A randomised controlled study to assess the effectiveness of ultrasound guided bilateral erector spinae block (a type of inter-fascial plane block) for post-operative pain relief in laparoscopic (keyhole) abdominal surgeries.

Phase 2/3

Not yet recruiting

• Conditions: Administration,

• Registration Number: CTRI/2023/01/049255
• Lead Sponsor: Department of Anaesthesiology and Critical Care, JNMCH, AMU, Aligarh.

Brief Summary

A randomised controlled study to assess the efficacy of ultrasound guided bilateral erector spinae block for post-operative analgesia in laparoscopic abdominal surgeries:

During abdominal surgery pain is multifactorial.

Insufficient post-operative pain management hampers the achievement of good recovery after surgery and the risk of postoperative complications like delayed mobilization, ileus, nausea, chronic pain, with which patient’s satisfaction can seriously be affected with prolonged hospital stay that increases the financial burden both at the individual and societal level.

Thus, adequate post-operative pain management in patients undergoing abdominal surgery is though challenging but rewarding task.

Some of the efficacious analgesic options are intravenous drugs mainly the opioids, epidural block, fascial plane blocks like Transversus abdominis plane (TAP) block and Erector spine plane (ESP) block

Opioids are successful in the treatment of visceral pain but not so effective for somatic pain and are related to side effects such as constipation, nausea and vomiting, pruritus, and life threatening respiratory depression.

Frequent concerns with epidural block are hypo-coagulability and post-operative hypotension.

One of the recent techniques include facial plane blocks like Erector spine plane (ESP) and Transversus Abdominis Plane (TAP) block.

With ESP block, both visceral as well as somatic analgesia are provided, acute as well as chronic pain are relieved by it and can be utilised for analgesia at cervical, thoracic & m abdominal levels with minimal side effects. ESPB has shown significant analgesic effect with lesser pain scores and lower opioid consumption during various abdominal surgeries in the post-operative period.

In our study we will compare the efficacy of Ultrasound guided bilateral erector spine block in post-operative analgesia in abdominal surgeries with another group in which block won’t be given.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-02
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients undergoing elective laparoscopic abdominal surgery under general anaesthesia in JN Medical College and Hospital in time periods between 2022-24.
• ASA grade I and II.
• BMI between 18 to 25kg/sq.m.

Exclusion Criteria

• Patient’s refusal.
• History of allergy to analgesics.
• Allergic to local anaesthetic Skin infection at puncture site.
• Deranged coagulation profile.
• Pulmonary, renal, cardiac or any other systemic disorder.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of post-operative analgesia.	It will be assessed as time from the time of extubation to the time when patient request for the first dose of analgesic.

Secondary Outcome Measures

Name	Time	Method
NRS score for assessing post operative pain	First recording will be recorded in recovery room when patient will be well oriented to time place and person. It will be taken as 0 hour. Then it will be taken at 2nd hour, 6th hour and 24th hour. Further, mean of the four values will be taken.
Total analgesic required in 24hr period	Rescue analgesic when patient complains of pain with NRS score more than 3 (with minimum interval of 6 hours between two doses). Total doses of analgesic required by patient in 24 hours post-operatively will be calculated in morphine milligram equivalent dosage.
Complications- allergic reactions, nausea/vomiting, unsuccessful block, accidental intra-vascular injection & it’s consequences and pneumothorax.	Postoperatively, in first 24 hours.

Trial Locations

Locations (1)

Jawaharlal Nehru Medicine College and Hospital, AMU, Aligarh.; 🇮🇳 Aligarh, UTTAR PRADESH, India

Jawaharlal Nehru Medicine College and Hospital, AMU, Aligarh.

🇮🇳Aligarh, UTTAR PRADESH, India

Shariaa Ghufran

Principal investigator

8272869687

shariaa.amu@gmail.com