride will be performed under ultrasound guidance by one anaesthesiologist.<br>* Other names: Rectus sheath block of 0.5% Ropivacaine hydrochloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the interval between leaving the post-anaesthesia care unit (PACU) and receiving the first PCIA bolus injection | The primary objective is to compare the interval between leaving the post-anaesthesia care unit (PACU) and receiving the first PCIA bolus injection on the first postoperative night between patients who receive preoperative RSB and those who receive postoperative RSB. | postoperative 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | cumulative oxycodone consumption at 24 h after surgery between patients who receive preoperative versus postoperative RSB | postoperative 24 hours | 
| postoperative sleep quality | postoperative sleep quality, which will be measured using a BIS-Vista monitor during the first night after surgery | postoperative 24 hours | 
| cytokine levels | c)cytokine levels (interleukin-6, tumour necrosis factor-α, interleukin-1 and interferon-gamma ) during the operation and at 24 and 48 hours postoperatively. | postoperative 24 and 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rectus sheath block, cytokines, sleep