Quadratus Lumborum Block vs Transversus Abdominis Plane Block for Post-cholecystectomy Analgesia

NCT ID: NCT03323684

Last Updated: 2018-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2018-03-15

Brief Summary

In laparoscopic cholecystectomy, overall pain is a conglomerate of three different and clinically separate components: incisional pain (somatic pain) due to trocar insertion sites, visceral pain (deep intra abdominal pain), and shoulder pain due to peritoneal stretching and diaphragmatic irritation associated with carbon dioxide insufflation. Moreover, it has been hypothesized that intense acute pain after laparoscopic cholecystectomy may predict development of chronic pain (e.g., postlaparoscopic cholecystectomy syndrome). Without effective treatment, this ongoing pain may delay recovery, mandate inpatient admission, and thereby increase the cost of such care.

Recently, the uses of peripheral axial blocks that deliver local anesthetic into the transversus abdominis fascial plane have become popular for operations that involve incision(s) of the abdominal wall. Thus, the Transversus Abdominis plane (TAP) block has been shown to reduce perioperative opioid use in elective abdominal surgery, including open appendicectomy, laparotomy, and laparoscopic cholecystectomy. However, the efficacy of the TAP block is reportedly only reliable in providing analgesia below the umbilicus. The ultrasound-guided subcostal transversus abdominis (STA) block is a recently described variation on the TAP block which produces reliable supraumbilical analgesia. Deposition of local anesthetic in this plane has shown to block dermatomes T6 to T10 with an occasional spread to T12. This variant will be discussed in our study.

Currently, the Quadratus Lumborum block (QL block) is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery. The local anesthetic injected via the approach of the posterior QL block ( QL 2 block ) can more easily extend beyond the TAP to the thoracic paravertebral space or the thoracolumbar plane, the posterior QL block entails a broader sensory-level analgesic and may generate analgesia from T7 to L1. Use of posterior QL block in laparoscopic cholecystectomy has not been investigated before and it is the variant that will be discussed in our study.

Detailed Description

The aim of this study is to compare the analgesic efficacy of ultrasound guided posterior quadratus lumborum block and subcostal transversus abdominis plane block in laparoscopic cholecystectomy. The primary outcome will be assessment of postoperative opioid analgesic requirements. The secondary outcomes will include assessing intraoperative analgesic requirements, stress of trocar insertion and insufflation, postoperative visual analogue scale (VAS), length of stay at post-anesthesia care unit (PACU), time of first request to analgesia, incidence of nausea, and vomiting.

The study will hypothesize that quadratus lumborum block will be more superior than or equal to transversus abdominis block because it could cover all the dermatome segments from caudally L1 to cranially till T6 segments as the drug is expected to travel from the QL to the higher paravertebral spaces.

Conditions

Laparoscopic Cholecystectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Quadratus lumborum block Group (QL)

Quadratus lumborum block will be performed

Group Type: EXPERIMENTAL

Quadratus lumborum block Group (QL)

Intervention Type: OTHER

20 mL of 0.375% isobaric bupivacaine for each side deposited at the posterior aspect of the quadratus lumborum muscle (QLB type 2) using ultrasound after induction of general anesthesia and 15 minutes before start of surgery

Paracetamol infusion

Intervention Type: DRUG

Paracetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia.

Ketorolac analgesia

Intervention Type: DRUG

In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases and then every 8 hours.

fentanyl

Intervention Type: DRUG

With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, Fentanyl boluses (0.5 microgram.kg) will be given in case of increase in intraoperative mean arterial blood pressure or heart rate of more than 20% of baseline for longer than 5 minutes. Postoperatively, Fentanyl boluses (20 micrograms) will be given if VAS is more than 3 and it might be repeated after 30 minutes until VAS is ≤ 3.

Transversus abdominis plane Group (TAP)

Subcostal transversus abdominis plane will be performed

Group Type: EXPERIMENTAL

Transversus abdominis plane Group (TAP)

Intervention Type: OTHER

20 mL of 0.375% isobaric bupivacaine for each side using ultrasound after induction of general anesthesia and 15 minutes before start of surgery

Paracetamol infusion

Intervention Type: DRUG

Paracetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia.

Ketorolac analgesia

Intervention Type: DRUG

In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases and then every 8 hours.

fentanyl

Intervention Type: DRUG

With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, Fentanyl boluses (0.5 microgram.kg) will be given in case of increase in intraoperative mean arterial blood pressure or heart rate of more than 20% of baseline for longer than 5 minutes. Postoperatively, Fentanyl boluses (20 micrograms) will be given if VAS is more than 3 and it might be repeated after 30 minutes until VAS is ≤ 3.

Control group (C)

Postoperative analgesia will be accomplished with conjunction of paracetamol and ketorolac

Group Type: EXPERIMENTAL

Control group (C)

Intervention Type: OTHER

No intervention will be done

Paracetamol infusion

Intervention Type: DRUG

Paracetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia.

Ketorolac analgesia

Intervention Type: DRUG

In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases and then every 8 hours.

fentanyl

Intervention Type: DRUG

With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, Fentanyl boluses (0.5 microgram.kg) will be given in case of increase in intraoperative mean arterial blood pressure or heart rate of more than 20% of baseline for longer than 5 minutes. Postoperatively, Fentanyl boluses (20 micrograms) will be given if VAS is more than 3 and it might be repeated after 30 minutes until VAS is ≤ 3.

Interventions

Quadratus lumborum block Group (QL)

20 mL of 0.375% isobaric bupivacaine for each side deposited at the posterior aspect of the quadratus lumborum muscle (QLB type 2) using ultrasound after induction of general anesthesia and 15 minutes before start of surgery

Intervention Type: OTHER

Transversus abdominis plane Group (TAP)

20 mL of 0.375% isobaric bupivacaine for each side using ultrasound after induction of general anesthesia and 15 minutes before start of surgery

Intervention Type: OTHER

Control group (C)

No intervention will be done

Intervention Type: OTHER

Paracetamol infusion

Paracetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia.

Intervention Type: DRUG

Ketorolac analgesia

In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases and then every 8 hours.

Intervention Type: DRUG

fentanyl

With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, Fentanyl boluses (0.5 microgram.kg) will be given in case of increase in intraoperative mean arterial blood pressure or heart rate of more than 20% of baseline for longer than 5 minutes. Postoperatively, Fentanyl boluses (20 micrograms) will be given if VAS is more than 3 and it might be repeated after 30 minutes until VAS is ≤ 3.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• American Physical Status I or II

Exclusion Criteria

• Patient refusal.
• Hematological diseases
• bleeding disorders.
• Coagulation abnormality.
• Psychiatric diseases.
• Local skin infection
• sepsis at site of the block.
• Known intolerance to the study drugs.
• Body Mass Index > 40 Kg/m2.
• Emergency laparoscopic cholecystectomy
• if laparoscopic procedure converted to open.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamed Y Makharita, MD

Role: STUDY_CHAIR

Professor of Anesthesia and Surgical Intensive Care

Locations

Mansoura University, Faculty of Medicine

Al Mansurah, DK, Egypt

Mansoura University

Al Mansurah, DK, Egypt

Countries

Egypt

Other Identifiers

MD/17.09.09

Identifier Type: -

Identifier Source: org_study_id