Postoperative Pain
Conditions
Keywords
rectus sheath block, cytokines, sleep
Brief summary
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
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.
Interventions
DRUGpreoperative 0.5% ropivacaine hydrochloride preoperative
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.
DRUGpostoperative 0.5% Ropivacaine hydrochloride
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.
Sponsors
China Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the interval between leaving the post-anaesthesia care unit (PACU) and receiving the first PCIA bolus injection | postoperative 24 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pain | postoperative 24 hours | cumulative oxycodone consumption at 24 h after surgery between patients who receive preoperative versus postoperative RSB |
| postoperative sleep quality | postoperative 24 hours | postoperative sleep quality, which will be measured using a BIS-Vista monitor during the first night after surgery |
| cytokine levels | postoperative 24 and 48 hours | c)cytokine levels (interleukin-6, tumour necrosis factor-α, interleukin-1 and interferon-gamma ) during the operation and at 24 and 48 hours postoperatively. |
Countries
China
Outcome results
None listed