Erector Spinae Plan Block for Postoperative Analgesia

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03398564
• Other study ID #: 1/12
• Status: Completed
• Phase: N/A
• Start date: January 10, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: October 2018
• Source: Al Jedaani Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Saudi Arabia	Al Jedaani group of hospitals	Jeddah	Meccah

Sponsors (1)

Lead Sponsor	Collaborator
Al Jedaani Hospital

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption	It was calculated as equivalent morphine dose to the opioid analgesia consumed	24 hours postoperatively.
Secondary	Quality of analgesia	comparing visual analog scores (VAS) every two hours after surgery	Every 2 hours for 24 hours postoperatively
Secondary	The intraoperative fentanyl	(µg) required during surgery	2 hours
Secondary	equivalent morphine dose in the recovery unit (PACU)	equivalent morphine dose in the recovery unit (PACU)	one hour
Secondary	Erector spinae plan block complications	local anesthetic systemic toxicity, vascular injury, and intravascular injection of local anesthetic	24 hours postoperative