Clinical trial NCT02477098: Preoperative Versus Postoperative Ultrasound-guided Rectus Sheath Block for Sleep Quality and Cytokines of Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: rectus sheath block
cytokines
sleep
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2015-06-22
Enrollment: 77
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: the interval between leaving the post-anaesthesia care unit (PACU) and receiving the first PCIA bolus injection
timeFrame: postoperative 24 hours
Secondary outcomes:
measure: postoperative pain
timeFrame: postoperative 24 hours
measure: postoperative sleep quality
timeFrame: postoperative 24 hours
measure: cytokine levels
timeFrame: postoperative 24 and 48 hours
Other outcomes:
Locations:
city: Shenyang
country: China
facility: the First Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: First Hospital of China Medical University
name: Wen-fei Tan, M.D.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jin F, Li Z, Tan WF, Ma H, Li XQ, Lu HW. Preoperative versus postoperative ultrasound-guided rectus sheath block for improving pain, sleep quality and cytokine levels in patients with open midline incisions undergoing transabdominal gynecological surgery: a randomized-controlled trial. BMC Anesthesiol. 2018 Feb 9;18(1):19. doi: 10.1186/s12871-018-0485-9.
citation: Jin F, Li XQ, Tan WF, Ma H, Lu HW. 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: study protocol for a randomised controlled trial. Trials. 2015 Dec 10;16:568. doi: 10.1186/s13063-015-1096-0.