An interventional study of Thoracic epidural analgesia (TEA) and Rectus sheath catheter block in Abdominal Surgeries, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-06-08.
Sponsored by Mansoura University · Not applicable, Interventional, and Prevention
Pulmonary complications are among the most important postoperative complications after midline incisions, for which different analgesic modalities have been tried.
Epidural analgesia is the recommended technique to relieve pain after major abdominal surgery owing to the proved superior analgesia, reduction of opioid related side effects as nausea, vomiting, pruritis and sedation, earlier recovery of bowel function and earlier ability for postoperative mobility However, it is not without complications.
Rectus sheath block provides several advantages over epidural anesthesia. It lessens the potential risks associated with neuraxial techniques, so it may represent a novel alternative approach for somatic analgesia after major abdominal surgeries. Although patients with rectus sheath block may experience some visceral pain, it is usually minimal by 24 hours after surgery.
The aim of this study is to compare the effects of thoracic epidural analgesia and rectus sheath blockade on postoperative pulmonary functions, pain scores, duration of analgesia, sedation scores, patients' satisfaction and adverse effects.
FEV1, FEV1/FVC ratio will be measured by a bed side spirometer.
Radial artery catheterization: under complete aseptic conditions 20G cannula will be inserted into the radial artery of non-dominant hand after performing modified Allen's test and local infiltration of 0.5ml xylocaine 2% .
Thoracic epidural catheter will be inserted before induction of general anaesthesia under aseptic insertion conditions and using loss of resistance to air technique with the patient in the sitting position at T9- T11 interspaces.
The Rectus sheath catheters will be inserted bilaterally using ultrasound (SonoSite M-Turbo®, Sonosite , USA) guidance as described by Webster after induction of general anaesthesia.
Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Patients who will be subjected for midline laparotomy, will receive epidural analgesia through an inserted thoracic epidural catheter before induction of general anesthesia
Other: Thoracic epidural analgesia (TEA)
After insertion of bilateral rectus sheath catheters, 20 ml of 0.25% bupivacaine will be injected on each side, then continuous infusion pumps will be connected to the catheters and set to deliver boluses of 20 mL of 0.25% bupivacaine, with a 4-hour lockout for up to 48 h postoperatively.
Other: Rectus sheath catheter block
Epidural catheter will be inserted at T9-T11. Then, epidural analgesia will be activated with administering bolus of 10 mls 0.25% bupivacaine in conjunction with100 mcg fentanyl to establish a block. This will be followed by an infusion of 0.125% bupivacaine in conjunction with 2 mcg/ ml fentanyl at a rate of 10 mls /hour and then titrated to effect for up to 48 hour postoperative
Following insertion of bilateral rectus sheath catheters, 20 ml of 0.25% bupivacaine will be injected through each one. Then continuous infusion pumps will be connected to the catheters and set to deliver boluses of 20 mL of 0.25% bupivacaine, with a 4-hour lockout for up to 48 h postoperatively.
Changes in forced expiratory volume in 1 second (FEV1)
Time frame: Before and for 72 hours after surgery
Changes in ratio between forced expiratory volume in 1 s and forced vital capacity (FEV1/FVC)
Time frame: Before and for 72 hours after surgery
Changes in arterial blood gases
Time frame: Before and for 72 hours after surgery
Visual analog pain scores
Postoperative pain will be assessed on rest and with cough and during movements for both of visceral and parietal pain
Time frame: for 48 hours after surgery
Sedation score
Sedation scores using a sedation scale (awake and alert= 0; quietly awake= 1; asleep but easily roused= 2; deep sleep= 3.
Time frame: for 48 hours after surgery
Postoperative nausea and vomiting
The degree of nausea and vomiting. Nausea will be measured using a numerical rating system (none= 0; mild= 1; moderate= 2; severe= 3). The number of vomiting episodes and the number of anti-emetics received
Time frame: for 48 hours after surgery
Return of bowel function
The times to first flatus, defecation, intake of clear liquid and solid food tolerance
Time frame: for 72 hours after surgery
Time to hospital discharge
from the end of anesthesia
Time frame: for 15 days after surgery
Cumulative tramadol use
Time frame: For 48 hours after surgery
Overall patient's satisfaction
Patient overall satisfaction will be assessed before hospital discharge using the visual analog score
Time frame: For 48 hours after surgery
Intraoperative use of ephedrine
Time frame: For 5 hours after induction of anesthesia
Postoperative cardio-respiratory complications
Time frame: For 7 days after surgery
Postoperative wound infection
Time frame: For 21 days after surgery
Plan to share: Undecided
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Mansoura University