Preoperative Versus Postoperative Ultrasound-guided Rectus Sheath Block for Sleep Quality and Cytokines of Patients
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): preoperative 0.5% ropivacaine hydrochloride preoperative; postoperative 0.5% Ropivacaine hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 intervention name(s): preoperative rectus sheath block of 0.5% Ropivacaine hydrochloride; Rectus sheath block of 0.5% Ropivacaine hydrochloride
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: rectus sheath block; cytokines; sleep