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Completed

NCT Number: NCT02477098

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

preoperative 0.5% ropivacaine hydrochloride preoperative

Drug

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.

Other names: preoperative rectus sheath block of 0.5% Ropivacaine hydrochloride

postoperative 0.5% Ropivacaine hydrochloride

Drug

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.

Other names: Rectus sheath block of 0.5% Ropivacaine hydrochloride

Primary outcomes

  1. the interval between leaving the post-anaesthesia care unit (PACU) and receiving the first PCIA bolus injection

    Time frame: 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 outcomes

  1. postoperative pain

    Time frame: postoperative 24 hours

    cumulative oxycodone consumption at 24 h after surgery between patients who receive preoperative versus postoperative RSB

  2. postoperative sleep quality

    Time frame: postoperative 24 hours

    postoperative sleep quality, which will be measured using a BIS-Vista monitor during the first night after surgery

  3. cytokine levels

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

China Medical University, China

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 22, 2015
Registry last updated
Jun 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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