Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201809600342881 Date of Registration: 25/09/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ultrasound guided bilateral Quadratus Lumborum Block vs intrathecal morphine for postoperative analgesia after cesarean section: a randomized controlled study
Official scientific title Ultrasound guided bilateral Quadratus Lumborum Block vs intrathecal morphine for postoperative analgesia after cesarean section: a randomized controlled study
Brief summary describing the background and objectives of the trial ABSTRACT Background and objectives: Adequate pain control after cesarean section is important to help the newly delivered mothers to feed and care their neoborns together with early ambulation of the parturients to avoid the risk of thromboembolism and development of chronic abdominal and pelvic pain. The aim of the present study was to compare the efficacy of the Quadratus Lumborum (QL) block versus intrathecal morphine for postoperative analgesia after cesarean delivery. Methods: Ninety female patients with normal singleton pregnancies, a gestation of at least 37 weeks, and scheduled for elective cesarean section under spinal anesthesia were enrolled into the study. They were allocated randomly to receive (in addition to spinal anesthesia) either spinal morphine 100 µg (group ITM; n=30) or saline (group CG; n=30 and group QLB; n=30) and a postoperative bilateral QL block with either 24 ml of 0.375% ropivacaine (QLB) or saline (CG and ITM). Integrated Analgesia Score (IAS), Numerical rating scale (NRS) at rest and during movement, morphine requirements in the first 48-h, time to first ambulation, and morphine related side effects were recorded. Results: IAS and NRS scores at rest and during movements were significantly lower in QLB for longer durations (36-h and 24-h respectively) than in ITM (12-h and 6-h respectively) as compared to placebo. Morphine requirements in the first 48-h was significantly lower in QLB than ITM and CG (23±10.6 mg in QBL vs and 50±13.7 mg and 76±16.4 mg in ITM and CG respectively) (P=0.001). No significant difference between the three groups regarding time to first ambulation (13.4±1.8 h in QLB vs 11.7±1.9 h and 12.9±1.6 h in CG and ITM respectively). Incidence of morphine related side effects was significantly higher in ITM compared to CG and QBL. Conclusion: Quadratus Lumborum block, as part of a multimodal analgesic regimen, provided superior and prolonged analgesia compared to intrathecal morphine after cesarean delivery. Keywords
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial pain management after cesarean delivery
Anticipated trial start date 01/10/2017
Actual trial start date 01/10/2017
Anticipated date of last follow up 15/08/2018
Actual Last follow-up date 15/08/2018
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group intrathecal morphine 0.1 mg preservative-free morphine (0.1 ml) (Martindate Pharmaceuticals, UK) 48 hours Spinal anesthesia was performed while the patients were sitting under ultrasonographic guidance at the level of L2 to 3 or L3 to 4 intervertabral spaces using a 27-gauge pencil point needle (RapIDTM Spinal Needle Set Pencil Point Spinal Needle, Portex, Smiths Medical international Ltd, UK) with 12.5 mg of hyperbaric bupivacaine 0.5% (Astrazeneca Pharmaceuticals, UK) and 10 µg fentanyl (Martindate Pharmaceuticals, UK) combined with 0.1 mg preservative-free morphine (0.1 ml) (Martindate Pharmaceuticals, UK) 30
Experimental Group Quadratus lumborum block 24 ml of 0.375% ropivacaine was then slowly injected on each side 48 HOURS A convex (5-8 MHz) ultrasound probe (SonoScape ultrasonography machine, China) with a protective sheath was used after imaging depth and gain was adjusted. The procedure was carried out under complete aseptic condition (facemask, gown, and gloves). After cleaning of the abdominal skin with antiseptic solution; the probe was positioned transversely at the level of the anterosuperior iliac spine then advanced in the cranial direction to visualize the three muscle layers of the abdominal wall. Following the external oblique muscle posterolaterally, its posterior border was identified (hook sign) with the internal oblique muscle below it displayed as a roof above the QL muscle. The transducer was then tilted down to visualize the middle layer of the thoracolumbar fascia as a bright hyperechoic line. Stimuplex® A 21G 100-mm needle (B. BRAUN, Melsungen AG, Germany) was inserted in-plane under real time US guidance from anterolateral to posteromedial direction via the abdominal wall. Two mL of 0.9% saline was injected to visualize the solution spread (hydrodissection) to determine the optimal point of injection over the lumbar interfacial triangle. A volume of 24 ml of 0.375% ropivacaine was then slowly injected on each side after negative aspiration in 4 ml aliquots (in a total dose of 180 mg). 30
