Optimizing Surgical Conditions During Laparoscopic Herniotomy With Deep Neuromuscular Blockade

Laparoscopic Herniotomy Clinical Trial

Official title:

Optimizing Surgical Conditions During Laparoscopic Umbilical, Incisional -and Linea Alba Herniotomy With Deep Neuromuscular Blockade

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02247466
• Other study ID #: NMBDKHernia2014
• Status: Completed
• Phase: Phase 4
• Start date: February 2015
• Est. completion date: February 23, 2017

Study information

• Verified date: June 2019
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate surgical work space and surgical conditions in patients scheduled for laparoscopic umbilical, -linea alba and incisional herniotomy. The patients will act as their own control with evaluation of surgical work space and surgical conditions during both deep NMB and no NMB.

Description:

Umbilical herniotomy is a frequent surgical procedure worldwide, and the larger hernia defects are preferably operated by laparoscopic technique. The advantages of the laparoscopic approach are shorter convalescence with earlier mobilization, and less wound complications [1]. A preferred approach is currently to close the defect by laparoscopic suturing in order to reduce the formation of seroma in the hernia sac [2] , and then apply a mesh by intraperitoneal onlay technique (IPOM technique). However, it may be difficult to suture the defect if there is tension in the abdominal wall muscles together with the applied pneumoperitoneum.

There is evidence that muscle relaxation improves conditions for endotracheal intubation[3] and reduces laryngeal morbidity but only a few studies investigate the necessity of relaxation during laparoscopic surgery [4].

During laparoscopic surgery muscle relaxation is used with great variability. Sometimes the procedure is performed without muscle relaxation and sometimes with a so-called surgical neuromuscular blockade, which with objective neuromuscular monitoring means that train-of-four (TOF) is kept at 3-4 responses to nerve stimulation of the ulnar nerve. In this way there is a great variability in the neuromuscular blockade and rarely the patients are receiving deep neuromuscular blockade.

Traditionally, neuromuscular monitoring is done by measuring the muscle strength of the adductor pollicis muscle on the thumb. The response to TOF nerve stimulation may be zero, while muscle relaxation of more resistant muscles such as the abdominal muscles and the diaphragm [5;6] are not complete which means that the patients may cough and their abdominal wall may feel "tight" during surgery, even though no response at the thumb is recorded. It is possible to quantify a deep neuromuscular block by the use of post-tetanic-count (PTC). With establishment of deep, continuous neuromuscular blockade with PTC value 0-1 all muscles including abdominal muscles and diaphragm are paralyzed [7]. It is therefore possible, that a deep neuromuscular blockade (NMB) where the diaphragm and the abdominal wall muscles are more paralyzed will optimize the surgical work space, ease the surgical procedure, reduce operative time for the suturing part of the procedure as well as the total procedure time, and reduce the number of recurrences by long term follow-up.

The purpose of this study is to investigate surgical work space and surgical conditions in patients scheduled for laparoscopic umbilical, -linea alba and incisional herniotomy. The patients will act as their own control with evaluation of surgical work space and surgical conditions during both deep NMB and no NMB.

Hypothesis:

Deep NMB defined as TOF=0 and post-tetanic count PTC ≥1, will give better surgical workspace, better surgical conditions, as well as shorter duration of surgery and reduced number of recurrences of hernias compared with no NMB.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: February 23, 2017
• Est. primary completion date: February 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients > 18 years old

• Elective laparoscopic umbilical herniotomy, incisional herniotomy and linea alba - herniotomy

• Can read and understand Danish

• Informed consent

Exclusion Criteria:

• Known allergy to sugammadex, rocuronium or mivacurium

• Known homozygous variants in the butyrylcholinesterase gene

• Severe renal disease, defined by S-creatinine> 0.200 mmol/L, GFR < 30ml/min or hemodialysis)

• Neuromuscular disease that may interfere with neuromuscular data

• Lactating or pregnant (Women of child bearing potential must take a urine pregnancy test at the day of the operation. The test will be provided by the hospital staff).

• Indication for rapid sequence induction

Related Conditions & MeSH terms

• Laparoscopic Herniotomy

Intervention

Drug:
• Rocuronium and Sugammadex

Locations

Country	Name	City	State
Denmark	Gentofte Hospital	Hellerup	Region Hovedstaden
Denmark	Herlev Hospital	Herlev	Region Hovedstaden

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of Surgical Workspace	Improvement of surgical workspace (rated on a 5-point scale) estimated as the difference between the workspace during deep NMB and the workspace without NMB. Ratings are performed in the same patient during stable pneumoperitoneum at 12 mmHg.; (1 Extremely poor conditions; 2 Poor conditions; 3 Acceptable conditions; 4 Good conditions; 5 Optimal conditions)	3 hours
Secondary	Surgical Conditions While Suturing	Surgeon´s rating of surgical conditions while suturing the hernia (5-point rating scale); (1 Extremely poor conditions; 2 Poor conditions; 3 Acceptable conditions; 4 Good conditions; 5 Optimal conditions)	3 hours
Secondary	Operating Time	Duration of operating time (from first incision to last suture)	3 hours
Secondary	Suturing Time	Duration of suturing the hernia (minutes)	3 hours
Secondary	Contractions	Sudden contractions of the abdominal wall during operation (bucking or coughing), number of participants with sudden contractions	3 hours
Secondary	Insufflator Alarms	Insufflator alarms where pneumoperitoneum > 17 mmHg Number of patients experiencing insufflator alarms where pneumoperitoneum > 17 mmHg	3 hours
Secondary	Continuous Abdominal Contractions	Number of patients experiencing episodes with continuous abdominal contractions where the abdomen feels "tight" but the operation can still proceed (the intestines are gradually displaced near the inner surface of the abdominal wall)	3 hours
Secondary	Recurrences of Hernias	Number of recurrences of hernias by 2 year follow-up (separate publication).	2 years