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

NCT05244746 | Completed

• 1 other identifier: MS-202-2021
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• quality of recovery

  using QOR-15 questionnaire

  24 hours

Study Arms (2)

Rectus sheath block

ACTIVE COMPARATOR

Procedure: rectus sheath block

Control

PLACEBO COMPARATOR

Procedure: rectus sheath block

Interventions

rectus sheath block PROCEDURE

blocking the nerve underneath the rectus muscle by bupivicaine

Control; Rectus sheath block

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old patients
• ASA 1-2 patients
• Patients undergoing elective midline laparotomy.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr alainy medical school

Cairo, 12566, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A abougabal

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: February 17, 2022
• Study Start: March 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: August 15, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)