This prospective randomized observer-blinded controlled study was performed in National Cancer Institute of Cairo University "NCI-Cairo". The study was performed between February 2012 and December 2013. After approval of NCI-Cairo/IRB, written informed consents were obtained from all patients. Our study protocol recruited patients scheduled for elective surgeries for radical cancer resection needing extensive (extending from xiphisternum to symphysis pubis) midline incisions. Sixty patients with ASA (American Society of Anesthesiologists) physical status I-III, 18 to 75 years old, were randomly allocated to one of the following two groups with the intension to treat applied principles:
1) Combined general rectus sheath block anesthesia (group-RSB): where 20 mL of 0.25% bupivacaine in saline were injected into the rectus sheath plane on either sides under direct US visualization.
2) General anesthesia (group GA): where no RSB was performed.
Exclusion criteria were as follows: ASA physical status ≥ III; any contraindications to regional techniques (allergy to local anesthetics, infection around the site of the block, and coagulation disorder), history of analgesics dependence and any difficulty with communication.
The day before surgery, patients were instructed in the verbal analogue scale (VAS) score. The VAS scores with 0/10 representing no pain and 10/10 the worst imaginable pain. Patients were asked to score pain before operation on intravenous catheter insertion.
In the pre-surgical holding area, peripheral IV access was obtained, and all patients were pre-medicated with midazolam (3-5 mg IV) shortly before transfer to the operating room. Anesthesia was induced with fentanyl 2-3 µg/kg and propofol 2-2.5 mg/kg, IV route. An IV bolus of cisatracurium 0.1 mg/kg IV was given to facilitate tracheal intubation. After endotracheal intubation, patients were ventilated in a pressure-controlled volume guaranteed mode at tidal volumes less than 6 mL/kg, at respiratory rates to maintain end-tidal carbon dioxide concentration between 30–40 mmHg, with a positive end-expiratory pressure of 5 mmHg, and an inspired oxygen fraction (FIO2) of 0.6. Anesthesia was maintained with sevoflurane in oxygen and additional bolus doses of fentanyl 0.5–1 µg/kg to keep arterial pressure values around 20% below baseline values. Total intraoperative fentanyl consumption was recorded. After reversal of neuromuscular blocking agent and response to verbal command, patients were extubated in the operating theatre. They were then transferred to the PACU.
3.1. Rectus Sheath Block Technique
All rectus sheath blocks (RSB) were performed by one investigator in the operating room (OR) just after induction of anesthesia and before surgical incision. Basic intraoperative monitoring, according to ASA guidelines were used during the procedure and emergency equipment to respond to local anesthetic toxicity must be readily available. Complete aseptic technique was adopted.
The rectus muscle is imaged with the ultrasound probe in a transverse orientation at or immediately above the level of the umbilicus (
Figure 1). A broadband (5-12 MHz) linear array probe of eZono ™ 3000 ultrasound (eZono AG – Spitzweidenweg, Germany) was used, with an imaging depth of 4-6 cm.
Inserting the needle: An 18G Tuohy needle is introduced few millimeters from the probe using an in plane technique in an angle of approximately 45 degrees to the skin. The ultrasound image allowed identification of the rectus muscle and two hyperechoic railway-like lines deep in it (posterior rectus sheath and fascia transversalis) (
Figure 1). The small size of the somatic sensory nerve fibers; located in this plane typically prevents their visualization by US or localization by nerve stimulation.
R Ms: rectus abdominis muscle. Arrows: posterior rectus sheath.
Under direct vision, the needle tip was advanced to the desired position where 20 mL bupivacaine 0.25% were injected causing hydrodissection of the rectus muscle away from the posterior rectus sheath (
Figure 2). The technique is repeated on the opposite side.
R Ms: rectus abdominis muscle. Arrows: posterior rectus sheath. LA: local anesthetic.
In the PACU,
•All patients received IV infusions of paracetamol (Perfalgan) (15 mg/kg administered over 20 minutes then continued every 8 hours) and liometacen on request.
•Both groups had pain assessment when sufficiently awake for it, and IV morphine titration were performed by an attending anesthesiologist blinded to group allocation.
•Subsequently VAS pain scores were recorded every 15 minutes, in the PACU till discharge from it to the surgical ward. In the surgical ward VAS pain scores were assessed every 6 hours during the day of surgery (POD0) and next 2 days (POD1 and POD2).
•When the VAS score exceeded 3/10, IV Morphine 1-2 mg was administered and repeated at 5 minutes intervals until the VAS score decreased to < 3/10 at rest, and morphine consumption were recorded in the PACU, on POD0, POD1, and POD2.
•Respiratory rate, heart rate, and arterial pressure were recorded every 30 minutes, in the PACU and then every 2 hours after discharge to the ward. Respiratory depression was defined as a respiratory rate < 8 bpm.
•Patient sedation was assessed on a 5-point sedation Ramsay's score (1, wide awake; 2, drowsy or dozing intermittently; 3, mostly sleeping but easily awakened; 4, asleep, difficulty responding to verbal commands; 5, awakened only by shaking) (
15) Oversedation was defined as having a sedation score > 4 combined with a respiratory rate < 8 bpm.
•Any incidence of nausea and vomiting PONV were also recorded where 0 = no nausea or vomiting, 1 = nausea, 2 = vomiting.
The primary outcome measures were pain intensities assessed by VAS score. Secondary outcome measures included consumption of IV morphine and incidence of respiratory depression, degree of sedation, nausea and vomiting.
3.2. Statistical Analyses
The data were expressed as mean ± standard deviation in normally distributed data. Statistical analysis was performed by independent t test for determining intergroup comparison and paired t test for intragroup difference. Data were expressed as median (interquartile range). Statistical analysis was performed using the Mann–Whitney U test for determining intergroup comparison. Chi-square test was used for categorical data. P ˂ 0.05 was considered statistically significant. SPSS 15.0 version was used for all the analysis.