Efficacy of Ultrasound Guided Rectus Sheath Block on Post Operative Quality of Recovery

August 12, 2022 updated by: Ayman Abougabal, Kasr El Aini Hospital

Efficacy of Ultrasound Guided Rectus Sheath Block Combined With General Anaesthesia on the Postoperative Quality of Recovery Profile in Laparotomy Surgeries, Randomized Control Trial.

Effective Postoperative pain management following laparotomy represents a cornerstone in the care of surgical patients. With the growing utilization of Enhanced recovery after surgery protocols (ERAS), a paradigm shift in perioperative care has resulted in reduction of both hospital stay and clinical complications faced by patients.

One important component of successful implementation of ERAS protocol is optimized pain control. It has been shown that opioids have a considerable role in reducing bowel motility in addition; it hinders early mobilization and enteral feeding besides their commonly faced side effects such as nausea and vomiting.

Consequently, ERAS programs encourage the usage of multimodal opioid sparing analgesia which includes neuraxial or regional anesthesia techniques to provide effective pain relief while reducing the opioid related side effects. [1]

Regional blocks have remained popular with evidence of superior postoperative pain control when compared with systemic analgesics. Regional anaesthesia techniques have undergone considerable refinement with the advent of ultrasound guidance. Ultrasound visualization of anatomical structures increases both the safety and quality of regional blocks through optimal needle placement. Ultrasound-guided rectus sheath (RS) blocks are an emerging anaesthetic technique providing excellent analgesia after laparotomy. The anatomic characteristics of this block suggest minimal serious complications are likely, and this regional block is particularly useful where epidural is contraindicated

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12566
        • Kasr Alainy medical school

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18-60 years old patients
  2. ASA 1-2 patients
  3. Patients undergoing elective midline laparotomy.

Exclusion Criteria:

  • 1. refusal to consent, 2. previous laparotomy (subsequently amended to exclude only a laparotomy with a paramedian scar), 3. significant hepatic or renal disease, 4. any condition limiting the use of co-analgesics (diclofenac and acetaminophen), 5. coagulopathy (international normalized ratio: 1.5 ) 6. Patients with body weight \ 50 kg.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Control
Procedure: rectus sheath block
blocking the nerve underneath the rectus muscle by bupivicaine
ACTIVE_COMPARATOR: Rectus sheath block
Procedure: rectus sheath block
blocking the nerve underneath the rectus muscle by bupivicaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of recovery
Time Frame: 24 hours
using QOR-15 questionnaire
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2022

Primary Completion (ACTUAL)

June 1, 2022

Study Completion (ACTUAL)

June 1, 2022

Study Registration Dates

First Submitted

February 11, 2022

First Submitted That Met QC Criteria

February 11, 2022

First Posted (ACTUAL)

February 17, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 15, 2022

Last Update Submitted That Met QC Criteria

August 12, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-202-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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