Erector Spinae Plan Block for Postoperative Analgesia

Sponsor
Al Jedaani Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03398564
Collaborator
(none)
70
1
3
10.6
6.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Erector Spinae Plan Block
  • Procedure: Oblique subcostal TAP
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Efficacy of Ultrasound-Guided Erector Spinae Plan Block on Postoperative Pain After Laparoscopic Cholecystectomy Under General Anesthesia. Randomized, Controlled Trial
Actual Study Start Date :
Jan 10, 2018
Actual Primary Completion Date :
Nov 30, 2018
Actual Study Completion Date :
Nov 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Group I (Control)

ultrasound guided Bilateral Erector Spinae Plan Block using isotonic saline

Procedure: Erector Spinae Plan Block
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.

Active Comparator: Group II (ESP)

ultrasound guided Bilateral Erector Spinae Plan Block with bupivacaine 0.25%

Procedure: Erector Spinae Plan Block
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.

Active Comparator: Group III(OSTAP)

Ultrasound-guided bilateral oblique subcostal TAP block

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

Outcome Measures

Primary Outcome Measures

  1. Morphine consumption [24 hours postoperatively.]

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

Secondary Outcome Measures

  1. Quality of analgesia [Every 2 hours for 24 hours postoperatively]

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

  2. The intraoperative fentanyl [2 hours]

    (µg) required during surgery

  3. equivalent morphine dose in the recovery unit (PACU) [one hour]

    equivalent morphine dose in the recovery unit (PACU)

  4. Erector spinae plan block complications [24 hours postoperative]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Al Jedaani group of hospitals Jeddah Meccah Saudi Arabia 21462/7500

Sponsors and Collaborators

  • Al Jedaani Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Al Jedaani Hospital
ClinicalTrials.gov Identifier:
NCT03398564
Other Study ID Numbers:
  • 1/12
First Posted:
Jan 12, 2018
Last Update Posted:
Dec 26, 2018
Last Verified:
Oct 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Al Jedaani Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 26, 2018