Ultrasound Guided Rectus Sheath Block in Pediatric Single Port Laparoscopic Appendectomy

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04838379
Collaborator
(none)
60
2
16

Study Details

Study Description

Brief Summary

The current study aimed to assess the analgesic effect of ultrasound guided RSB with dexmedetomidine in the perioperative period of the surgical site after appendectomy In comparing only the postoperative outcome

Condition or Disease Intervention/Treatment Phase
  • Procedure: Ultrasound guided rectus sheath block
N/A

Detailed Description

laparoscopic appendectomy is one of the most frequently performed pediatric surgeries. Although minimally invasive, this technique is still associated with a significant amount of pain and anxiety in children . Indeed, children who are highly anxious prior to surgery tend to have more postoperative pain, delayed hospital discharge, and higher incidence of emergence delirium, sleep disturbances, and other mal-adaptive behavior changes that can last up to a few weeks following surgery . To improve analgesia and decrease postoperative anxiety in children undergoing laparoscopic appendectomies multimodal approach for pain control can be employee; Over the past years, the concept of pain management has extended from simply decreasing pain intensity to optimizing patient's condition. The goal is to decrease pain scores, stress response that should be avoided in patients, particularly cardiac patients, together with a decrease in analgesics-related adverse effects like nausea, vomiting, retention of urine and over sedation. By achieving these goals, we can certainly facilitate patient recovery and minimize the hospital stay. Improved pain control can be achieved by a combination of different types of regional analgesia with systemic analgesics. The main contributor to pain post abdominal operations is the pain from abdominal wall incision .

Many procedures were followed to decrease this intense postoperative pain such as, epidural catheter analgesia, Transverse Abdominis Plane (TAP) block, local wound infiltration, Patient-Controlled Analgesia (PCA), peripheral nerve blocks, in addition to Systemic administration of Non-Steroidal Anti- Inflammatory Drugs (NSAIDs) or opioids.

The Rectus Sheath Block (RSB) is one of these regional techniques that are suitable for operations with a midline incision or laparoscopic surgery with the main incision at the umbilical port. A previous study showed the analgesic efficacy of ultrasound guided rectus sheath block for laparoscopic appendectomy compared to a control group injected with saline instead of a local anesthetic in addition to the usefulness of traditional local anesthetics to provide analgesia during the course of the postoperative period is restricted by their short duration of action. Dexmedetomidine (DEX) has been shown as a valuable additive to local anesthetics in neuraxial blocks and peripheral nerve blocks leading to prolongation of postoperative analgesia and better pain control .

. dexmedetomidine (DEX) α-2 adrenergic receptor consists of three α-2 isoacceptors (α-2a, α-2b and α-2c), which regulate the various pharmacodynamic effects of this drug . The α-2a receptor seems to promote sedation and anxiolysis in the locus coeruleus, as well as to generate bradycardia and peripheral vasodilation by stimulation of the cerebral vasomotor center. The α-2b receptor prevents tremor, generates analgesia in the dorsal horns of the spinal cord and determines peripheral vasoconstriction. The α-2c receptor modulates the mental stat.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Age: 3-8years. Weight: 10-60 kg. Sex: both males and females. ASA physical status: I-II.Age: 3-8years. Weight: 10-60 kg. Sex: both males and females. ASA physical status: I-II.
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Ultrasound Guided Rectus Sheath Block by Bupivacaine With or Without Dexmedetomidine in Pediatric Single Port Laparoscopic Appendectomy
Anticipated Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: group Bupivacaine

will include 30 patients: each one will receive 2.5 mg/kg of 0.25% bupivacaine diluted in a 20 mL syringe of normal saline , 10 minutes before skin incision

Procedure: Ultrasound guided rectus sheath block
Sixty patients were randomized to receive ultrasound-guided RSB After the induction of anesthesia and patient stabilization, the abdomen was sterilized and draped. Then, under complete aseptic conditions, ultrasound-guided Bilateral Rectus Sheath Block (BRSB) was performed

Active Comparator: group bupivacaine&dex

2 will include 30 patients: each one will receive 2.5mg/kg of 0.25% bupivacaine plus 2 µ/kg of dexmedetomidine diluted in a 20 mL syringe of normal saline , 10 minutes before skin incision

Procedure: Ultrasound guided rectus sheath block
Sixty patients were randomized to receive ultrasound-guided RSB After the induction of anesthesia and patient stabilization, the abdomen was sterilized and draped. Then, under complete aseptic conditions, ultrasound-guided Bilateral Rectus Sheath Block (BRSB) was performed

Outcome Measures

Primary Outcome Measures

  1. evaluate the first call for rescue analgesia [24 hours after recovery from anesthesia]

    the time of the first call for analgesia is recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 8 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • ● Age: 3-8years.

  • Weight: 10-60 kg.

  • Sex: both males and females.

  • ASA physical status: I-II.

Exclusion Criteria:
  • • Patient's guardian refusal to participate in the study.

  • Patients having known hypersensitivity to dexametomidine will be excluded.

  • Patients with cardiovascular, liver or renal disease, unsatisfactory preoperative peripheral arterial oxygen saturation, neurological or psychiatric disease and coagulation disturbances.

  • Any perioperative cardiovascular or respiratory event occurred or difficulties in pain perception and assessment which make the study intervention clinically unacceptable.

  • Patients on regular use of analgesic or who received analgesic 24 h before surgery

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kirolos Gamal Reda, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT04838379
Other Study ID Numbers:
  • 01210861577
First Posted:
Apr 9, 2021
Last Update Posted:
Apr 13, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kirolos Gamal Reda, Principal Investigator, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 13, 2021