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NCT Number: NCT03398564

Erector Spinae Plan Block for Postoperative Analgesia

Laparoscopic cholecystectomy is a widely employed procedure in ambulatory surgery. Pain after laparoscopic cholecystectomy arises significantly from port site incisions in the anterior abdominal wall. Innervation of the anterior abdominal wall is segmentally supplied by pain afferents in the plane of fascia between transversus abdominis and the internal oblique muscles. Opioids analgesia is used to control postoperative pain, but it carries the risk of increased nausea and vomiting, ileus and sedation that may delay hospital discharge.

Several techniques have been tried as.neuroaxial narcotics, intraperitoneal lavage of local anesthetic and transversus abdominis plan (TAP) block and successfully reduced opioid use and improve postoperative analgesia.

The ultrasound-guided erector spinae plan(ESP) block is a recently described technique which produces reliable unilateral analgesia at thoraco-lumbar dermatomes. ESP block carries the advantages of being simple, safe, easily recognizable by ultrasound, and a catheter can be threaded to extend the duration of analgesia.

Few case series reported the efficacy of (US)-guided ESP blocks in reducing postoperative pain and opioids consumption.

Because of that, the investigators aimed to test the hypothesis that US-guided ESP blocks can decrease opioid consumption during the first 24 h after of laparoscopic cholecystectomy in comparison with the conventional systemic analgesia.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al Jedaani group of hospitals

Jeddah, Meccah, 21462/7500, Saudi Arabia

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 60 ASA I- II adult patients
  • 20-60 years old
  • elective laparoscopic cholecystectomy
  • Body mass index (BMI) less than 35
  • Port sites at or above thoracic T 10 dermatome

Exclusion criteria

  • Allergy to amino-amide local anesthetics
  • Presence of coagulopathy
  • Local skin infection at the needle puncture sites
  • Preoperative chronic dependence upon opioid and NSAID medications
  • Liver or renal insufficiency
  • History of psychiatric or neurological disease
  • Deafness
  • previous open surgery that need the conversion of laparoscopic to open surgery or manipulations more than expected with more tissue trauma
  • American Society of Anesthesiologists (ASA) above Class II

Treatment and study plan

Erector Spinae Plan Block

Procedure

The trocar site incision was done 15 minutes after the block in the three groups. The skin was disinfected with chlorhexidine solution, and the high-frequency transducer was isolated with a sterile disposable plastic cover and gel. The patient was placed in lateral position. A high-frequency linear ultrasound probe was placed longitudinally lateral to the T8 spinous process by 3 cm. After identification of the 3 muscles superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. The needle was introduced in a cephalo-caudal orientation. The needle tip was positioned fascial plane between rhomboid major and erector spinae muscles. Hydrodissection by 1-2 ml of normal saline to visualize the plan, then deposition of local anesthetic was done. A total of 20 mL of 0.25% bupivacaine was injected here. The same procedure was repeated on the other side.

Oblique subcostal TAP

Procedure

ultrasound-guided bilateral oblique subcostal TAP block with bupivacaine 0.25% (20ml on each side)

Primary outcomes

  1. Morphine consumption

    Time frame: 24 hours postoperatively.

    It was calculated as equivalent morphine dose to the opioid analgesia consumed

Secondary outcomes

  1. Quality of analgesia

    Time frame: Every 2 hours for 24 hours postoperatively

    comparing visual analog scores (VAS) every two hours after surgery

  2. The intraoperative fentanyl

    Time frame: 2 hours

    (µg) required during surgery

  3. equivalent morphine dose in the recovery unit (PACU)

    Time frame: one hour

    equivalent morphine dose in the recovery unit (PACU)

  4. Erector spinae plan block complications

    Time frame: 24 hours postoperative

    local anesthetic systemic toxicity, vascular injury, and intravascular injection of local anesthetic

Sponsors and collaborators

Lead sponsor

Al Jedaani Hospital

Other

Registry information

Official study title

Efficacy of Ultrasound-Guided Erector Spinae Plan Block on Postoperative Pain After Laparoscopic Cholecystectomy Under General Anesthesia. Randomized, Controlled Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 12, 2018
Registry last updated
Dec 26, 2018

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

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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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