Control Group non non 48 hours Spinal anesthesia was performed while the patients were sitting under ultrasonographic guidance at the level of L2 to 3 or L3 to 4 intervertabral spaces using a 27-gauge pencil point needle (RapIDTM Spinal Needle Set Pencil Point Spinal Needle, Portex, Smiths Medical international Ltd, UK) with 12.5 mg of hyperbaric bupivacaine 0.5% (Astrazeneca Pharmaceuticals, UK) and 10 µg fentanyl (Martindate Pharmaceuticals, UK) combined 0.1 ml of 0.9% saline, the parturients were positioned supine with left uterine displacement of 15o - 20o and a facemask was applied to deliver oxygen at rate of 6 L/min. A convex (5-8 MHz) ultrasound probe (SonoScape ultrasonography machine, China) with a protective sheath was used after imaging depth and gain was adjusted. The procedure was carried out under complete aseptic condition (facemask, gown, and gloves). After cleaning of the abdominal skin with antiseptic solution; the probe was positioned transversely at the level of the anterosuperior iliac spine then advanced in the cranial direction to visualize the three muscle layers of the abdominal wall. Following the external oblique muscle posterolaterally, its posterior border was identified (hook sign) with the internal oblique muscle below it displayed as a roof above the QL muscle. The transducer was then tilted down to visualize the middle layer of the thoracolumbar fascia as a bright hyperechoic line. Stimuplex® A 21G 100-mm needle (B. BRAUN, Melsungen AG, Germany) was inserted in-plane under real time US guidance from anterolateral to posteromedial direction via the abdominal wall. Two mL of 0.9% saline was injected to visualize the solution spread (hydrodissection) to determine the optimal point of injection over the lumbar interfacial triangle. A volume of 24 ml of 24 ml of of 0.9% saline (placebo) on each side. 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
After approval of the hospital ethics committee, written informed consent was obtained from 90 ASA physical status II parturients; between the age of 19 and 40 years with a gestation of 37 weeks or more and normal singleton pregnancy, scheduled for elective C.S. via a Pfannenstiel incision under spinal anesthesia The exclusion criteria were as follows: history of allergy to any relevant drug, body mass index >35 kg/m2, coagulopathy, chronic pain disorders, pregnancy-induced hypertension, gestation diabetes mellitus, and opioids abuse. Adult: 19 Year-44 Year 19 Year(s) 40 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/09/2017 research ethics committee of Tanta university
Ethics Committee Address
Street address City Postal code Country
Tanta, Egypt tanta 4351 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure of this clinical study was the integrated analgesia assessment score at 2h, 6h, 12h, 24h, 36h, and 48h
Secondary Outcome the secondary outcome measures were morphine consumption in the first 48 hours, NRS pain scores at 2h, 6h, 12h, 24h, 36h, and 48h , time to first ambulation, patient’s satisfaction, and morphine related side effects including nausea and vomiting, sedation, pruritis, and respiratory depression. at 2h, 6h, 12h, 24h, 36h, and 48h
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta university hospital El gish street tanta 3427 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor non non non Egypt non
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Eman Salama dr.ers1975@yahoo.com 0020402231671 el estad street
City Postal code Country Position/Affiliation
tanta 6915 Egypt Lecturer of anesthesia and surgical ICU
Role Name Email Phone Street address
Scientific Enquiries eman salama dr.ers1975@yahoo.com 0020402231671 el estad street
City Postal code Country Position/Affiliation
tanta 6915 Egypt lecturer of anesthesia and surgical ICU
Role Name Email Phone Street address
Principal Investigator Eman Salama dr.ers1975@yahoo.com 0020402231671 el estad street
City Postal code Country Position/Affiliation
tanta Egypt Lecturer of anesthesia and surgical ICU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes One hundred eighteen patients were found eligible for the study. Eleven patients refused participation in the study and 17 patients met the exclusion criteria. So, ninety patients were enrolled in the study and randomized into three groups: CG (n=30), QLB (n=30), and ITM (n=30). No patient was excluded from the study thereafter due to deviation from the study protocol. The three groups were comparable regarding the baseline maternal characteristics (Table 1). IAS was significantly less with prolonged duration up to 36-h and 24-h (at rest and during movements respectively) in QBL group compared to 12-h and 6-h (at rest and during movements respectively) in ITM group (Figure 1 and 2). Total PCA morphine consumption during the first 48-h postoperatively was significantly lower in QLB group in comparison to ITM and CG group (23±10.6 mg in QBL vs 50±13.7 mg and 76±16.4 mg in ITM and CG respectively; P=0.001). Furthermore, NRS scores at rest and during movement were significantly less with QLB till 24-h and 12-h respectively compared to 6-h and 12-h respectively in ITM (Figure 3 and 4). Patients in QLB group were able to ambulate after 13.4±1.8 hours compared to 11.7±1.9 hours and 12.9±1.6 hours in the control group and the ITM group respectively with no significant difference between the three groups (p>0.05). A significantly higher number of patients suffered from pruritis in ITM group compared to control and QLB groups at 6 hours (Table 2). Moreover, incidence of mild to moderate PONV was significantly higher in ITM group (Tale 3). Most of patients in QLB were highly satisfied (93.3%) compared to less patients in CG and ITM (36.7% and 16.7% respectively) (Table 4). Sedation scale was not different among the three groups with no clinically detectable respiratory depression in any of the study patients (data not shown). 30/08/2018 20/09/2018
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