Deep Neuromuscular Block With Low Pressure Pneumoperitoneum in Laparoscopic Abdominal Surgeries

Deep Neuromuscular Block With Low Pressure Pneumoperitoneum in Laparoscopic Abdominal Surgeries: A Randomized Controlled Trial

The aim of this study is to evaluate the effect of deep neuromuscular block on postoperative pain, duration of surgery, quality of surgical field, length of recovery room stays, Total amount of rescue analgesic, postoperative nausea/vomiting, and length of hospital stay.

Study Overview

• Status: Recruiting
• Conditions: Pneumoperitoneum; Deep Neuromuscular Block; Low Pressure; Laparoscopic Abdominal Surgeries
• Intervention / Treatment: Other: Deep neuromuscular block; Other: Moderate neuromuscular block

Detailed Description

Acute-pain management in surgery patients is accompanied by an array of negative consequences, including increased morbidity, impaired physical function, and quality of life, slowed recovery, prolonged opioid use during and after hospitalization, and increased cost of care.

Reducing pneumo-peritoneum (PP) is one technique for reducing postoperative pain. The effect of low PP on postoperative pain remains a controversial topic with other studies reporting no difference in postoperative pain levels between the Two pressures.

Deep neuromuscular block (DNMB) in abdominal surgeries is associated with various advantages, such as lower abdominal pressure, lower pain and rescue opioid consumption, as well as less bleeding. DNMB may facilitate the use of reduced insufflation pressure without compromising the surgical field of vision. However, its usage is limited due to a lack of predictable and rapid recovery with conventional NMB antagonists (neostigmine) or spontaneous recovery

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed M Ibrahim, MD; Phone Number: 00201141779238; Email: ahmed.edib@med.tanta.edu.eg

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Recruiting
      • Tanta University
      • Principal Investigator: Rehab A Helal, MD
      • Contact: Ahmed M Ibrahim, Master; Phone Number: 00201141779238; Email: ahmed.edib@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 to 65 years old.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status I-III.
• Patients scheduled for laparoscopic abdominal surgery.

Exclusion Criteria:

• Known allergies to cis-atracurium or neostigmine.
• Contraindications to the use of neostigmine, such as bronchial asthma, glaucoma, myocardial ischemia, and epilepsy.
• History of neuromuscular, renal, or hepatic disease; previous abdominal surgery.
• Treatment with drugs known to affect neuromuscular function.
• Preoperative hyperalgesia.
• Peripheral neuropathy is caused by diabetes.
• History of chronic analgesics treatment, drug, or alcohol abuse.
• Body mass index (BMI) > 35 kg/m2.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deep neuromuscular block; Patients will receive deep neuromuscular block by using cis-atracurium	Other: Deep neuromuscular block; Patients will receive deep neuromuscular block by using cis-atracurium. After tracheal intubation for 15 min, a cis-atracurium pump will be started, and its rate will be adjusted to maintain a post-tetanic count (PTC) in the 1-2 range.
Other: Moderate neuromuscular block; Patients will receive moderate neuromuscular block by using cis-atracurium.	Other: Moderate neuromuscular block; Patients will receive moderate neuromuscular block by using cis-atracurium. Pump delivery of cis-atracurium will be started when the TOF count returned to 2. The TOF count is maintained between 1 and 3 by adjusting the pump rate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The degree of pain	The degree of pain will be evaluated using the numerical rating scale (NRS) from (0 to 10), zero means no pain and ten means the worst pain. It will be measured at PACU, 1h, 2h. 4hr, 6h, 8h, 12h, 18h, 24h, 36h and 48h postoperative.	48 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of first analgesic	Time of first analgesic will be measured from the end of surgery till first dose of morphine administrated. If numerical rating scale (NRS) is more than 3, intravenous morphine 3mg will be administered as rescue analgesia.	48 hours postoperatively
Total opioid consumption in 1st 48h	A standardized analgesic regimen will be prescribed in the post-operative period. All patients will receive paracetamol 1 gm every 6 h as routine analgesia. If numerical rating scale (NRS) is more than 3, intravenous morphine 3mg will be administered as rescue analgesia.	48 hours postoperatively
The degree of Patient satisfaction	The degree of patient satisfaction will be assessed on a 5-point scale: (0= extremely dissatisfied, 1= unsatisfied, 2= neither satisfied nor unsatisfied, 3= satisfied), 4= extremely satisfied).	48 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: January 27, 2024
• First Submitted That Met QC Criteria: January 27, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 3, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum
• Other Study ID Numbers: 36264PR461/12/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No