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

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: postoperative 0.5% Ropivacaine hydrochloride; Drug: preoperative 0.5% ropivacaine hydrochloride preoperative

• Registration Number: NCT02477098
• Lead Sponsor: China Medical University, China

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.

Study Timeline

• Study First Submitted: 2015-06-15
• Study First Submitted QC: 2015-06-19
• Study First Posted: 2015-06-22
• Study Start: 2015-10
• Status Verified: 2016-06
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-06-17
• Last Update Posted: 2016-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 77

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post RSB	postoperative 0.5% Ropivacaine hydrochloride	patients who receive preoperative rectus sheath block of saline and receive postoperative rectus sheath block of Ropivacaine hydrochloride
Pre RSB	preoperative 0.5% ropivacaine hydrochloride preoperative	patients who receive preoperative rectus sheath block of ropivacaine hydrochloride and receive postoperative rectus sheath block of saline

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

the First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China