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Completed

NCT Number: NCT02660632

Epidural Block vs. Rectus Sheath Block on Postoperative Pulmonary Function

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.

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Key information

Conditions

Abdominal Surgeries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university

Al Mansurah, DK, 050, Egypt

About this study

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.

  • Induction of anesthesia: propofol 1.5-2.5 mg kg-1.
  • Muscle Relaxants: rocuronium 0.6 mg kg-1 for induction.
  • Maintenance: Sevoflurane 0.7-1.5 MAC vaporized in air-oxygen (40% inspired fraction).

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiologists physical class I to III.
  • Patients scheduled for elective midline laparotomy.

Exclusion criteria

  • Morbid obese patients.
  • Severe or uncompensated cardiovascular disease.
  • Significant renal disease.
  • Significant hepatic disease.
  • Pregnancy.
  • Lactating.
  • Allergy to the study medications.
  • Psychological disorder.
  • Neurological disorder.
  • Communication barrier.
  • Mental disorders.
  • Epilepsy.
  • FEV1 or FEV1/FVC ratio less than 50%, dyspnea with a New York Heart Association class IV.
  • Drug or alcohol abuse.
  • Contraindications to epidural anaesthesia.
  • Opioid analgesic medication within 24 h before the operation.

Treatment and study plan

Thoracic Epidural Analgesia (TEA)

Other

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

Rectus sheath catheter block

Other

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.

Primary outcomes

  1. Changes in forced expiratory volume in 1 second (FEV1)

    Time frame: Before and for 72 hours after surgery

  2. 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

Secondary outcomes

  1. Changes in arterial blood gases

    Time frame: Before and for 72 hours after surgery

  2. Visual analog pain scores

    Time frame: for 48 hours after surgery

    Postoperative pain will be assessed on rest and with cough and during movements for both of visceral and parietal pain

  3. Sedation score

    Time frame: for 48 hours after surgery

    Sedation scores using a sedation scale (awake and alert= 0; quietly awake= 1; asleep but easily roused= 2; deep sleep= 3.

  4. Postoperative nausea and vomiting

    Time frame: for 48 hours after surgery

    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

  5. Return of bowel function

    Time frame: for 72 hours after surgery

    The times to first flatus, defecation, intake of clear liquid and solid food tolerance

  6. Time to hospital discharge

    Time frame: for 15 days after surgery

    from the end of anesthesia

  7. Cumulative tramadol use

    Time frame: For 48 hours after surgery

  8. Overall patient's satisfaction

    Time frame: For 48 hours after surgery

    Patient overall satisfaction will be assessed before hospital discharge using the visual analog score

  9. Intraoperative use of ephedrine

    Time frame: For 5 hours after induction of anesthesia

  10. Postoperative cardio-respiratory complications

    Time frame: For 7 days after surgery

  11. Postoperative wound infection

    Time frame: For 21 days after surgery

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Effect of Thoracic Epidural Analgesia vs Rectus Sheath Catheters on Postoperative Pulmonary Function After Midline Laparotomy: A Prospective Randomized Controlled Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 21, 2016
Registry last updated
Jun 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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