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NCT Number: NCT02031510

Dexmedetomidine in Transversus Abdominis Plane Block for Laparoscopic Cholecystectomy

The use of dexmedetomidine as an adjunct to bupivacaine in transversus abdominis plane block will reduce the cumulative morphine consumption after laparoscopic cholecystectomy.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Dammam University, Khobar, Eastern Province, Saudi Arabia

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About this study

Laparoscopic cholecystectomy, which is a common surgical procedure, is associated with less postoperative pain in comparison to open cholecystectomy. However, this pain needs to be treated adequately to allow early mobilization.

Ultrasound guided transversus abdominis plane (TAP) block is an established technique to manage post laparoscopic cholecystectomy pain. 1 In addition, the use of TAP blocks reduced the need for intraoperative and postoperative opioids and the side-effects associated with their use.

The aim of a TAP block is to deposit local anaesthetic in the plane between the internal oblique and transversus abdominis muscles targeting the spinal nerves in this plane. The innervation to abdominal skin, muscles and parietal peritoneum will be interrupted.

Dexmedetomidine which is an Alpha 2-adrenergic agonist produces analgesia via a non-opioid mechanism and is also known to enhance central and peripheral neural blockades.2 Dexmedetomidine added to bupivacaine or levobupivacaine for brachial plexus block shortens sensory and motor block onset time, extends motor and sensory block durations, and also extends the postoperative analgesia.3, 4

We postulate that the use of dexmedetomidine as an adjunct to bupivacaine in transversus abdominis plane block will reduce the morphine consumption after laparoscopic cholecystectomy.

Based upon previous published data,4 a priori power analysis indicated that 60 patients in each group would be sufficient to detect a 30% reduction in the 24-hours cumulative morphine consumption, which is considered to be of clinical validity, with a type-I error of 0.0167 (0.05/4) and a power of 80%. We added 10% extra patients to compensate for possible dropouts.

All patients will be familiarized with a 10-cm visual analogue scale (VAS) (0= no pain; 10= worst imaginable) to assess the intensity of pain and on the use of the patient-controlled analgesia (PCA).

Monitoring includes non-invasive blood pressure, and electrocardiography, pulse oximetry.

An intravenous infusion of 10 ml kg-1 of Lactated Ringer's solution will be initiated before surgery and will be followed by 5 ml kg-1 hr-1 throughout the procedure.

Anaesthesia technique will be standardized. Anesthesia will be induced by fentanyl of 2-3 µg kg-1, propofol 1.5-2.5 mg kg-1, and rocuronium 0.6 mg kg-1. Tracheal intubation will be carried out at the development of maximum block as monitored by the train-of-four (TOF).

Anesthesia, consisting of a 0.7-1.5 minimum alveolar concentration (MAC) of sevoflurane, will be administered to maintain heart rate (HR) and mean arterial blood pressure (MAP) values below 20% of baseline values. Fentanyl 0.5μg/kg increments will be administered when the HR and MAP values are > 20% of baseline values, despite a target sevoflurane of MAC ≥ 1.5. When the HR and MAP values < 20% of baseline values, the sevoflurane MAC is decreased gradually to 0.7 MAC.

Patients' lungs will be ventilated to achieve a PaCO2 of 35-45 mm Hg. All patients will receive intravenous granisetron 1 mg and lornoxicam 16 mg after the induction of anaesthesia. Rocuronium increments will be given to maintain suppression of the second twitch in the TOF.

The anaesthesiologists who will perform the TAP block and give the anaesthetics will not be involved in the patients' assessment. All other staff in the operating room is unaware of the randomization code.

The TAP block will be performed using ultrasound (SonoSite M-Turbo®, Sonosite, USA) guidance as described by Ra et al

All operations will be performed by the same surgeons. CO2 pneumoperitoneum will be introduced and intra-abdominal insufflation pressure will be limited to 12 mm Hg. After introducing of the four trocars, the patient will be placed in the reverse Trendelenburg position, using up to 30° of head-up tilt. No supplementary dose of muscle relaxant was administered 30 minutes before the end of the surgery.

After desufflation of CO2 pneumoperitoneum, the patient will be returned to the horizontal position and during skin closure; neuromuscular blockade will be antagonized with 50 µg kg-1 neostigmine and 10 µg kg-1 glycopyrrolate. At the last skin suture, desflurane will be discontinued and tracheal extubation will be performed at the discretion of the involved anesthetist in the patient's management.

A standard postoperative analgesic regimen, consisting of 12-hourly intravenous lornoxicam 8 mg, 6-hourly intravenous paracetamol 1 g and intravenous morphine PCA (incremental dose, 1 mg; lockout time, 6-min; a maximum 4-hourly limit, 30 mg), will be used in all patients. If the patient has persistent postoperative nausea and/or vomiting, metoclopramide 10 mg will be administered intravenously when needed.

Other independent investigators who will be blinded to the study protocol and the patient's randomization code will collect the patient's data.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologists class I and II patients
  • general anaesthesia

Exclusion criteria

  • cardiovascular disease
  • respiratory disease
  • neurological disease
  • renal disease
  • hepatic disease
  • hormonal disease
  • pregnancy
  • body mass index > 35 kg/m2)
  • smokers
  • alcohol abuse
  • use of antipsychotics
  • communication barriers
  • local anesthetics allergy
  • chronic use of opioids
  • use of nonsteroidal anti-inflammatory drug use during the 24 hours immediately preceding surgery
  • coagulation disorders
  • infection at the needle insertion
  • conversion of laparoscopic to open cholecystectomy

Treatment and study plan

Placebo

Drug

transversus abdominis plane block with saline 0.9%

Bupivacaine

Drug

transversus abdominis plane block bupivacaine 0.25%

Bupivacaine-Dexmedetomidine

Drug

transversus abdominis plane block with bupivacaine 0.25% with dexmedetomidine 1 µg Kg-1

Primary outcomes

  1. postoperative 24-hours cumulative morphine consumption

    Time frame: for 24 hours after surgery

    the retrieved postoperative 24-hours cumulative morphine consumption from the PCA pump report

Secondary outcomes

  1. cumulative use of fentanyl

    Time frame: for 2 hours during surgery

    the cumulative doses of fentanyl (from induction through the end of the surgery)

  2. postoperative pain at rest

    Time frame: for 24 hours after surgery

    the degree of postoperative pain at rest at 0.5, 2, 4, 6, 8, 12, 16, 20 and 24 h postoperatively

  3. postoperative pain on movement

    Time frame: for 24 hours aftersurgery

    the degree of postoperative pain at rest at 0.5, 2, 4, 6, 8, 12, 16, 20 and 24 h postoperatively

  4. sedation scores

    Time frame: For 24 hours after surgery

    the degree of sedation scores at 0.5, 2, 4, 6, 8, 12, 16, 20 and 24 h postoperatively

  5. Time to bowel recovery

    Time frame: for 24 hours after surgery

    the times to first flatus, defecation, intake of clear liquid, and solid food tolerated

Sponsors and collaborators

Lead sponsor

Imam Abdulrahman Bin Faisal University

Other

Collaborators

  • Mansoura University

Registry information

Official study title

Dexmedetomidine as an Adjuvant to Bupivacaine in Transversus Abdominis Plane Block for Laparoscopic Cholecystectomy: Multicentre Study

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 9, 2014
Registry last updated
Apr 6, 2015

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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