NCT02477098

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for phase_4 postoperative-pain

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 22, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 20, 2016

Status Verified

June 1, 2016

Enrollment Period

8 months

First QC Date

June 15, 2015

Last Update Submit

June 17, 2016

Conditions

Postoperative Pain

Keywords

rectus sheath blockcytokinessleep

Outcome Measures

Primary Outcomes (1)

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

    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.

    postoperative 24 hours

Secondary Outcomes (3)

  • postoperative pain

    postoperative 24 hours

  • postoperative sleep quality

    postoperative 24 hours

  • cytokine levels

    postoperative 24 and 48 hours

Study Arms (2)

Pre RSB

EXPERIMENTAL

patients who receive preoperative rectus sheath block of ropivacaine hydrochloride and receive postoperative rectus sheath block of saline

Drug: preoperative 0.5% ropivacaine hydrochloride preoperative

Post RSB

EXPERIMENTAL

patients who receive preoperative rectus sheath block of saline and receive postoperative rectus sheath block of Ropivacaine hydrochloride

Drug: postoperative 0.5% Ropivacaine hydrochloride

Interventions

preoperative 0.5% ropivacaine hydrochloride preoperativeDRUG

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.

Also known as: preoperative rectus sheath block of 0.5% Ropivacaine hydrochloride
Pre RSB
postoperative 0.5% Ropivacaine hydrochlorideDRUG

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.

Also known as: Rectus sheath block of 0.5% Ropivacaine hydrochloride
Post RSB

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Related Publications (2)

  • 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.

    PMID: 29426287DERIVED

  • 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.

    PMID: 26652009DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

RopivacainePostoperative Period

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPerioperative PeriodSurgical Procedures, OperativePatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Wen-fei Tan, M.D.,Ph.D

    First Hospital of China Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

June 15, 2015

First Posted

June 22, 2015

Study Start

October 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 20, 2016

Record last verified: 2016-06

Locations

CN(1)